Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer

Abstract

Objectives:

Patients with hematologic cancer experience severe symptoms (i.e., insomnia, fatigue, pain, distress). Few interventions addressing insomnia and other symptoms exist for this population. Mindfulness-Based Therapy for Insomnia (MBTI) may be appropriate but has only been tested in healthy outpatients. This study aimed to develop and test an adapted MBTI protocol for hematologic cancer patients.

Methods:

Patient (n=3) and clinician (n=1) focus groups, and user-testing (N=5) informed adaptation of Mindful Night-to-Day (MBTI+). A single-arm pilot trial (N=32) evaluated feasibility (accrual, attrition, adherence), acceptability (intervention satisfaction), and changes to insomnia symptom severity (Insomnia Severity Index; primary outcome) and secondary outcomes (fatigue, pain, distress, pre-sleep arousal, mindfulness, symptom management self-efficacy) at baseline, post-intervention, and 1-month post-intervention. Descriptive statistics and paired sample t-tests were conducted.

Results:

Qualitative feedback informed MBTI+ content, format, and delivery. Mindfulness was used to increase symptom awareness (sleepiness vs. fatigue). Meditations and behavioral skills were applied to inpatient treatment. MBTI+ met feasibility (N=32/12 months; 8.1% attrition; 83.8% adherence) and acceptability (M=3.52/4.00) benchmarks. Insomnia symptom severity decreased (d=1.20) from baseline to post-intervention, as did most secondary outcomes.

Conclusions:

MBTI+ was feasible, acceptable, and showed promise for benefits throughout inpatient and outpatient treatment. Findings warrant further evaluation in a randomized trial.

Introduction

Hematologic malignancies account for nearly 10% of cancer diagnoses in the United States (Kaye & Isidori, 2021; Siegel et al., 2022). Survival has lengthened due to targeted therapies; however, treatment for life-threatening hematologic cancer is intensive and involves prolonged hospitalization (Siegel et al., 2022; Tallman et al., 2019). Patients with hematologic cancer report an average of eight severe and concurrent symptoms (e.g., insomnia, fatigue, pain, distress) throughout treatment (Albrecht, 2014; Albrecht et al., 2017; Castelli et al., 2022; LeBlanc et al., 2022; Tallman et al., 2019; Yang et al., 2018). Insomnia symptoms (e.g., difficulty falling asleep, staying asleep, and/or waking up too early) are especially prevalent (41–57%), and patients describe sleep difficulties as one of their most severe and distressing symptoms (Albrecht, 2014). Lack of sleep and distress related to lack of sleep can lead to unhelpful behaviors (e.g., extending time in bed, inconsistent sleep schedule, sleep medication use) that perpetuate insomnia symptoms (Spielman et al., 1987) and worsen daytime fatigue, pain, and distress, which further interfere with sleep (Castelli et al., 2022; Troy et al., 2019). Persistent insomnia symptoms can activate physiological processes (e.g., inflammation) that increase overall symptom burden and compromise treatment success and disease outcomes (Luskin et al., 2017; Palesh et al., 2014; Ruel et al., 2020). Insomnia and symptom management is a critical supportive care concern for patients with hematologic cancer.

Treatment for insomnia in cancer is often pharmacological, despite research suggesting this is suboptimal for patients (Reynolds & Ebben, 2017). Behavioral insomnia interventions are efficacious, cost-effective, and recommended as first-line treatment by the American Academy of Sleep Medicine (Edinger et al., 2021). Mindfulness-Based Therapy for Insomnia (MBTI) is a group-based, behavioral intervention that combines sleep consolidation (i.e., sleep restriction) and sleep reconditioning (i.e., stimulus control) with training in mindfulness principles and meditations (Ong, 2017). This mindfulness-based protocol emphasizes non-judgmental, present-moment awareness and acceptance of insomnia, and disruptive thoughts related to lack of sleep. This approach is likely well-suited to the challenging and often uncontrollable treatment and symptom demands faced by hematologic cancer patients. To date, MBTI has only been tested in healthy outpatients with insomnia (Ong et al., 2014; Perini et al., 2023)

Mindfulness-based interventions (MBIs), not specifically focused on insomnia (e.g., Mindfulness-Based Stress Reduction), can improve sleep quality in cancer survivors (Zeichner et al., 2017). However, effects are mixed and typically less than treatment protocols specifically targeting insomnia symptoms (Garland et al., 2014; McCloy et al., 2022; Suh et al., 2021). Further, most prior work has been conducted in solid tumor cancers (Garland et al., 2014). MBIs have been rarely applied to patients with hematologic malignancies (Zhang et al., 2017), and those that exist do not adequately address the numerous severe and concurrent symptoms (e.g., insomnia, fatigue, pain, distress) reported during intensive treatment.

MBTI is unique in that it leverages instruction in mindfulness principles and meditations, and behavioral insomnia strategies. Still, MBTI needs to be adapted to meet the unique treatment and symptom burden of hematologic cancer patients. MBTI is traditionally delivered in-person using a group format. Hematologic cancer treatment is physically demanding, time-consuming, and results in immunosuppression. MBTI needs to be adapted so it can be delivered remotely via videoconferencing, and individually for better flexibility around ongoing treatment. MBTI was developed to address insomnia, yet hematologic cancer patients experience many other bothersome symptoms (e.g., fatigue, pain, distress) that contribute to poor sleep (Castelli et al., 2022; El-Jawahri et al., 2019; Hochman et al., 2018; Kayastha et al., 2018; Troy et al., 2019). There is no mindfulness-based intervention for hematologic cancer patients that systematically addresses insomnia, as well as fatigue, pain, and distress. An adapted MBTI protocol for this population should provide training in behavioral skills to cope with these symptoms and their interference to sleep quality. Such a protocol could reduce cancer morbidity for a high-risk yet relatively understudied cancer population.

We sought to develop and pilot test an adapted MBTI protocol (Mindful Night-to-Day [MBTI+]) for individual, remote delivery to hematologic cancer patients reporting insomnia symptoms, as well as fatigue, pain, and/or distress after inpatient treatment. First, we aimed to adapt the MBTI+ protocol via patient and clinician focus groups, followed by user testing. Second, we aimed to examine the feasibility and acceptability of the MBTI+ protocol through a single-arm pilot. We hypothesized the protocol would be feasible (i.e., accrual N=30/15 months; ≤20% attrition; ≥80% adherence) and acceptable (i.e., ≥80% satisfaction). Finally, we aimed to examine outcome patterns suggesting promise for further testing of MBTI+. We hypothesized that insomnia symptom severity (primary outcome) and secondary outcomes (i.e., fatigue, pain, distress, mindfulness, symptom management self-efficacy) would improve from baseline to post-intervention (primary endpoint) and 1-month post-intervention.

