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. Author manuscript; available in PMC: 2025 Feb 12.
Published in final edited form as: J Pain Symptom Manage. 2020 Feb 13;59(6):1260–1267. doi: 10.1016/j.jpainsymman.2020.02.004

Online Couple-Based Meditation Intervention for Patients with Primary or Metastatic Brain Tumors and their Partners: Results of a Pilot Randomized Controlled Trial

Kathrin Milbury 1, Shiao-Pei Weathers 1, Sania Durrani 1, Yisheng Li 1, Meagan Whisenant 1, Jing Li 1, Bora Lim 1, Jeffrey S Weinberg 1, Shelli Kesler 1, Lorenzo Cohen 1,*, Eduardo Bruera 1,*
PMCID: PMC11816621  NIHMSID: NIHMS1573468  PMID: 32061834

Abstract

Purpose:

Although patients with primary and metastatic brain tumors (BT) and their partners are at risk of experiencing high symptom burden, they are often excluded from psychosocial intervention studies. Thus, we sought to examine the feasibility and preliminary efficacy of a couple-based meditation (CBM) program targeting symptom and well-being outcomes.

Methods:

Couples completed baseline measures assessing symptom and well-being outcomes and were randomized to the CBM or a usual care control (UC) group. Couples in the CBM groups attended four, weekly (60 min. each) therapist-led sessions that were delivered via FaceTime. The CBM program focused on cultivating mindfulness, compassion, gratitude and purpose and integrated emotional disclosure exercises. Both groups were reassessed 6 and 12 weeks after baseline.

Results:

We approached 60 eligible dyads of which 37 (62%) consented and 35 (95%) were randomized and 22 (63%) completed all assessments. Couples in the CBM group attended a mean of 3.33 sessions (SD=1.09). For patients, significant group differences in favor of the CBM group were found for cognitive (d=1.05) and general disease symptoms (d=.93), and relationship well-being (d=.68) and compassion (d=.96). No significant group differences were revealed for partners.

Conclusions:

It seems to be feasible, acceptable and possibly efficacious to deliver a dyadic intervention via FaceTime to BT couples. Although both patients and partners in the CBM group rated the intervention as beneficial, significant group differences with medium to large effect sizes were only found for patients.

Keywords: Brain tumor, couples, videoconference, psychosocial intervention, meditation, caregivers, symptoms, quality of life

INTRODUCTION

Patients with brain tumors (BT), whether primary or metastatic, are at risk of high symptom burden, cognitive and neurological dysfunction, poor quality of life (QOL) and relatively short survival.1–5 Given BT patients’ high caregiving needs, it is not surprising that family caregivers, particularly spouses/partners, are vulnerable to anxiety and depressive symptoms possibly at even higher levels than BT patients.6 As patients enter the palliative care phase, partners may be at an increased risk of experiencing depressive symptoms and may lack the ability to provide effective and sensitive care.7 Thus, a couple-based supportive care approach may be beneficial to manage symptoms in both patients and partners during the palliative care phase.

Despite the high symptom burden and relatively high prevalence rates (e.g., brain metastases occur in 20% to 40% of cancer patients), evidence-based supportive care interventions for patients with primary or metastatic BT and their caregivers are generally lacking.8–12 Moreover, the dyadic psychosocial literature only includes a handful of trials targeting the needs of couples coping with advanced cancer.13–19 Building upon this existing evidence, we pilot-tested a 4-session dyadic program that integrates meditation training with emotional disclosure exercises. We chose a meditation-based approach because it has been suggested that mind-body interventions may improve cancer-related symptoms including cognitive dysfunction in patients with breast cancer.20–22 The emotional disclosure exercises were imbedded to target relationship well-being and informed by an existing couple-based intervention.23 Our primary goal was to examine the feasibility of implementing a randomized controlled trial (RCT) of a couple-based meditation (CBM) intervention that was delivered via videoconference. Based on previous behavioral interventions in BT, we hypothesized that at least 60% of couples would consent to participate, 75% of those randomized to the CBM group would attend at least 3 of the 4 sessions, and 60% of couples would be retained at the follow-up assessments.12 Additionally, we hypothesized that, compared with a usual care (UC) control group, the CBM intervention would yield at least medium effect sizes (ES) regarding improvements in patients’ cancer-related symptoms and patient and partner depressive symptoms and well-being outcomes.

