A Pragmatic Randomized Controlled Pilot Trial of Brief Meaning Centered Psychotherapy in Homecare

Abstract

Introduction:

Individuals with advanced cancer receiving homecare experience elevated psychosocial and existential distress, yet few interventions address these concerns. This pilot randomized controlled trial (RCT) examined the feasibility, acceptability, and preliminary efficacy of brief, nurse-delivered Meaning-Centered Psychotherapy in patients with advanced cancer compared to Treatment As Usual (TAU).

Methods:

Distressed patients (age ≥18) were randomized 1:1 to 3-session Meaning-Centered Psychotherapy for Hospitals, Hospice, and Home (MCP-H) (n=33) or TAU (n=32). Feasibility was based on recruitment, retention, data completion, fidelity, and intervention engagement. Acceptability was based on patients’ and nurses’ ratings of MCP-H satisfaction. Preliminary efficacy was determined by changes in scores from baseline to 6 and 10 weeks in meaning and secondary outcomes using between group-analysis.

Results:

Seventy-one patients enrolled. Feasibility was demonstrated by satisfactory recruitment (75% approach-to-consent rate; 92% enroll-to-randomize rate), retention (74% and 75% at T2 and T3, respectively), intervention engagement (94% completed 100% of the sessions), and treatment adherence (87% mean rating). Participants endorsed the intervention’s acceptability (96% satisfied or very satisfied). MCP-H participants experienced improvements in meaning (d=0.39 at T2; d=0.30 at T3) and most other secondary psychosocial outcomes at 6 and 10 weeks compared to TAU participants.

Conclusion:

MCP-H is feasible and acceptable among patients with advanced cancer in homecare. This intervention demonstrated promising evidence of clinical efficacy. A larger, fully powered RCT is needed to test the efficacy of the intervention for patients, nurses, and health system outcomes against an active control group.

Précis:

Meaning Centered Psychotherapy at Home (MCP-H) is a brief intervention with demonstrated feasibility, acceptability, and preliminary effects on meaning and other important psychosocial outcomes when delivered by nurses to individuals with cancer receiving home health care. The results of this pilot RCT provide a strong signal to conduct a fully powered RCT of MCP-H to determine its efficacy.

Introduction

Patients with serious illness such as advanced cancer are often confronted with existential distress that exacerbates anxiety and depression and, when unaddressed, may lead to increased suffering and despair.^1–4 Existential distress is conceptualized as feelings of hopelessness, demoralization, loss of personal meaning and dignity, desire for death or the decreased will to continue living.^1–3 Homebound individuals and their families face compounded existential concerns and loss of meaning above and beyond ambulatory patients with advanced illnesses, as they contend with an even greater loss of independence and declining opportunities for activities and social engagement.^5–14 Frontline clinicians are often faced with expressions of existential suffering and despair in their patients’ dealing with chronic, life-limiting illness. However, few clinicians are trained to address these concerns and must navigate such encounters with minimal guidance and support. Meaning Centered Psychotherapy (MCP),^15–19 an empirically supported psychotherapeutic intervention with clinically significant efficacy in ameliorating existential distress and a loss of meaning, was developed in response to this need.

To date, four randomized controlled trials (RCTs) have examined the efficacy of 7 (i.e., individual) or 8 (i.e., group) session MCP in patients with advanced cancer.^15–19Additionally, our NCI-funded training program to disseminate MCP has trained over 695 professionals, highlighting the demand for training to help seriously ill patients face prolonged physical and existential suffering.^20–21 However, clinicians consistently report barriers to implementing the full MCP intervention in their practice, including that the length and structure of the intervention is overly burdensome for patients who have more severe or acute illnesses.²¹

In response to implementation challenges, we developed an abbreviated version of MCP for palliative care as a brief, practical alternative for community practice. We consolidated the material from the full 7 session individualized MCP treatment manual, reduced the number of sessions to 3, and reduced session length from one hour to approximately 30–45 minutes. We previously conducted a preliminary, single-arm feasibility study in a hospice setting to refine the 3-session treatment manual and assess the acceptability of brief MCP. The results were positive and supported further study of brief MCP in the current trial.^19,22