Materials and Methods

Participants

All participants were recruited from the Duke University Health System. Eligibility criteria included; 1) initial or recurrent diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, Non-Hodgkin’s lymphoma, multiple myeloma, or myelodysplastic syndrome; 2) ≤8 weeks post-discharge from inpatient chemotherapy or chimeric antigen receptor t-cell therapy; 3) ≥8 on the Insomnia Severity Index (Bastien et al., 2001) for the past two weeks; 4) ≥5/10 for “worst” fatigue, pain, or distress in the past two weeks (Cleeland et al., 2000); 5) ≥3/10 symptom interference on ≥2 activities of living (i.e., work, mood) in the past two weeks; 6) ability to speak and read English; and 7) age ≥18 years. Exclusion criteria included: 1) cognitive impairment; 2) severe psychiatric (e.g., schizophrenia) or medical condition (e.g., narcolepsy) that would contraindicate safe participation; and/or 3) expected survival of ≤6 months. Eligible clinicians for the focus group were healthcare professionals (e.g., nurse, pharmacist) in the Duke Division of Hematologic Malignancies and Cellular Therapy.

Procedure

Recruitment.

The trial was approved by the Duke Institutional Review Board (IRB: Pro00107338) and registered on ClinicalTrials.gov (NCT04736056). Participants were recruited between May 2021 and February 2023. Study staff determined initial eligibility by reviewing the Hematologic Malignancies and Cellular Therapy inpatient census list in the electronic medical record. Potentially eligible patients were emailed a recruitment letter and then called by study staff to describe the study purpose, procedures, risks and benefits, and provide potential participants with an opportunity to ask questions. Interested patients completed a brief screening interview via telephone to assess eligibility. If eligible, patients electronically signed IRB-approved consent forms via Zoom.

Focus Groups.

Participants recruited to focus groups (n=3 patient, n=1 clinician focus groups) were asked to evaluate the adapted Mindful Night-to-Day protocol (MBTI+). Guidelines suggest that four focus groups can yield thematic saturation, and one or more focus groups per stratum (i.e., patient, clinician) can further enhance understanding of themes (Hennink et al., 2019). The proposed MBTI+ intervention integrated Mindfulness-Based Therapy for Insomnia (Ong, 2017) and evidence-based behavioral skills from Pain Coping Skills Training (Kelleher et al., 2019). Semi-structured interview guides queried participants on proposed intervention content (e.g., mindfulness, symptom coping skills) and format (e.g., session number, frequency, length, delivery, intervention materials), as well as common symptoms experienced during treatment (see Appendix). Each intervention skill was described and linked to its intended target (i.e., nighttime sleep difficulties, daytime symptoms of fatigue, pain, and distress). Participants were asked to share their impressions of most/least helpful aspects of the intervention, current symptom management techniques, and potential barriers to intervention completion. Focus groups were approximately 60–75 minutes and conducted via Zoom. Patients were compensated $30, while clinicians received a $15 giftcard. Focus groups were audio-recorded and transcribed verbatim by a study staff member who did not attend the groups. Focus group participants were not eligible to participate in user testing or the single-arm pilot.

User Testing and Single-Arm Pilot.

Participants recruited to user testing (N=5) completed the full, videoconferenced MBTI+ intervention. Feedback was solicited from user testers at the end of Session 6 to further refine the protocol. The finalized videoconferenced MBTI+ intervention was tested in a single-arm pilot trial (target N=30) to assess feasibility, acceptability, and pre-post intervention changes to outcomes. User testing and single-arm pilot participants completed self-report assessments via REDCap (Harris et al., 2019) at baseline (A1), post-intervention (A2), and at 1-month follow-up (A3). Participants received $40 per assessment.

Intervention

A PhD-level clinical psychologist skilled in behavioral sleep medicine and symptom management delivered the manualized MBTI+ intervention over six, 60-minute, videoconferenced sessions. The MBTI+ manual (available upon request) includes a detailed script for delivering each session, along with relevant logistical (e.g., accessing meditation recordings) and clinical (e.g., practicing non-judgement) reminders to the therapist. Participants received session handouts and study materials (e.g., sleep diaries, mp3 player and study website with mindfulness meditation recordings). All sessions had the same structure: 1) set agenda; 2) review prior session content, sleep diaries, and home practice of skills; 3) mindfulness meditation with discussion; 4) present new content; 5) address questions and assign home practice (Table 1).

Table 1.

Mindful Night-to-Day (MBTI+) Intervention Content

Session	Mindfulness Component(s)	Sleep Component(s)	Symptom Coping Component(s)	Home Practice
1	• Definition of mindfulness • Key principles of mindfulness • Mindful eating exercise	• Review 3-P Model of Insomnia (Spielman et al., 1987)		• Practice mindful eating • Daily sleep diary
2	• Using mindfulness to cope with symptoms (e.g., insomnia, fatigue, pain, and stress) • Sitting meditation	• Sleep hygiene for home and hospital	• Activity-rest cycle for pacing activities at home and hospital • Maintain activity to cope with symptoms and build sleep drive	Practice sitting meditation and activity-rest cycle Sleep hygiene Daily sleep diary
3	• Using mindfulness to distinguish sleepiness from fatigue, and corresponding coping response • Walking meditation	• Sleep consolidation (sleep restriction) • Sleep reconditioning (stimulus control) • Soothing activities for wakefulness at home and hospital	• Pleasant activity planning for at home and hospital • Engage in pleasant activities to cope with symptoms, and build sleep drive	• Practice walking meditation and pleasant activity planning • Follow time-in-bed schedule • Daily sleep diary
4	• Body scan meditation	• Review sleep diaries; adjust time-in-bed schedule • Discuss sleep efficiency • Discuss territory of insomnia (i.e., symptoms, behaviors, and thoughts that make up insomnia experience)		• Practice body scan meditation • Monitor territory of insomnia • Follow time-in-bed schedule • Daily sleep diary
5	• Applying mindfulness principles of acceptance and letting go to symptom experience • Mindful movement meditation (standing and sitting series)	• Review sleep diaries and sleep efficiency • Adjust time-in-bed schedule	Calming self-statements (e.g., “Let this be,” “I will allow this feeling to come and go”) as a reminder to practice acceptance and letting go	• Practice mindful movement meditation • Practice calming self-statements • Follow time-in-bed schedule • Daily sleep diary
6	• 3-minute mini-meditation; formal vs. informal meditations • Self-compassion: review ratio of nurturing to depleting activities	• Review sleep diaries and sleep efficiency • Adjust time-in-bed schedule	• Goal setting for skill practice	• Continue skill practice

Note. Bold text signifies intervention content that was adapted for patients with hematologic cancer. Text left unbolded is standard to traditional Mindfulness-Based Therapy for Insomnia (MBTI; Ong, 2017).

Intervention Fidelity

All sessions were audio-recorded and a random sample of 10% (N=18) was assessed by an independent research coordinator using a fidelity checklist adapted from previous trials (Somers et al., 2023). Competence (M=4.97/5.00, SD=.10) and adherence (M=4.96/5.00, SD=.13) were excellent.

Measures

Demographics and Medical Characteristics.

At baseline, participants self-reported demographic (e.g., race, ethnicity, partner status, education, employment) and medical (e.g., cancer treatment, sleep, pain, and/or depressive/anxiety medication) characteristics. Study staff confirmed medical characteristics via electronic medical record review.

Feasibility and Acceptability.

A priori feasibility benchmarks included: 1) target accrual (N=30) within 15 months; 2) ≤20% attrition, defined as the percentage of participants who completed the post-intervention assessment; and 3) ≥80% of participants completing all 6 intervention sessions. Acceptability benchmark was ≥80% of participants reporting intervention satisfaction (i.e., Client Satisfaction Questionnaire [CSQ] M ≥3.00/4.00). The 10-item CSQ (Attkisson & Zwick, 1982) was used to assess acceptability at post-intervention. Items were rated on a 4-point scale from 1 (low acceptability) to 4 (high acceptability) and averaged to obtain an acceptability score (α=.95).