METHODS

Participants

Patients were eligible if they (1) were diagnosed with a malignant glioma or any solid malignancy that had metastasized to the brain and currently receiving treatment; (2) had a Karnofsky Performance Status (KPS) of 80 or above; and (3) had a spouse/romantic partner willing to participate. Both patients and caregivers had to (1) be at least 18 years old and have the ability to (2) read and speak English; (3) be able to provide informed consent; and (4) have access to the internet. We excluded patients who (1) regularly (self-defined) participated in psychotherapy or a formalcancer support group and (2) had cognitive deficits that would impede the completion of self-report instruments as deemed by the clinical team.

Procedures

During clinic visits, the staff members approached potentially eligible patients and their partners, confirmed their eligibility, and obtained written informed consent prior to data collection. Patients completed the National Comprehensive Cancer Network (NCCN) Distress Thermometer at the time of consent. 24 Then, both patients and partners completed electronic (REDCap) survey measures (baseline/T1) prior to randomization. Electronic follow-up assessments were administered 6 weeks (T2) and 12 weeks later (T3). For each completed assessment, patients and partners received a $20 gift card (totaling $120 per couple). The MD Anderson Institutional Review Board approved all procedures prior to participant enrollment. All trial procedures (NCT03244995) were completed between September 2017 and December 2018.

Randomization

Couples were randomized based on patients’ prognostic factors of age, sex, KPS performance status, diagnosis (primary vs metastatic BT) and the NCCN distress score using a computerized system.

Intervention Group

Together the patient and partner dyad attended one session per week for four weeks (60 min. each). This dose was informed by previous dyadic emotional disclosure RCT.23 All sessions were administered via FaceTime by a master-level licensed psychological counselor intern. Based on their preference, participants used their own or a loaner device (i.e., iPad mini 4).

The CBM program is informed by the positive psychology literature and integrates both intrapersonal (i.e., meditations) and interpersonal (i.e., emotional sharing) components. First, during session 1, couples were experientially introduced to mindfulness meditation techniques by guiding their awareness to their current experience (i.e., self-regulation of attention) with a motivation of acceptance as described by Bishop et al.25 Then, participants were asked to bring this state of non-judgmental and fully present awareness to sharing their experiences with each other. During session 2, couples participated in two meditations that focused their attention on their interconnectedness and their feelings of compassion for the self and the partner.26 After each visualization exercise, couples were asked to take turns to mindfully share their reflections and experiences with each other continuing to cultivate a state of compassion for each other (no additional communications skills were taught). In session 3, couples were asked to reflect on things, events, and people for which they are grateful via a guided gratitude meditation followed by mindful and compassionate sharing.27 Session 4 was influenced by the value-based living process of Acceptance Commitment Therapy assisting couples in answering the question “What do you want your life to be about?” Couples completed a values worksheet and then a guided imagery reflection exercise to help identify their core values. The counselor then assisted couples to identify strategies that ensure that their lives reflect their self-identified values. Sessions were structured so that one-third of the time was devoted to check-ins and homework review/assignment, one-third to the meditations and one-third to the disclosure/reflections. Couples received a homework assignment after each session consisting of practicing the meditations, sharing their experiences, and completing written assignments (i.e., worksheets).

Control Group

The UC group received the usual care as provided by their health care team.

Measures

Demographic and Medical Factors.

Demographic items (e.g., age, race/ethnicity) were included in the baseline questionnaires. Patients’ medical data were extracted from their electronic medical records.

Feasibility Data.