For the present study, the brief MCP manual was further adapted for patients with advanced cancer in homecare (MCP Hospital, Hospice, Home, or MCP-H). Homecare agencies provide care to over 4.5 million patients annually, with nurses comprising over half of their employees.⁶ Given the size of this growing workforce and their frequent contact with homebound patients, they are in a unique position to deliver evidence-based interventions to reach some of the nation’s most vulnerable and underserved patients. To date, MCP research trials have only trained mental health professionals to deliver MCP through tertiary care cancer centers. Therefore, the feasibility and acceptability of MCP delivered by other types of healthcare professionals needed to be determined, as did the impact of the abbreviated, 3-sessions version on psychosocial outcomes.

The purpose of this pilot study was to: (1) evaluate the feasibility and acceptability of nurse-delivered MCP-H in an RCT; and (2) assess the preliminary effects of nurse-delivered MCP-H compared to treatment as usual (TAU) on patients’ spiritual well-being, psychological distress, QOL, pain, and end of life despair. This pragmatic trial enhances the ecological validity of previous MCP RCTs by training homecare nurses to deliver brief MCP-H in the community, thus enhancing its potential for widespread implementation.

Materials and Methods

Participants

Nurse interventionists were (1) ≥18 years old, (2) fluent in English, and (3) providing direct care services through Visiting Nurse Service Health (VNS Health). Nurses were excluded if they planned to leave their position at VNS Health in the next 6 months at the time of consent.

Eligible patient participants were ≥18 years old who (1) were a patient in the VNS Health certified home health agency (CHHA), (2) had a cancer diagnosis and a rating of ≥ 2 on the Symptom Control Scale which indicates symptoms are controlled with difficulty or unable to be controlled,²³ (3) were fluent in English, (4) had a score of ≥ 4 on the Callahan cognitive screener²⁴ indicating intact cognition, and (5) had a score of ≥ 4 on the Distress Thermometer²⁵ (indicating moderate psychological distress). Participants were excluded if they (1) had a diagnosis of Alzheimer’s dementia, or other organic brain disorder and in the judgment of study personnel was unable to meaningfully participate in the study, (2) had impaired decision-making capacity, (3) were permanently placed in a nursing home, or (4) were receiving hospice care.

Procedures

This study was approved by Memorial Sloan Kettering Cancer Center (MSK), who served as the IRB of record (22–019), and VNS Health (CE22–002). The trial is registered with clinicaltrials.gov (NCT05495737).

Nurse interventionists were recruited at VNS Health through multiple outreach methods including a distribution of a recruitment email to clinical teams, manager identification of potential participants, and advertisement of opportunity on the home healthcare organization’s internal social media. Interested candidates were provided with a more detailed description of the study by the collaborating study staff at VNS Health. Permission to share names and contact information from those who continued to express interest was secured and passed along to MSK research staff for the formal consenting process.

Enrolled nurses completed a two-day virtual training in MCP-H that focused on acquisition of intervention skills through role play practice with professional actors. Prior to seeing RCT participants, nurses completed one training case with a VNS patient and received feedback and supervision from the study investigators. Throughout the trial, nurses also received bi-weekly videoconference clinical supervision in MCP-H from the study investigators (clinical psychologists).

Participants were recruited from the VNS Health CHHA. Homebound patients are served in a CHHA when there is a need for short-term, intermittent skilled clinician (e.g., nursing, physical therapy) services to help with recovery after a hospitalization or to help stabilize someone dealing with a chronic condition. CHHA plan of care will differ depending on patient need but may include services, such as, wound care, catheter care, rehabilitation services, medication management. VNS research staff first identified potential patient participants by reviewing a list of potential participants generated using the VNS home health program data. Once VNS staff spoke with potential participants and conducted eligibility screening (including permission to release their information to MSK research staff), they were contacted by an MSK Clinical Research Coordinator (CRC) to hear more about the study and if interested, provide informed consent. Next, participants were invited to complete their baseline assessment (T1) via REDCap survey software before being randomized to one of the two groups. Participants were also offered the option to complete surveys with pen and paper or over the telephone with the CRC if they preferred. Participants also completed assessments immediately post-intervention (or 6 weeks post-baseline in TAU, T2), and one-month post-intervention completion (or 10 weeks post-baseline in TAU, T3). Participants received a $25 gift card for their time after each completed assessment.