Primary Outcome.

Perceived insomnia severity was assessed with the Insomnia Severity Index (ISI; (Bastien et al., 2001)). The ISI consists of three items assessing difficulty falling asleep, difficulty staying asleep, and problems waking up too early in the past two weeks. Responses range from 0 (no difficulty) to 4 (very severe difficulty). The ISI also includes four items assessing satisfaction with sleep, how noticeably insomnia impairs quality of life, distress regarding current sleep disturbance, and interference to daily functioning. Items are summed to yield a total score, with higher scores indicating worse insomnia symptoms (0–7: no clinical insomnia; 8–14: subthreshold; 15–21: moderate; 22–28: severe).

Secondary Outcomes.

Fatigue severity and interference were assessed by the Fatigue Symptom Inventory (FSI; (Hann et al., 2000)). Pain severity and interference were measured with the Brief Pain Inventory (BPI; (Cleeland & Ryan, 1994)). Distress (i.e., anxiety and depressive symptoms) was measured by the Hospital Anxiety and Depression Scale (HADS; (Snaith, 2003)). Pre-sleep cognitive and somatic arousal were assessed by the Pre-Sleep Arousal Scale (PSAS; (Nicassio et al., 1985)). Mindfulness skills (e.g., observing, describing, awareness, non-judgement) were measured using the Kentucky Inventory of Mindfulness Skills (KIMS; (Baer et al., 2004)). Symptom management self-efficacy was assessed using the Self-Efficacy for Management Chronic Disease Scale (Lorig et al., 2001), with an additional item to assess self-efficacy for managing insomnia.

Analyses

Focus Groups.

Qualitative analysis of focus group transcriptions was conducted using rapid analysis, which can inform intervention development more quickly than traditional, often lengthy qualitative procedures (e.g., thematic analysis; Lewinski et al., 2021; Taylor et al., 2018) and thereby expedite subsequent pilot testing. Transcripts were reviewed by two independent coders to summarize participant responses by domain and identify key themes. Findings informed intervention procedures and material refinement. Our team has previously used this approach to develop behavioral interventions for cancer patients (Kelleher et al., 2022).

User Testing and Single-Arm Pilot.

Descriptive statistics were calculated using SPSS (Version 27). Paired samples t-tests were computed for user testing and single-arm pilot participants that completed all 6 MBTI+ sessions to explore changes in primary and secondary outcomes from baseline to post- and 1-month post-intervention. This was a small feasibility study, thus p-values were not reported and effect sizes (Cohen’s d) were exploratory.

Results

Patient and Clinician Focus Groups

There were three patient (N=2, 5, and 3) and 1 clinician (N=6) focus groups. Table 2 presents qualitative feedback across domains, with corresponding changes to the protocol and illustrative quotes. Patients (M_age=57; 70% Male; 70% White; 30% Black; 100% Non-Hispanic/Latino; 60% Diffuse Large B-Cell Lymphoma, 20% Acute Myeloid Leukemia, 20% Mantle Cell Lymphoma; see Supplemental Table 1 and Table 2) and clinicians (M_age=36; 100% Female; 83% White; 17% Black; 100% Non-Hispanic/Latino; 1 nurse, 2 nurse practitioners, 1 physician assistant, 2 pharmacists) described inpatient sleep quality as poor and slow to improve post-discharge. Difficulty falling asleep and staying asleep were the most prevalent insomnia symptoms. Pain, and especially fatigue, were frequent and bothersome symptoms. Patients shared that they nap to cope with fatigue and pain, but napping interferes with sleep. Distress due to uncertainty of disease course and treatment success was also commonly endorsed. Patients and clinicians were enthusiastic about sleep consolidation (i.e., sleep restriction) and sleep reconditioning (i.e., stimulus control) strategies, meditations to promote awareness of symptoms and emotions, and behavioral coping skills (e.g., activity-rest cycle, pleasant activity planning) to manage fatigue, pain, and distress that impact sleep. Patients and clinicians agreed that 6, weekly sessions delivered one-on-one via Zoom was appropriate, but felt the proposed session length (60–75 minutes) was too long. Intervention barriers were time commitment and recurrent hospitalizations.

Table 2.