We documented participants’ consent rates, study attrition, class attendance, and homework completion. Participants in the CBM group completed an evaluation of the intervention to assess their satisfaction.

Symptom Outcome Measures (higher scores mean worse symptoms)

Patient Cancer-Specific Symptoms were assessed with the MD Anderson Symptom Inventory-Brain Tumor module (MDASI-BT) which measures six factors including affective, cognitive, focal neurologic deficit, treatment-related, generalized symptom, and a gastrointestinal-related factor, which are presented here along with the inference (means scores, 0–10).28

Patient and Partner Depressive Symptoms were with the Center for Epidemiologic Studies Depression Scale (CES-D),29 a 20-item self-report measure focusing on the affective component of depression (summary score, 0–60).

Patient and Partner Well-being Outcome Measures (higher scores mean better well-being)

Mindfulness with the Mindful Attention Awareness Scale (MAAS),a 15-item scale assessing open or receptive awareness of and attention to what is taking place in the present (means score, 1–6).30

Compassion with the Self-Compassion Scale, a 12-item questionnaire that provides questions about self-judgments, self-kindness, common humanity, isolation, mindfulness and over-identification (means score, 1–5).31

Intimacy with 6 items from the Personal Assessment of Intimacy in Relationships (PAIR) Inventory32 which has been validated in cancer samples (means score, 1–5). 33,34

Data Analysis Plan

We calculated descriptive statistics of consent, session attendance, assessment completion, and program satisfaction. We used an intent-to-treat analysis when performing multilevel modeling (MLM) using PROC MIXED. We used separate analyses for patients and partners and controlled for baseline level of the given outcome. For patients, we also included the factors of age, sex, treatment history and tumor type (primary vs metastatic) as plausible a priori covariates when examining group least square means (LSM). In the partner models, we considered to control for partner’s age and sex as they were associated with the outcomes at P<.05. Because the current study is a pilot trial and not adequately powered, we supplemented the inferential statistics with effect sizes (Cohen’s d) associated with each between-group comparison interpreting effects as small ( d = .2), medium (d = .5) and large (d =.8).35 Group differences for the MDASI-BT subscales that were greater than 1-point were interpreted as clinically significant.28 Regarding sample size, we recruited as many dyads as feasible in a 12-month period with a minimum of 30 dyads based on Whitehead et al’s recommendation for a two-arm pilot trial to detect a medium effect size with 80% power and a two-sided 5% significance level.36

RESULTS

Participant Characteristics

Baseline demographic and medical data are listed in Table 1 by group and role. Briefly, about half of the patient sample was male (54%), mostly non-Hispanic White (77%), middle aged (mean=57.49 years, range=31–75) with at least some college credits (66%). More than half had a primary BT (63%). Partners were slightly more female (57%) than male, about half had completed at least some college credits (51%), were middle aged (mean=53.16 years, range=28–73), and almost half were full-time employed. The sample included one same-sex couple (female). Depressive symptoms were relatively low with 34% of patients and 27% of partners scoring at or above the CES-D caseness benchmark. There were no significant group differences regarding baseline participant characteristics except for time of diagnosis (P<.05).

Table 1.