Intervention

Participants randomized to the intervention arm received three sessions of MCP-H over the course of 3 to 6 weeks; sessions were delivered by telephone or videoconferencing based on patient preference. MCP-H was specifically developed for patients with advanced cancer in acute care settings. Based on the principles of Viktor Frankl’s Logotherapy^26–28, MCP-H was adapted from extensive research on MCP with advanced cancer patients in an outpatient setting.^15–18 The approach focuses on developing and bolstering a sense of meaning and purpose in life despite the limitation, challenges, and losses faced because of illness and physical limitations. Session content from the original 7 session MCP was re-organized to focus on the most essential material early in each session (see Table 1). Each session is approximately 30–45 minutes.

Table 1.

Meaning-Centered Psychotherapy for Hospitals, Hospice, and Home (MCP-H)

Session	MCP-H Topics	Content Overview
1	Experiencing Meaning	Introduction to the Concept of Meaning & Sources of Meaning Meaningful Moments Exercise Identity – Before & After Cancer Diagnosis Historical Sources of Meaning – Memories, Relationships & Traditions
2	Choosing and Creating Meaning	Encountering Life’s Limitations – Attitude Limitations, Losses, Obstacles Faced in the Past Choosing Our Attitude in the Present Creativity and Courage - Moments of Courage, Ownership & Commitment
3	Maintaining Meaning	Connecting with Life Through Experiences - Love, Beauty, Humor Living Fully Now - Unfinished Business, Realistic Feasible Goals or Wishes The Legacy You Give Using the Sources of Meaning Going Forward Reflecting on Meaning and Sessions

Treatment As Usual

Participants randomized to TAU received what would normally be part of discharge planning for patients endorsing high levels of distress at VNS Health. This included targeted referrals based on individual patient needs as suggested by Reynolds and colleagues²⁹, including appropriate local referrals for psychosocial care.

Measures

RCT and MCP-H feasibility and acceptability were evaluated using several indicators with a priori benchmarks (Table 2) based on past pilot RCTs in oncology.³⁰

Table 2.

Acceptability and Feasibility Benchmarks

Metrics	Benchmark	Result
Feasibility
Recruitment	≥70% approach-to-eligible rate ≥70% eligible-to-consent rate ≥70% randomize-to-consent rate	71% (95/134) 75% (71/95) 92% (65/71)
Intervention Engagement	≥75% complete 3 MCP-H sessions	94% (31/33)
Retention/Assessment Completion	≥75% baseline completion during T1 ≥75% follow-up surveys during T2 ≥75% follow-up surveys during T3	65/71 (92%) 48/60 (80%)* 50/65 (77%)
Treatment Adherence	≥80% mean adherence rating across cases	10.46/12 (87%)
Acceptability
Nurse Satisfaction (Acceptability)	≥80% will endorse a mean score of ≥33 on the MCP-H /Attitude Assessment	100% (18/18)
Patient Satisfaction (Acceptability)	Mean score of ≥18 on the Patient MCP-H Satisfaction Questionnaire	96% (24/25)

^*Five T2 assessments were not sent to participants due to an administrative error.

While feasibility and acceptability were the primary outcomes of this study, preliminary treatment effects were also evaluated. The primary outcome of interest was meaning as measured by the FACIT Spiritual Wellbeing Scale (SWB) Meaning subscale, which has demonstrated reliability and validity as a measure of meaning and spiritual wellbeing among patients with cancer and other chronic illnesses.³¹ The FACIT SWB scale is a 12-item self-report measure designed to assess the nature and extent of an individual’s spiritual well-being that generates two subscales (Faith and Meaning/Peace) and a total score (range 0–48). The Faith subscale of the SWB was evaluated as a secondary outcome.