Qualitative Findings from Patient and Clinician Focus Groups

Domains	Patients	Providers	Illustrative Quotes	Changes to Protocol
Impression of Content
Mindfulness and Meditation	• New for most but interested • Felt it would be helpful	• Useful for managing cancer symptoms and coping in general	• Patient: “If I can find some kind of way to incorporate the mindfulness meditation, I think it would be great” • Provider: “…the mindfulness meditations, I think that could be used in a setting outside of their diagnosis and what’s going on with them at that time and just learning how to just cope in general”	• Included examples of definitions for mindfulness (e.g., “focusing on here and now”) and meditation (e.g., “noticing what is going on around you”) from focus group patients in sessions handouts
Symptom Coping Skills	• Not much familiarity with symptom coping skills but felt they would be helpful; interested activity-rest cycle, pleasant activity planning, and focusing on the positive • Familiar with stimulus control and sleep hygiene	• Symptom coping skills could be helpful if patients translated them to hospital	• Patient: “I do about everything but sleep in the bed” • Patient: “Doing fun things and focusing on the good and being grateful is important”	• Incorporated activity-rest cycle, pleasant activity planning, calming self-statements and goal setting for skills practice into MBTI+ intervention
Most Helpful	• Likely patient-dependent but overall, most felt that all skills would be helpful	• Skills could help patients move away from just taking meds to improve symptoms	• Patient: “I think that everything you have indicated would be potentially very helpful” • Provider: “You know reemphasizing that there are other methods to treat some of the problems that they may be having”	NA
Least Helpful	• Nothing noted	• Nothing noted		NA
Format
Number and Frequency of Sessions	• 6 sessions is appropriate • Preference for weekly sessions	• 6 sessions is appropriate • Consider two, shorter sessions per week	• Patient: “Six hours of helping, you know, deal with some of these things, would be very helpful”	NA
Length of Sessions	• 60–75 min is too long • Need to be flexible given treatment schedule and symptom burden	• 60–75 min is too long • Consider two, shorter sessions per week	• Patient: “…body is going through so much” • Provider: “…for some patients even an hour could be lengthy. Um I don’t know if they’ll have the energy or the attention span”	• Reorganized content to keep sessions to ≤60 mins
Delivery Modality	• Some prefer in-person but understand Zoom is more safe/feasible • Some apprehensive about technology	• Zoom could be challenging for some patients with less comfort with technology	• Patient: “I like it [Zoom]” • Provider: “…still some homes that do not have computers”	• Developed instructions for accessing Zoom • Option to loan iPad for Zoom access if needed
Intervention Materials	• Liked idea of having physical binder for session handouts • Liked the idea of having mp3 player and study website for mindfulness recordings	• Nothing noted	• Patient: “Very helpful to have something written”	NA
Challenges/Barriers to Completing Intervention	• Session length, recurrent hospitalization, symptom burden, other responsibilities (e.g., work, family)	• Motivation, time commitment, lag from skill acquisition to observed benefit	• Provider: “They may want something to happen overnight” • Provider: “I just worry about sort of the disconnect between the inpatient setting and the outpatient setting”	• Shortened sessions • Allowed for flexible session timeline given treatment and/or symptom disruptions • Incorporated content on practice of skills at home and in hospital, and addressing barriers to practice
Symptoms
Insomnia Symptoms	• Sleep while inpatient is poor due to disruptions and can be slow to improve once home • Trouble falling asleep and staying asleep are most common • Some have insomnia before treatment, and it gets worse	• Some have sleep problems before treatment, and it gets worse • Interruptions during the night while inpatient make sleep difficult	• Patient: “…you can’t sleep in the hospital. I mean if I can get 3 hours before being tested whether it’s just vital signs or whatever…three hours would be a real achievement uh so in the hospital there is not a lengthy sleep period.” • Patient: “I can go to sleep, I just can’t stay asleep”	• Used term “sleep problems” versus “insomnia” • Added common reasons for sleep problems to session handouts, e.g., stress/ anxiety, medications, nighttime disruptions, environment change
Fatigue	• Most bothersome symptom • Often need to take naps • Body feels drained in the hospital, slow to improve • Easy to do too much and make fatigue worse	• Hear about fatigue the most	• Patient: “I can just feel the muscles fatigue. Like I just ran a marathon” • Patient: “I just give out so easy” • Provider: “So like literally everything that’s happening here is making them tired”	• Emphasize use of activity-rest cycle for fatigue • Added common reasons for fatigue to session handouts, e.g., diagnosis, low blood counts, Benadryl
Pain	• Minimal pain noted • Some endorsed: pain from acid reflux, bone pain, neuropathy, or existing pain conditions (e.g., arthritis)	• Pain can be related to tumor load, bone lesions, and/or treatment procedures	• Patient: “Things ache once [I] lay down” • Patient: “Bone pain doesn’t feel like regular pain” • Provider: “[Patients]…getting poked and prodded a lot, and that causes pain”	• Added common reasons for pain to session handouts, e.g., diagnosis/tumor load, procedures, swollen lymph nodes, bone lesions
Distress	• Stress is common due to: uncertainty surrounding treatment course/success, limits to functioning/ activities, finances, transportation etc.	• Feelings of uncertainty and anxiety are common • Concerned about loved ones • Financial stress	• Provider: “…the amount of uncertainty that exists in the hospital setting is very challenging and very stressful”	• Added common sources of stress to sessions handouts
Interaction of symptoms	• Daytime napping interferes with sleep at night • Acid reflux interferes with sleep at night • Pain can be worse once lying down at night	• Common for symptoms to interact, in bad and good ways • Pain medications make patients sleep during the day, disrupting nighttime sleep	• Provider: “Because suddenly it’s like their world changes. Like, they’re like “I got a good night sleep last night and life is so much better!” • Provider: “So it is all very much intertwined”	• Emphasized distinction between sleepiness and fatigue, and coping response • Added content on interaction of symptoms to session handouts
Managing Symptoms
Self	• Strategies to manage symptoms included: physical activity, support from family and friends, sleep hygiene, naps, prayer, Epsom salts baths, deep breathing	NA	• Patient: “Well of course the ultimate goal is you wanna live” • Patient: “Because worrying about stuff in the uh past or in the future that is out of your control is kinda a waste of time when you could be enjoying the moment”	• Added all suggestions to therapist manual to discuss with patient for use at home and in the hospital
Medical Team	• Strategies that medical team uses to manage symptoms: medication, referral to supportive care services (e.g., nutritionist, recreational therapy)	• Strategies that medical team uses to manage symptoms: medication, transfusions, referral to supportive care services (e.g., stress management, chaplain), visits from family/friends, outline daily schedule for patient, adhere to “quiet hours” in the ward during the nighttime	• Provider: “I think patients like to have that even if it’s something as simple as melatonin. They like to feel like we [are] offering them something tangible that can help” • Provider: “Whether it’s medications, or vital signs, or labs, um despite our best efforts to cluster things it’s never gonna be, or very rarely to their satisfaction in terms of a restful, uninterrupted amount of sleep time”	• Added note in therapist manual regarding melatonin • Added all suggestions to therapist manual to discuss with patient for use at home and in the hospital
Implementation
Impact of Intervention on Clinician’s Experience	NA	• Would help to know patients have techniques to manage symptoms • Patient involvement in this intervention would indicate they are invested in their care	• Provider: “I think if we can continue to emphasize it, and hopefully if people actually see some benefit from it, they’ll continue to use the strategies that they’re learning”	NA

Based on this input, content was added to the intervention distinguishing fatigue (e.g., lack of energy, decreased motivation) from sleepiness (e.g., physiological readiness for sleep). Mindfulness skills (e.g., awareness) and meditations (e.g., sitting meditation) were presented as tools to differentiate fatigue from sleepiness. The activity-rest cycle, a behavioral technique for pacing activity with short periods of rest, was included as a strategy to manage fatigue and pain, and help patients increase activity level. Pleasant activity planning (i.e., behavioral activation) was also added and introduced as a way to increase the level and range of pleasant activities to better cope with fatigue, pain, and stress, and build sleep drive throughout the day. Recurrent hospitalization for additional treatment is common, thus recommendations for using intervention strategies while inpatient were added (Figure 1). Session length was shortened (60 minutes) and the timeframe for completing sessions was lengthened.

Figure 1.

Example Participant Handouts from Mindful Night-to-Day (MBTI+)

Feedback from user testers after completing the adapted MBTI+ intervention was positive, with minimal suggested revisions to the protocol. The only recommended change was adding a brief review of prior session content to the beginning of each session. A review page was added to the session handouts and discussed with participants prior to covering new content.

User Testing and Single-Arm Pilot

Study Flow.

Study staff called 163 patients; 51.5% (84/163) were excluded before screening because they declined participation (n=70) or could not be reached by phone and/or email (n=14). Primary reasons for declining participation were lack of interest (n=34) or time commitment (n=19). Of those who completed screening (n=79), 48 (60.8%) met inclusion criteria, and 77.1% (37/48) consented (Figure 2).

Figure 2.

CONSORT

Note. OSA=obstructive sleep apnea

Participant Characteristics.

Participants were more than half female (56.8%), White (78.4%), and non-Hispanic (89.2%). Average age was 48.8 (SD=19.37) years. The most common cancer diagnosis was Diffuse Large B-Cell Lymphoma (27.0%). Additional demographic and medical characteristics are reported in Table 3 and 4, respectively.

Table 3.

Demographic Characteristics (N=37)

	N (%) or M (SD)
Age (years)	48.76 (19.37)
Gender
Male	16 (43.2)
Female	21 (56.8)
Race
White	29 (78.4)
Black or African American	5 (13.5)
Asian	2 (5.4)
2 or more Races	1 (2.7)
Ethnicity
Non-Hispanic or Latino	33 (89.2)
Partner Status
Married/Partnered	18 (48.6)
Not Married/Partnered	2 (5.4)
Single	7 (18.9)
Divorced	3 (8.1)
Separated	1 (2.7)
Widowed	6 (16.2)
Education
High School Diploma	3 (8.1)
Some College	17 (45.9)
Bachelor’s Degree	10 (27.0)
Graduate Degree	7 (18.9)
Employment
Working Full Time	12 (32.4)
Working Part Time	3 (8.1)
Not Currently Employed, Looking for Work	5 (13.5)
Retired	8 (21.6)
Homemaker	2 (5.4)
Self-Employed	1 (2.7)
Disability	5 (13.5)
Student	1 (2.7)

Note. Statistics shown for participants in user testing and single-arm pilot;

M=mean; SD=standard deviation.