Patient and Partners Baseline Characteristics by Group

Patient (n=35) Partners (n=35)
Characteristic CBM (n=18) Control (n=17) CBM (n=18) Control (n=17)
Gender, n (%)
 Male 10 (56) 9 (53) 8 (44) 7 (41)
 Female 8 (44) 8 (47) 10 (66) 10 (59)
Age, y, mean ± SD, (range) 57.67±12.18 (31–75) 55.82±11.00 (30–69) 56.67±13.21 (30–73) 52.12±10.95 (28–65)
Ethnicity, n (%)
 Non-Hispanic White 14 (78) 13 (81) 13 (72) 12 (75)
 Latino/Hispanic 3 (17) 2 (13) 3 (18) 2 (13)
Highest level of education, n (%)
 Some College or more 13 (72) 10 (59) 16 (89) 12 (71)
Household income, n (%)
 $75,000 or more 16 (89) 12 (71) 16 (89) 13 (76)
Employment status, n (%)
 Full-time 5 (28) 2 (13) 7 (39) 10 (63)
 Retired 5 (28) 5 (31) 4 (22) 4 (25)
 Part-time/Other 3 (16) 3 (18) 4 (22) 1 (6)
 Disability 5 (28) 6 (38) 3 (17) 1 (6)
Disease/Tumor Characteristics
Glioma 11 (61) 11 (65)
  WHO grade, n (%)
   IV 9 (82) 10 (91)
Metastatic 7 (39) 6 (35)
KPS, n (%)
 80 5 (28) 5 (29)
 90 8 (44) 8 (47)
 100 5 (28) 4 (24)
Time since diagnoses, weeks, mean ± SD, (range)* 18.64±26.87 (1.3–103.4) 41.30±63.10 (2.4–269.6)
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*

, denotes significant group difference at P<.05. Including time since diagnosis as an additional covariate in the analyses did not alter any of the findings reported here.

Feasibility Results

Recruitment and Sample Retention.

We screened 90 patients, and 60 were deemed eligible for study participation. Ineligibility was mainly due to a lack of a partner or consenting partner (n = 19) or a KPS of less than 80 (n=8). Of the eligible dyads, 37 (62%) consented. Two dyads withdrew consent prior to completing any study procedure. Of the 35 randomized dyads, 22 dyads completed the T2 and T3 assessments (63%). Attrition was mainly due to patients’ death (n=8), the impact of Hurricane Harvey (n=2), admission to hospice (n=2) and loss of contact (n=1). See Figure 1 for Consort Chart. There were no significant differences between completers and non-completers regarding group assignment and demographic/medical variables at P=0.1.

Figure 1.

Figure 1.

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Consort Chart

Adherence and Acceptability.

Couples randomized to the CBM group attended a mean of 3.33 sessions (SD=1.09; with 67% attending all 4 sessions and 78% attending at least 3 sessions). All participants in the CBM group rated each component of the intervention as either “beneficial” or “very beneficial”; the overall program as “useful” or “very useful”; and “frequently” discussed with their partner the intervention content outside of the sessions. All CBM participants would recommend the program to other couples with cancer and preferred dyadic as opposed to individual or group attendance. None of the patients and only one partner indicated that they had some difficulties with the online delivery format. Home practice was acceptable with, depending on the particular session, 50–70% of patients and partners completing the assignments between sessions. No role differences in home practice was found.

Preliminary Efficacy Results

Patient Cancer-Specific Symptoms.

Based on MLM analyses including the above mentioned covariates, we found clinically and statistically significant differences for the cognitive (LSM, CBM: 1.11 vs. UC: 2.95; F=4.84, P<.05; d=1.05) and general disease (LSM, CBM: 1.71 vs. UC: 3.25; F=4.65, P<.05; d=.93) symptom subscales. Group differences for the symptom interference was clinically significant (means, CBM: 3.43 vs. UC: 4.71; F=1.78, P=.20; d=.49). LSM for each MDASI-BT subscale are presented in Figure 2, respectively.

Figure 2.

Figure 2.

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Least Square Means and Cohen’s d Effect Sizes from the Multi-Level Modeling Analyses for Patients’ MD Anderson Symptom Inventory-Brain Tumor Module

Abbreviations: GI, Gastrointestinal. Cohen’s d35 for group differences at using least square means (adjusted for baseline levels, tumor type, age, sex, time point, and treatment history) and pooled standard deviations. Significant group differences denoted *P<.05. Clinically significant group differences denoted +.

Depressive Symptoms.

Group differences for patients were marginally significant representing a medium-to-large effect size (LSM, CBM: 13.80 vs. UC: 20.68; F=3.91, P=.06; d=.70). For partners, there was no significant between-group difference across the follow-up period (LSM, CBM: 11.38 vs. UC: 11.46).