Additional secondary outcome measures included: 1) anxiety and depression using the Hospital Anxiety and Depression Scale, a 14-item scale with depression and anxiety subscales of seven items each (total score range = 0–42; each subscale total score ranges from 0–21)³²; 2) hopelessness using the Hopelessness Assessment in Illness scale³³, a 8-item questionnaire specifically developed to assess hopelessness in cancer patients with advanced disease and terminal illness (total score range 0–16); 3) death acceptance using the Schedule of Attitudes toward Hastened Death^34–36, a 20-item questionnaire (range 0–20) measure of interest in hastened death; 4) quality of life using the McGill Quality of Life Questionnaire³⁷, a 17-item, self-report instrument designed to assess various domains of psychological, spiritual, and physical functioning among terminally ill patients (total score range = 0–10); 5) pain using the PEG Scale Assessing Pain Intensity and Interference³⁸, a 3-item scale used to track an individual’s changes over time with regard to experience of pain, and the impact that pain has had on enjoyment of life and general activity, ranging from 0 to 10; 6) MCP-H satisfaction, a 6-item questionnaire (rated 1–5) that asks the patient to assess their overall satisfaction with MCP-H and to rate the clinician on MCP core competencies (MCP-H participants only); 7) therapeutic alliance using the Working Alliance Inventory- Short Form- Client³⁹, a 12-item multidimensional scale of therapeutic alliance with scores ranging from 12 to 84 (MCP-H patients only, with 7-point Likert scale); and 8) utilization of resources using the Resource Utilization form regarding utilization of any of the resources or referrals provided to patients in order to better characterize usual care and service utilization (TAU participants only).

Nurse interventionists also completed brief surveys throughout the study. Upon consenting, they completed a brief sociodemographic and Professional Experience Questionnaire. After completion of each case during the RCT, nurses also completed the MCP-H Perception/Attitude Assessment. This 11-item instrument asked nurses about their perceptions of the feasibility and acceptability of MCP-H implementation. Items are rated from 1 to 4 (total score range is 11–44; threshold score for success is 33 or greater).

Statistical Analysis

Nurse and patient characteristics are described, including nurse and patient demographics, nurse professional characteristics, and patient cancer type. Feasibility metrics were calculated and compared, descriptively, to a priori benchmarks. For acceptability, satisfaction questionnaires completed by both nurses and patients were summarized based on the percentage of respondents who endorsed the top two categories (e.g., ‘a lot’ and ‘very much’). Preliminary efficacy was assessed by calculating Cohen’s d for between-groups effects of change scores at each timepoint. We calculated change scores both based solely on complete cases and also employed a last-observation-carried-forward (LOCF) method, assuming no improvement when follow-up data are missing. All analyses were conducted in SAS version 9.4 (Cary, NC).

Results

Participant Characteristics

Nurses.

A total of 9 nurses completed MCP-H training, and 5 opted to stay on as study interventionists throughout the trial. Nurses had an average of 27 years of experience and an average of 20 years at VNS (see Table S1).

Patients.

Mean patient age was 68.8 years (Range 46–89) and most were female (78%; n=51; Table 3). Half of participants were White (48%; n=31) followed by 29% (n=19) Black or African American; 14% (n=9) identified as Hispanic. Thirty-one percent (n=20) of participants were married or partnered. There was a range of formal education attainment with 29% (n=19) having graduated college. Two thirds of participants were retired (66%; n=43) and slightly over half lived in a household earning $66,000 or less per year. Cancer history was heterogeneous with breast, colon/rectal, and lung/bronchus most represented. Thirty-three participants were randomized to MCP-H and 32 to TAU (N=65).

Table 3.