Table 4.

Medical and Treatment Characteristics (N=37)

Cancer Type	N (%) or M (SD)
Acute Myeloid Leukemia	9 (24.3)
Acute Lymphoblastic Leukemia	9 (24.3)
Burkitt’s Lymphoma	2 (5.4)
Diffuse Large B-Cell Lymphoma	11 (29.7)
Follicular Lymphoma	2 (5.4)
Mantle Cell Lymphoma	2 (5.4)
T-Cell Lymphoblastic Lymphoma	1 (2.7)
Acute Promyelocytic Leukemia	1 (2.7)
Initial Diagnosis or Recurrence
Initial Diagnosis	31 (83.8)
Recurrence	6 (16.2)
Time since Diagnosis (months)	3.31 (5.77)
Length of Hospitalization (days)	18.19 (13.54)
Treatment
Chemotherapy	33 (89.2)
Immunotherapy (e.g., CAR-T)	4 (10.8)
Medications
Sleep Medication	11 (29.7)
Pain Medication	20 (54.1)
Depression/Anxiety Medication	6 (16.2)

Note. Statistics shown for participants in user testing and single-arm pilot; M=mean;

SD=standard deviation. CAR-T= chimeric antigen receptor t-cell therapy.

Feasibility and Acceptability.

The MBTI+ protocol met all feasibility and acceptability benchmarks. The accrual goal for the single-arm pilot (N=30) was reached after 11 months, 4 months ahead of the 15-month study period. Two additional patients expressed interest and were enrolled, bringing total accrual to N=32 in 12 months. Across user testing and the single-arm pilot, retention was high and surpassed the goal of ≤20% attrition; only 3 participants (8.1%) did not complete A2. Adherence was good, with 89.2% (33/37) completing ≥3 intervention sessions and 83.8% (31/37) completing all 6 sessions. About 92% (34/37) of participants completed A2, and 89.2% (33/37) completed A3 (see Figure 2). Sessions were an average of 62 minutes long (SD=9.51) and completed within M=6.64 weeks (SD=1.76). Intervention satisfaction was high (M=3.52, SD=0.53), and even higher for those completing all 6 sessions (M=3.59, SD=0.50). Twenty-nine participants (93.5%) reported an average satisfaction score ≥3, exceeding our benchmark of 80% intervention satisfaction.

Changes in Outcomes.

Participants demonstrated improvement from A1 (M=13.45, SD=6.19) to A2 (M=6.26, SD=4.46) on insomnia symptom severity (primary outcome), with a large effect size (d=1.20, 95% CI [.73, 1.66]). Nearly all secondary outcomes (i.e., fatigue, pain, anxiety and depressive symptoms, pre-sleep arousal, mindfulness, symptom management self-efficacy) improved from A1 to A2, with effect sizes ranging from small to large (Table 5). Insomnia symptoms (d=1.07, 95% CI [.61, 1.51]) and all secondary outcomes improved from A1 to A3 (M=6.07, SD=3.99), with some effects being larger than those from A1 to A2.

Table 5.

Outcome Measures Across Time

Outcome		M (SD)			A1 to A2 (n=31 pairs)				A1 to A3 (n=30 pairs)
							95% CI for d				95% CI for d
		A1	A2	A3	t	d	Lower	Upper	t	d	Lower	Upper
Primary outcome	α
Insomnia	.89	13.45 (6.19)	6.26 (4.46)	6.07 (3.99)	6.67	1.20	.73	1.66	5.85	1.07	.61	1.51
Secondary outcomes
Fatigue
Severity	.88	4.48 (1.97)	3.69 (2.03)	4.06 (2.32)	1.94	.35	−.02	.71	1.37	.25	−.12	.61
Interference	.94	4.18 (2.49)	2.70 (2.55)	3.09 (2.44)	4.37	.78	.38	1.18	2.72	.50	.11	.87
Pain
Severity	.91	2.59 (2.19)	2.13 (2.01)	1.79 (1.89)	1.27	.23	−.13	.58	1.71	.31	−.05	.68
Interference	.97	3.35 (3.18)	2.57 (2.87)	1.85 (2.26)	1.79	.32	−.04	.68	3.34	.61	.22	1.00
Distress
Anxiety	.84	6.65 (4.22)	5.55 (4.08)	5.47 (4.33)	2.12	.38	.01	.74	2.59	.47	.09	.85
Depression	.87	6.61 (4.26)	5.74 (4.67)	5.20 (4.00)	1.61	.29	−.07	.65	3.29	.60	.21	.99
Pre-Sleep Arousal
Somatic	.68	14.42 (5.89)	11.65 (3.08)	11.90 (3.99)	2.99	.54	.16	.91	2.78	.51	.12	.89
Cognitive	.86	18.61 (7.16)	15.13 (5.48)	15.40 (6.73)	4.97	.89	.47	1.30	3.61	.66	.26	1.05
Mindfulness	.84
Observe		36.29 (9.00)	39.23 (8.46)	39.37 (9.32)	−2.21	−.40	−.76	−.03	−1.87	−.34	−.71	.03
Describe		28.74 (5.85)	28.74 (5.68)	29.70 (5.68)	.00	.00	−.35	.35	−1.52	−.28	−.64	.09
Awareness		32.32 (5.78)	32.77 (5.52)	31.57 (5.46)	−.54	−.10	−.45	.26	.49	.09	−.27	.45
Non-Judgement		32.00 (8.43)	34.29 (5.72)	33.77 (8.16)	−1.97	−.35	−.71	.01	−1.60	−.29	−.65	.08
Symptom Self-Efficacy	.91	6.05 (2.17)	6.88 (1.82)	6.90 (1.91)	−1.90	−.34	−.70	.03	−2.60	−.47	−.85	−.09

Note. Statistics shown are for user testing and single-arm pilot participants that completed all six MBTI+ intervention sessions. A1=Baseline assessment; A2=Post-intervention assessment; A3=1-month post-intervention assessment; CI=confidence interval; d=Cohen’s effect size. α=Cronbach alphas calculated for current sample; Effect sizes for mindfulness and symptom self-efficacy are negative because higher values indicate higher mindfulness and/or symptom self-efficacy.

Discussion

In this study we adapted and piloted tested the feasibility and acceptability of a mindfulness-based insomnia and symptom management intervention (MBTI+) for patients with hematologic cancer. To our knowledge, this is the first mindfulness-based, behavioral intervention designed to address concurrent insomnia symptoms and fatigue, pain, and distress reported by hematologic cancer patients during treatment. MBTI+ exceeded feasibility and acceptability benchmarks, and exploratory estimates suggest that participants greatly improved from baseline to post-intervention on insomnia symptom severity (primary outcome) as well as secondary outcomes (i.e., fatigue, pain, anxiety and depressive symptoms, pre-sleep arousal, mindfulness, symptom management self-efficacy).