Well-being Measures

Mindfulness.

No significant group differences for patients (LSM, CBM: 4.79 vs. UC: 4.55) or partners (LSM, CBM: 4.34 vs. UC: 4.40) were found.

Compassion.

Marginally significant differences with a large effect size were revealed for patients (LSM, CBM: 3.78 vs. UC: 3.28; F=5.98, P=.03, d=.96) so that patients in the CBM group reported more compassion than those in the UC group. For partners, no group differences were found (LSM, CBM: 3.72 vs. UC: 3.77).

Intimacy.

Similarly, significant group differences in favor of the CBM group with a medium-to-large effect size were revealed for patients (LSM, CBM: 4.45 vs. UC: 3.93; F=7.63, P<.05; d=.68) but no effect for partners was found (LSM, CBM: 3.84 vs. UC: 3.74).

DISCUSSION

This pilot RCT demonstrated the feasibility and preliminary efficacy of a CBM intervention for BT patients and their partners. The results revealed that the trial was feasible as it met our a priori feasibility criteria regarding consent, retention, and adherence rates. Of note, 78% of dyads in the CBM group attended at least 3 of the 4 sessions. High intervention acceptability was further demonstrated in that all participants in the CBM group rated each component of the intervention as beneficial and the overall program as useful; preferred dyadic over individual or group attendance; and would recommend the program to other couples with cancer. The videoconference delivery was also acceptable as only one participant indicated having experienced some difficulties with Facetime.

We also revealed promising findings for patients’ cancer-related symptoms severity in the areas of cognitive and general disease symptoms as well as symptom interference. Patients in the CBM group also reported marginally significant improvements in depressive symptoms (medium effect size) relative to those in the UC group. Although we found no effect for mindfulness, we were encouraged by the significant improvements in relationship well-being and compassion ratings for patients in the CBM relative to those in the UC group. For partners, the findings were disappointing as no effects were revealed in any of the measures despite their reports of having benefited from the program. This finding supports a small mindfulness-based stress reduction RCT demonstrating improvements for lung cancer patients but not partners.37

Although this pilot work only revealed significant effects for patients, a future, larger trial still appears to be warranted. Yet, crucial issues must be addressed in future research. For example, it is unclear if a dyadic design is necessary for patients to experience treatment benefits. A trial designed to directly compare a dyadic vs individual delivery approach of the intervention is necessary to address this concern. However, as supported by the behavioral literature, we are confident that a dyadic design increases feasibility particularly retention.38,39 In contrast, the 2-month retention rate of a large psychosocial intervention trial enrolling patients with advanced cancer was 40%.40 Here, we were able to retain 62% at the 3-months follow-up. Regarding partners, a caregiver-focused, rather than a dyadic, intervention delivery may be more effective.8 We are currently testing a dyadic versus caregiver-focused design.41

Our study is limited by the sample’s fairly homogenous characteristics particularly regarding race/ethnicity and socio-economic status. The study lacked an active comparison arm controlling for attention and support; thus, any group differences may be due to these non-specific effects rather than the intervention itself. This pilot RCT was not powered to examine group differences, and the initial evidence for efficacy presented here must be interpreted with caution.

Conclusions

The current pilot RCT has provided strong evidence of the feasibility of the CBM intervention using videoconferencing delivery. Patients and partners rated the intervention as beneficial and useful. We demonstrated preliminary efficacy regarding patients’ cognitive and general disease symptoms, symptom interference, depressive symptoms as well as relationship well-being and compassion. Thus, a larger, well-controlled efficacy trial of CBM is warranted.

Acknowledgements

This research was supported by the Hackett Family Foundation of The University of Texas MD Anderson Cancer Center and NIH/NCCIH K01 AT007559, Principal Investigator: Kathrin Milbury.

Footnotes

Disclosures

None of the authors have a potential or actual conflict of interest.

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