Patient baseline characteristics (N=65)

Characteristic	n (%)	Characteristic	n (%)
Gender		Relationship Status
Male	14 (22%)	Single	25 (38%)
Female	51 (78%)	Married/Partnered	20 (31%)
Race		Divorced/Separated	6 (9%)
White/Caucasian	31 (48%)	Widow	13 (20%)
Black or AA	19 (29%)	Other or Missing	1 (2%)
Asian	3 (5%)	Annual Income
Multi-racial	4 (6%)	<$21k	16 (25%)
Other	4 (6%)	$21k - <$40k	9 (14%)
Refused or Missing	4 (6%)	$40k - <$66k	10 (15%)
Hispanic: Yes	9 (14%)	$66k - <$106k	9 (14%)
Education		$106k +	14 (22%)
Some HS	6 (9%)	Refused or Missing	7 (11%)
HS or GED	13 (20%)	Cancer Type
Some College or Trade	12 (18%)	Breast	20 (31%)
College Grad	19 (29%)	Colon/Rectum	6 (9%)
Some Post-Grad	3 (5%)	Lung & Bronchus	6 (9%)
Completed Post-Grad	12 (18%)	Other	30 (46%)
Employed: Yes	10 (15%)	Psych treatment: Yes	27 (42%)
Retired: Yes	43 (66%)
Age [n=64]		Arm: MCP-H	33 (51%)
M (SD)	68.8 (9.8)
Range	46 – 89

Feasibility

All recruitment feasibility benchmarks were exceeded (Table 2; see Figure S1 for CONSORT diagram). A mean of 3.9 participants were recruited per month between April 2023 and September 2024. Of the 909 potential participants who were medically eligible and screened by VNS, 48% did not meet further inclusion criteria, 37% were not interested in the study, and 15% (n=134) were potentially eligible and agreed to be contacted by MSK research staff. Of those expressing initial interest and willing to be screened, the approach-to-eligible rate was 71% (n=95/134), eligible-to-consent rate was 74.7% (n=71/95), and the consent-to-randomize rate was 92% (n=65/71).

Half of participants preferred to have their sessions via videoconference and half preferred telephone (16 v. 16). Retention was high for MCP session completion with 94% (31/33) of participants completing all three sessions. In parallel in the TAU arm, 81% (26/32) remained on the study through the T2 assessment. Assessment feasibility benchmarks were also exceeded with 92% (65/71) completing the T1, 80% (48/60¹) completing the T2, and 77% (50/65) completing the T3 assessment. In the TAU arm, 18% (n=4/22) of participants reported utilizing referrals at T2 and 18% at T3 (n=4/22; see Table S2 for a list of reported services).

The feasibility of training the nurse interventionists in this study was also demonstrated by high scores on the WAI at T2 (Mean=73.6; SD=12.9), indicating that MCP-H participants experienced strong therapeutic alliances with their nurse interventionists. A random sample of one session from each completed MCP-H case sessions (n=31) was reviewed by a research assistant to monitor treatment adherence. Ratings indicated close adherence to the treatment manual, with mean global ratings of 10.69 (on a scale of 0–12), or 87% adherence.

Among the patient participants who did not complete the study (n=15, 23% of total sample), 13 dropped before the T2 assessment and 2 dropped before the T3. Only 4 participants withdrew due to being too sick (n=3) or having competing demands (n=1), while 1 died and 10 were lost to follow-up (i.e., unknown reasons for attrition).

Acceptability

Patient participants endorsed high levels of acceptability of the intervention based on the MCP-H Satisfaction Questionnaire (Figure 1). The a priori acceptability benchmark was exceeded such that 96% (n=24) of 25 respondents had a total MCP-H Satisfaction score of at least 18. Additionally, 92% (n=23) of the sample were ‘a lot’ to ‘very much’ satisfied overall with MCP-H, 92% (n=23) found intervention materials to be easy to understand and follow, and 88% (n=22) felt that their therapist was ‘a lot’ to ‘very much’ comfortable teaching them about MCP-H and engaging them in the process.

Figure 1.

MCP-H Satisfaction Questionnaire

Nurse participants were also highly satisfied with their experiences as interventionists throughout the study. In 100% (n=18) of the rated interactions with MCP-H patients, nurses responded with ‘agree’ or ‘strongly agree’ that using MCP-H enhances the quality of nursing homecare and that they feel supported to provide MCP-H. All (100%; n=18) interactions were rated with a summary score of at least 33, well exceeding the benchmark of 80%.