Patient and clinician feedback on the MBTI+ protocol was positive. Key suggestions guided adaptation of the intervention content, and led to two particularly innovative features. First, mindfulness principles (e.g., awareness) and meditations were emphasized as tools to distinguish fatigue from sleepiness. By practicing sitting and body scan meditations, for example, participants can bring present-moment, non-judgmental awareness to sensations in the body that might signal fatigue (e.g., lethargy) or sleepiness (e.g., dozing). Participants were encouraged to use sleepiness to guide sleep reconditioning (i.e., stimulus control) and napping, which may be necessary during intensive cancer treatment. Conversely, behavioral symptom coping techniques (e.g., activity-rest cycle, pleasant activity planning) were added to help participants increase their level and range of physical and/or pleasant activities to better manage fatigue and build sleep drive during the day to improve sleep quality at night.

Second, many patients and clinicians reported needing insomnia and symptom management during hospitalization. As such, discussion of how to use mindfulness meditations and insomnia and symptom management skills while inpatient was added to each session. Participants could practice mindfulness meditations in the hospital using the mp3 player or study website. It was also recommended that participants keep time-in-bed schedule as consistent as possible, and practice stimulus control by getting out of the hospital bed during the day. Likewise, use of the activity-rest cycle and pleasant activity planning skills was encouraged to maintain activity level, build sleep drive, and distract from the challenging hospital environment. This is an especially novel aspect of the MBTI+ intervention and is a first step towards comprehensive insomnia and sleep management support in the outpatient, as well as inpatient treatment setting where sleep is notoriously poor.

MBTI+ demonstrated strong feasibility and acceptability. Retention was excellent, as only 3 participants did not complete the post-intervention assessment. Nearly 90% of participants completed half or more of the intervention; this adherence rate is noteworthy given these patients experience a rigorous treatment course and significant symptom burden. MBTI+ was delivered individually via Zoom and the protocol allowed for flexible scheduling (i.e., sessions every 2–3 weeks, if needed). These features were endorsed during focus groups, and likely improved retention rates during user testing and the single-arm pilot since participants could attend sessions from wherever was convenient (home or hospital) and at a cadence that aligned with ongoing treatment. Similar procedures should be considered for future symptom management interventions in hematologic cancer. Participants found MBTI+ to be acceptable with the mean rating reflecting “high” satisfaction. Strong accrual, protocol adherence, and acceptability indicate the recruitment and assessment procedures are feasible, and MBTI+ material is applicable and helpful to this vulnerable population.

Descriptive statistics show that participants improved on insomnia symptom severity (primary outcome). In fact, the average ISI score decreased by more than 50% from baseline to post-intervention, and continued to decrease at 1-month post-intervention. Secondary outcomes of fatigue, pain, anxiety and depressive symptoms, pre-sleep arousal, mindfulness, and symptom management self-efficacy also improved from baseline to post-intervention, with some outcomes (e.g., pain, anxiety, depressive symptoms) decreasing even further by 1-month post-intervention. It is encouraging that effects on insomnia symptom severity, pain, and distress appear to persist and/or strengthen over time. Traditional MBTI has demonstrated large treatment effects in healthy outpatients (Ong et al., 2014; Perini et al., 2023), but this is the first study to show the promise of a novel mindfulness-based insomnia and multi-symptom management intervention, adapted specifically for patients with life-threatening hematologic cancer.

Study limitations warrant consideration. There was only one clinician focus group, and sample size across both patient and clinician focus groups was relatively small. Future development work (e.g., focus groups, interviews) might consider a larger sample with more demographically and medically diverse participants. Average insomnia symptom severity at consent fell within the “subthreshold” range. Future work should consider enrolling those with at least “moderate” insomnia symptom severity, as these individuals might benefit more from MBTI+. Still, since the average patient endorsed insomnia symptom severity consistent with a subthreshold condition, MBTI+ could represent an opportunity to prevent the onset of clinical insomnia disorder. Insomnia symptom severity was based on self-report; objective measurement of insomnia (e.g., actigraphy) and sleep parameters (e.g., sleep efficiency [SE], sleep onset latency [SOL], wake after sleep onset [WASO]) should be included in future trials. Finally, effect size estimates should be interpreted cautiously given the lack of control group. Symptom improvements could be due, in part, to more time since diagnosis.

Insomnia is a 24-hour disorder, with daytime consequences of nighttime sleeplessness cited as particularly bothersome. MBTI+ is innovative in that it encourages mindfulness to increase awareness of symptoms, and integrates training in behavioral insomnia strategies, with skills for managing daytime symptoms in the outpatient and inpatient setting. Next steps include testing the MBTI+ protocol in a larger randomized controlled trial that allows for more rigorous assessment of intervention mechanisms (e.g., pre-sleep arousal, mindfulness), moderators (e.g., sex, race/ethnicity), and effects on medication use (e.g., sedative hypnotics). Future trials might also consider formally testing components of the intervention in the inpatient setting to inform comprehensive insomnia and symptom management that is responsive to the challenging treatment and symptom burden experienced by hematologic cancer patients.

Appendix

Focus Group Guide - Patient

Total time: 60–75 minutes with a 5 minute break

A. Introduction (5 minutes)

• Introduce the purpose of the group

• Thank the participants for their assistance with the project

• Review group rules regarding confidentiality

• Answer any questions participants may have about the group

Welcome! We appreciate your willingness to participate in this group. Your feedback and the information you provide will help us to develop a program designed for patients who have undergone treatment for hematologic cancer. We are going to ask you questions about your experiences with your cancer diagnosis and treatment, as well as bothersome nighttime and daytime symptoms. Remember, there are no right or wrong answers, and the information you provide may benefit to other patients with hematologic cancer in the future.

We would like to start by reviewing a few group rules. We would like to get as many different opinions as possible during today’s session. We ask that you all participate and allow each other to have an opportunity to speak. We hope that today’s group will work like a discussion, so you do not need to be called on to speak; however, please be respectful of others who would like to contribute. Your privacy is important to us. While we as the study staff will make every effort to keep the information you provide to us confidential, we also need to request that you do not share information provided by your fellow group members outside of this group. Do you all agree to the previous requests? [Obtain a verbal yes from participants].

Our conversation today will be audio recorded and transcribed for review by Dr. Fisher to help develop the intervention. The transcript will not include information that could directly identify you, such as your name. You will be assigned a unique identification number. The audio recording will be destroyed once the study is complete. [Obtain a verbal yes from participants to record; START RECORDING].

Our conversation today will last for approximately 60–75 minutes. What you choose to share with the group is completely up to you. We will take a break about half way through the group to give you an opportunity to stretch your legs, go to the restroom, etc. If you need to leave for any reason prior to our break, please let us know.

Before we start, I want to share some helpful tips regarding Zoom:

• If possible, please leave your camera on for the entire focus groups. If you leave the focus group to use the restroom etc., please turn off you video.

• Please mute yourself when you are not talking to reduce background noise. Please also mute yourself if you leave the focus group to use the restroom etc.

• When you wish to talk, please unmute yourself.

• You may use the “Chat” function to communicate privately with me, or with the entire group. My colleague, Shannon, will also be typing questions and relevant commentary in the Chat box.