Preliminary Efficacy

See Table 4 for mean scores for all measures at each time point. In between group analyses of the complete case analyses, the effect size on meaning (FACIT-M) was medium to large (d=0.59) from T1 to T2 and small to medium from T1 to T3 (d=0.39; Table 5). Effect sizes for all secondary outcomes were small to large, ranging from 0.29 on pain (PEG) to −0.73 on anxiety (HADS-A). Effects were maintained at the T3 assessment for anxiety (d=−0.51; HADS-A), QOL (d=0.30; MQOL), and desire for hastened death (d=−0.42; SAHD) but dissipated for other outcomes. The only outcome in which there was a larger effect for TAU than MCP-H was faith (FACIT-F), in which the effect was −0.39 at T2 and −0.30 at T3. Effect sizes calculated using the LOCF method were generally stronger than those calculated based on complete cases only.

Table 4.

Mean Scores for All Outcome measures Across Time Points

Measure	Baseline n=65	Post n=48	Final n=50
FACIT Spiritual	2.54 (0.9)	2.59 (0.8)	2.71 (0.9)
Faith	2.38 (1.3)	2.53 (1.1)	2.66 (1.1)
Meaning	2.62 (0.8)	2.62 (0.8)	2.74 (0.8)
HADS Anxiety	8.39 (4.2)	8.18 (4.1)	8.20 (4.2)
HADS Depression	7.37 (3.5)	6.63 (3.6)	6.22 (3.7)
HAI Hopelessness	4.80 (2.9)	4.42 (3.2)	4.46 (3.1)
SAHD	2.78 (3.4)	2.44 (3.0)	2.68 (3.1)
PEG Pain Scale	16.34 (8.4)	16.38 (8.3)	14.56 (8.1)
McGill QOL	77.35 (22.8)	77.46 (22.5)	81.14 (22.5)

Table 5.

Between-group (MCP-H vs. TAU) effects, Cohen’s d

	Post		Final
	CC (n=48)	LOCF (n=65)	CC (n=50)	LOCF (n=65)
FACIT-SWB	0.27	0.28	0.11	0.04
Faith	−0.39	−0.49	−0.30	−0.37
Meaning	0.59	0.68	0.39	0.34
HADS Anxiety	−0.73	−0.85	−0.51	−0.61
HADS Depression	−0.37	−0.41	−0.13	−0.11
HAI (Hopelessness)	−0.47	−0.53	−0.03	−0.08
McGill QOL	0.30	0.35	0.30	0.36
PEG (Pain)	0.29	0.34	0.15	0.18
SAHD	−0.51	−0.58	−0.42	−0.46

Note. CC = complete cases. LOCF= last-observation-carried-forward method. A positive Cohen’s d indicates the change score for MCP-H was greater than the change score for TAU (e.g., HADS Anxiety either decreased more for MCP-H or increased less, relative to the change for TAU). Sample sizes for each comparison may be slightly less than indicated for the column, due to some partially completed assessments.

Discussion

Existential despair and a loss of meaning and purpose are common among individuals with advanced cancer, especially those with a higher symptom burden such as those receiving homecare services. In the present pilot RCT, 3-session MCP-H demonstrated high feasibility and acceptability to both patients and nurse interventionists across all a priori metrics. Additionally, medium to large effects were observed for meaning and all secondary outcomes upon session completion. Many of these effects remained one-month post-intervention.

The excellent retention in this study likely reflects the unmet need for services like MCP-H among this hard-to-reach patient group. Participants had significant medical multimorbidity with frequent doctors’ visits, hospitalizations, and rigorous outpatient treatment programs and therefore 37% of initially approached potentially eligible participants declined. However, 95% of those who agreed to be contacted by MSK and met all eligibility criteria chose to participate in the study. Remarkably, 31 out of 33 participants completed all MCP-H sessions and assessment completion rates exceeded our benchmarks. These outcomes, along with participants’ high satisfaction and therapeutic alliance (i.e., relationship with interventionist) ratings, indicated that patients were pleased with the study procedures, intervention, and nurse interventionists. Moreover, this was the most diverse sample in any MCP RCT to date with respect to race and socioeconomic characteristics. Thus, MCP-H has demonstrated these key preliminary metrics in an appropriately heterogenous sample.