• If you have a question, you may alert me through the chart, use the “Raise your Hand” function on Zoom, or simply raise your hand in real time.

Do you have any questions about your participation in this focus group or about the project before we begin? [Answer questions as appropriate].

B. Ice Breaker (10 minutes)

Let’s take a few minutes to get to know each other. Please tell me your…

• Name

• Where you are from

• Your cancer diagnosis, when you were diagnosed, and where you are in your treatment course (i.e., cycle, inpatient hospitalizations etc.)

• “Rose, Thorn, and Bud”

C. Intervention (35 minutes)

Given the prevalence of bothersome physical and psychological symptoms experienced by patients with hematologic cancer after inpatient treatment, we are working to develop a mindfulness and cognitive-behavioral symptom management intervention that targets nighttime symptoms of insomnia and daytime symptoms of fatigue, pain, and stress. We anticipate that this intervention will be delivered one-on-one with a study therapist via videoconferencing.

We want to get your thoughts on the utility of a program like this.

Solicit participants’ feedback regarding handouts:

• We would like to show you the participant handouts we have been working to develop for this intervention. [Show handouts]. What feedback do you have for us?

  • How helpful do you think this content is? What is less helpful?
• What do you think about the coping skills included in this protocol?

  • How do you feel about the mindfulness exercises?
  • Do you have any concerns about any of the skills proposed for this intervention? [Probe about familiarity with mindfulness, comfort level with mindfulness concepts, exercises etc.]

• Are there things that are not included here that you wish you had known when going through inpatient treatment that you recommend we add?

• Participants will be provided with a binder with printed copies of study sessions handouts. These handouts will also be sent to participants as a PDF file via email. These handouts will allow participants follow along with study content during their session and review study content on their own outside of sessions. How does this sound to you? Helpful? Not helpful?

  • Do you have any suggestions regarding this part of the proposed intervention?

Solicit participants’ feedback regarding intervention structure, delivery modality etc.:

• Sessions will be completed over a 6–10 week period, leaving time for rescheduling, missed appointments etc. There will be 6 session total. How does that sound to you?

  • Do you feel that 6 sessions is too many? Not enough? Just right?

• Sessions will be approximately 60–75 minutes long. What do you think about this session length? Too long? Not long enough? Just right?

• What do you think would be the best way to receive this intervention? In-person? Via phone? Via videoconferencing (e.g., Zoom)?

  • What are some advantages and disadvantages of these different approaches?
  • What challenges are you having and/or do you anticipate having using videoconferencing platforms like Zoom?
  • What preferences do you have related to use of videoconferencing for sessions from home?

    • Would you need to borrow a device (e.g., iPhone, iPad) that is capable of videoconferencing?

Solicit participants’ feedback regarding anticipated barriers to intervention:

• What do you think are some barriers participants might experience when trying to complete this intervention?

  • How could we address these barriers?

Solicit participants’ feedback regarding most/least helpful aspects of intervention:

• What do you think are the most helpful parts of this intervention?

• What do you think are the least helpful parts of this intervention?

• What general suggestions do you have for us as we work to develop this intervention?

Solicit participants’ feedback regarding mp3 player:

• Participants will be provided with an mp3 player with audio recordings of the mindfulness and relaxation exercises learned during study sessions. This mp3 player is intended to help participants practice these techniques at home. Participants will be allowed to keep this mp3 player after completing the study. How does this sound to you? Helpful? Not helpful?

  • Do you have any suggestions regarding this part of the proposed intervention?

Solicit participants’ feedback regarding daily sleep diaries:

• Participants will be asked to complete daily sleep diaries across the 6 sessions of the intervention. These sleep diaries include 8 questions about the participant’s sleep the night before. These sleep diaries will be sent to participants via email as a link to a RedCap survey. How does this sound to you?

  • Is there another (better) way that these diaries could be administered?
• We would like to show you the items included in a sleep diary. Let’s take some time to walk through a sleep diary together. [Show sleep diary]. What feedback do you have for us?

  • Is there anything about this sleep diary that is difficult to understanding?

• How do you think it would be to fill this out every day?

• What would be the best way to collect this? Via email? Via text? Paper forms?

• What barriers, if any, might someone experience to completing a daily sleep diary?

  • How could we address these barriers?

D. Nighttime and Daytime Physical and Psychological Symptoms (20 minutes)

Ask participants about their experiences with insomnia (i.e., difficulty falling asleep, staying asleep, and/or waking up too early).

• Tell me about your experiences with poor sleep quality (i.e., difficulty falling asleep, staying asleep, and/or waking up too early) since your diagnosis and treatment.

  • When did this start? Before/after diagnosis? Before/after inpatient treatment?
  • Has your sleep quality changed since your diagnosis and treatment? Improved? Worsened?

• How has poor sleep quality impacted your ability to engage in activities in the way you would like? In what way?

Ask participants about their experience with fatigue and pain.

• Tell me about your experiences with fatigue since your diagnosis and treatment.

  • When did this start? Before/after diagnosis? Before/after inpatient treatment?
  • Has your fatigue level changed since your diagnosis and treatment? Improved? Worsened?
• Tell me about your experiences with pain since your diagnosis and treatment.

  • When did this start? Before/after diagnosis? Before/after inpatient treatment?
  • Where is your pain located, and what is the intensity of your pain on a scale from 0–10, with 10 being the most severe pain?
  • Has your pain level changed since your diagnosis and treatment? Improved? Worsened?

• How have your fatigue and/or pain impacted your ability to engage in activities in the way you would like? In what way?

Ask participants about their experience with stress.

• Tell me about your experiences with stress since your diagnosis and treatment?

  • What is (are) the primary source(s) of your stress?
  • When did this start? Before/after diagnosis? Before/after inpatient treatment?
  • Has your stress level changed since your diagnosis and treatment? Improved? Worsened?

• How has stress impacted your ability to engage in activities in the way you would like? In what way?

Note: Participants may bring up additional symptoms like cognitive problems, infertility, etc. Discuss these symptoms as appropriate.

Ask participants about how these symptoms influence each other:

• How does poor sleep at night influence how you feel during the day?

• How does fatigue, pain, and stress during the day influence your sleep quality at night?

Note: During the discussion, work to normalize participants’ symptoms and discuss similarities/commonalities noted between participants’ experiences. If participants’ express disparate symptom experiences, normalize this as well and acknowledge that symptom experiences may be treatment dependent as well as dependent on a number of different factors.

Ask about participants’ experiences with managing symptoms:

• What have you tried for managing poor sleep at night and fatigue, pain, and stress during the day?

  • What have you found to be helpful or not helpful for managing these symptoms?
• Has your healthcare team made any recommendations for managing poor sleep quality at night and fatigue, pain, and stress during the day?

  • If so, what have they suggested? Medications? Non-medication strategies?

• How useful have these techniques (both those recommended by the healthcare team and those you have found on your own) been at allowing you to better manage these symptoms and reduce their interference with important life areas?

Note: If a participant expresses very high symptom burden, suggest participants communicate with members of their medical team about these symptoms as appropriate.

E. Closing (1 minute)

Thank you so much for the information that you have provided. This will help us to create an intervention that is useful and relevant to patients with hematologic cancer. If you have any additional questions, please do not hesitate to contact us.

Focus Group Guide - Clinician

Total time: 60–75 minutes with a 5 minute break

A. Introduction (5 minutes)

• Introduce the purpose of the group

• Thank the providers for their assistance with the project

• Review group rules regarding confidentiality

• Answer any questions the providers may have about the group

Welcome! We appreciate your willingness to participate in this group. Your feedback and the information you provide will help us to develop a program designed for patients who have undergone treatment for hematologic cancer. We are going to ask you questions about the inpatient treatment experience for patients with hematologic cancer, as well as bothersome nighttime and daytime symptoms these patients might experience after inpatient treatment. Remember, there are no right or wrong answers, and the information you provide may benefit to patients with hematologic cancer in the future.

We would like to start by reviewing a few group rules. We would like to get as many different opinions as possible during today’s session. We ask that you all participate and allow each other to have an opportunity to speak. We hope that today’s group will work like a discussion, so you do not need to be called on to speak; however, please be respectful of others who would like to contribute. Your privacy is important to us. While we as the study staff will make every effort to keep the information you provide to us confidential, we also need to request that you do not share information provided by your fellow group members outside of this group. Do you all agree to the previous requests? [Obtain a verbal yes from participants].

Our conversation today will be audio recorded and transcribed for review by Dr. Fisher and the study team to help develop the intervention. The transcript will not include information that could directly identify you, such as your name. You will be assigned a unique identification number. The audio recording will be destroyed once the study is complete. [Obtain a verbal yes from participants to record; START RECORDING].

Our conversation today will last for approximately 60 minutes. What you choose to share with the group is completely up to you. We will take a break about half way through the group to give you an opportunity to stretch your legs, go to the restroom, etc. If you need to leave for any reason prior to our break, please let us know.

We thank you for taking the time to speak with us today. Before we get started, are there any questions about your participation in this focus group or about the project? [Answer questions as appropriate].

B. Nighttime and Daytime Physical and Psychological Symptoms (15 minutes)

We would like to learn more about the hematologic cancer diagnosis and treatment experience. Specifically, we would like to learn more about the bothersome nighttime and daytime physical and psychological symptoms that patients with hematologic cancer experience during and after inpatient treatment.

Ask providers about nighttime symptoms of insomnia (i.e., difficulty falling asleep, staying asleep, and waking up too early) in patients with hematologic cancer who have undergone inpatient treatment.

• Can you talk about your observations (if any) of nighttime symptoms of insomnia in patients with hematologic cancer during and/or after inpatient treatment?

  • Do these patients report nighttime symptoms of insomnia?

• Do patients with hematologic cancer complain about symptoms of insomnia interfering with their ability to engage in daily activities?

Ask providers about daytime symptoms of fatigue and pain in patients with hematologic cancer who have undergone inpatient treatment.

• Can you talk about your observations (if any) of daytime symptoms of fatigue in patients with hematologic cancer during and/or after inpatient treatment?

• Can you talk about your observations (if any) of daytime symptoms of pain in patients with hematologic cancer during and/or after inpatient treatment?

• Do patients with hematologic cancer complain about symptoms of fatigue and pain interfering with their ability to engage in daily activities?

Ask providers about daytime symptoms of stress in patients with hematologic cancer who have undergone inpatient treatment.

• Can you talk about your observations (if any) of daytime symptoms of stress in patients with hematologic cancer during and/or after inpatient treatment?

• What do you think are the primary source(s) of patients’ stress?

• Do patients with hematologic cancer complain about symptoms of stress interfering with their ability to engage in daily activities?

Note: Providers may bring up additional symptoms like cognitive problems, infertility, etc. Discuss these symptoms as appropriate.

Ask providers about how these symptoms influence each other:

• Please tell us about how nighttime symptoms of insomnia might influence daytime symptoms of fatigue, pain, and stress (and vice versa).

Ask providers about symptom trajectory in terms of severity and interference:

• In your experience, how do nighttime symptoms of insomnia influence daytime symptoms of fatigue, pain, and stress (i.e., severity and interference) change over time during and after inpatient treatment?

Ask providers about management of nighttime (i.e., insomnia) and daytime (i.e., fatigue, pain, and stress) symptoms:

• What approaches do you typically recommend to patients for managing nighttime (e.g. insomnia) and daytime (e.g., fatigue, pain, and stress) symptoms?

  • What about medications?
  • What strategies are requested by the patients themselves?

• What have you found is the most helpful for managing nighttime (i.e., insomnia) and daytime (e.g., fatigue, pain, and stress) symptoms?

• What have you found is the least helpful for managing nighttime (i.e., insomnia) and daytime (i.e., fatigue, pain, and stress) symptoms?

D. Intervention (35 minutes)

Given the prevalence of physical and psychological symptoms experienced by patients with hematologic cancer, we are working to develop a mindfulness and cognitive-behavioral symptom management intervention that targets nighttime symptoms of insomnia and daytime symptoms of fatigue, pain, and stress.

We have already met with patients with hematologic cancer to get their feedback, and now want to get your thoughts on the utility of a program like this.

Solicit providers’ feedback regarding handouts:

• We would like to show you the participant handouts we have been working to develop for this intervention. [Show handouts]. What feedback do you have for us?

  • How helpful do you think this content is? What is less helpful?

• Are there things that are not included here that you think patients undergoing inpatient treatment would benefit from that you recommend we add?

• What do you think about the coping skills included in this protocol?

  • How do you feel about the mindfulness meditations?
  • Do you have any concerns about any of the skills proposed for this intervention? [Probe about familiarity with mindfulness, comfort level with mindfulness concepts, exercises etc.]
• Participants will be provided with a binder with printed copies of study sessions handouts. These handouts will also be sent to participants as a PDF file via email. These handouts are intended to help participants follow along with study content during their session with their therapist and review study content on their own outside of study sessions. How does this sound to you?

  • Do you have any suggestions regarding this part of the proposed intervention?

Solicit providers’ feedback regarding intervention structure, delivery modality etc.:

• What do you think about the number of sessions (6)? Sessions will be completed over a 6–10 week period, leaving time for rescheduling, missed appointments etc.

  • Do you feel that 6 sessions is too many? Not enough? Just right?

• Sessions will be approximately 60–75 minutes long. What do you think about this session length? Too long? Not long enough? Just right?

• What do you think would be the best way to receive this intervention? In-person? Via phone? Via videoconferencing (e.g., Zoom)?

  • What challenges (if any) do you anticipate patients might have using videoconferencing (i.e., Zoom)?

Solicit providers’ feedback regarding anticipated barriers to intervention:

• What do you think are some barriers participants might experience when trying to complete this intervention?

  • How could we address these barriers?

Solicit providers’ feedback regarding most/least helpful aspects of intervention:

• What do you think are the most helpful parts of this intervention?

• What do you think are the least helpful parts of this intervention?

• How would a study like this help you (if at all)? Will it save you any time, effort etc.?

• Do you see there being incentive to you to have a study like this ongoing in the clinic?

• How can we make this intervention practical and transferrable to the clinical setting? How can we make it sustainable?

• What general suggestions do you have for us as we work to develop this intervention?

E. Closing (1 minute)

Thank you so much for the information that you have provided. This will help us to create an intervention that is useful and relevant to patients with hematologic cancer. If you have any additional questions, please do not hesitate to contact us.