Nurse interventionists also demonstrated a strong ability to learn the MCP-H concepts and facilitate sessions with high adherence to the manual (i.e., treatment adherence ratings >87%), reinforcing the feasibility of disseminating this intervention to a wide range of multidisciplinary cancer care providers who care for acutely ill patients. Despite their high-volume caseloads and many competing demands, interventionists stayed active and engaged throughout the study. They also provided strong positive feedback on their experiences in weekly supervision and on their outcome assessments. Interventionist satisfaction in psychotherapy trials is often overlooked but is perhaps as important as patient satisfaction, otherwise clinicians will not use the treatment. MCP-H was designed with the end user in mind to facilitate its uptake and ease of integration in real world settings. With iterative feedback from interventionists throughout the trial, the MCP-H manual was prepared in a highly trainable, scalable format for future study and dissemination efforts. It is worth noting that the nurse interventionists in this trial were very experienced, and it might be more challenging for more novice clinicians. In a larger trial we can recruit a cadre of clinicians with a wider range of experience and evaluate whether or not it impacts patient outcomes.

The preliminary effects observed in this pilot RCT were also strong. The medium to large effect on meaning (SWB-M; d=.59) post-intervention and one month later (d=.39) is a signal that even a 3-session dose of MCP has the potential to have a clinically important and lasting effect on meaning and other important psychosocial outcomes such as anxiety, quality of life, and desire for hastened death, all of which were maintained one month post intervention. Only effects on the faith subscale of the FACIT were in an unexpected direction such that participants in the TAU arm experienced greater improvements in faith over time. Although MCP-H is a secular treatment, interventionists are encouraged to support and facilitate each patients’ connection to their faith, religiosity, or spirituality as a source of meaning as it arises. It is possible that in the absence of a program such as MCP-H, individuals facing life limiting illness turn to their faith as a form of coping. However, given our small sample size these effects need to be replicated in a fully powered sample before interpreting further. The preliminary effect sizes observed in this study did however exceed those found in our fully powered RCT of 7 session individual MCP compared to Enhanced Usual Care (EUC) which was analogous to the TAU control arm in this study. These effects provide support for a fully powered efficacy study where its true impact can be evaluated.

Limitations of the current pilot RCT include recruitment through a single home health agency in one urban geographic area which may limit its generalizability to other homecare agencies or regions. This was also a pilot RCT and therefore it was not powered for formal hypothesis testing and effect sizes should be interpreted with caution. Additionally, in this phase of the research the intervention was only delivered in English. The next larger trial of MCP-H will address these limitations by being fully powered and will include delivery in other languages as well.

This trial was a success largely due to the strong partnership established between MSK and VNS Health, leveraging each team’s complementary expertise. We worked closely with nurse scientists and leaders up front when developing the concept and scope of this MCP adaptation and trial design. To facilitate our nurse interventionists being able to fit the intervention into their clinical day, our VNS collaborators liaised with nurse managers to arrange for our nurse interventionists to have protected time to see cases for the RCT. We recognize the many competing demands placed on nurses and their limited time, and that in its current form, MCP-H would be challenging to add to existing workflows. Thus, as we determine efficacy in next steps we will also explore opportunities for future reimbursement and embedding this into routine episodes of care.

Conclusion

These pilot study results provide a strong signal regarding the feasibility, acceptability, and preliminary effects of MCP-H on meaning and other key psychosocial outcomes among homebound individuals with advanced cancer and can be used in other shorter term care settings such as the hospital or hospice. This study adds to the growing number of well conducted RCTs of MCP targeting the uniquely challenging domains of existential despair and even desire for hastened death, which many clinicians feel unprepared to navigate. Additionally, patients in the community such as those receiving homecare are not likely to receive the traditional 7 session MCP intervention due to challenges with its implementation. Therefore, 3 session MCP-H is a potentially viable option to increase the reach of this important intervention while streamlining its complexity and enhancing its accessibility. As noted, MCP-H may also be highly feasible to deliver in other settings where briefer interventions are needed (i.e., hospitals or hospice). Based on these findings, MCP-H warrants further investigation in a fully powered RCT.

Data availability:

The data that support the findings of this study are available from the corresponding author upon reasonable request.