Chronic cancer-related fatigue (CCRF) is a disturbing condition that persists in up to 25% of cancer patients after completion of treatment. While mindfulness-based interventions are effective in relieving CCRF, these typically target the patient alone. Growing evidence suggests that including partners and targeting the dyadic context can increase and broaden the interventions' efficacy. The proposed study is a pilot trial testing the acceptability and potential efficacy of a mindfulness intervention directed at couples.
This is a 1-arm pilot trial. Recruitment will take place via a hospital, the Helen Dowling Institute and self-referral. The target is to include 34 couples (i.e. 68 participants). All participating cancer patients and their partners will be allocated to the couple mindfulness-based cognitive behavioral therapy, provided via internet (couple eMBCT), called 'COMPANION' (in Dutch: 'Samen Minder Moe') Assessments include three questionnaires (i.e. before starting the intervention (T0), after completing the intervention (T1), and 1 month after T1 (T2)). The assessments include also weekly diaries during a period of 17-22 weeks. A subsample of patients (n ≈ 5) and partners (n ≈ 5) as well as the therapists providing the couple eMBCT will participate in final focus groups. The primary objectives of COMPANION study 2 are to determine the acceptability of the couple intervention and the potential efficacy for patient fatigue. Secondary objectives are to examine the feasibility of trial procedures and the potential working mechanisms of the couple intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
'Samen Minder Moe' is a mindfulness-based cognitive behavioral therapy for cancer-related fatigue directed at couples.
Helen Dowling Institute
Bilthoven, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Acceptability of the couple eMBCT operationalized as intervention adherence
Operationalized as percentage of couples in which the patient completed the intervention and the partner did not drop out from it. Patients' intervention completion will be recorded in the therapist log and assessed by patient self-report. If either one satisfies the completion criterion, the couple will be considered as intervention completers. Benchmark: \>= 60% of couples completed the intervention.
Time frame: Throughout intervention completion, about 15-20 weeks per couple
Acceptability of the couple eMBCT operationalized as satisfaction with the intervention
Quantitatively operationalized as satisfaction with the dyadic approach and the intervention overall (score \>= 5 indicates satisfaction, (couples only, not therapists) as assessed at T1, 2 weeks after intervention completion. Benchmark: \>= 70% of patients and 70% of partners indicating on the T1 questionnaire to be satisfied.
Time frame: Throughout intervention completion, about 15-20 weeks per couple
Potential efficacy on patient fatigue as assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue) from pre-intervention (T0) to 2 weeks post-intervention (T1)
Fatigue is assessed with the Checklist Individual Strength, subscale fatigue severity (CIS-fatigue) on T0 (pre-intervention) and T1 (approx. 2 weeks after intervention completion). Eight items are rated on a 7-point scale, measuring fatigue in the preceding 2 weeks. The scale score ranges between 8 and 56, with a higher score indicating a higher level of fatigue. 1. Change in patient fatigue. The change in fatigue from T0 to T1 is tested with a matched pairs t-test and according to the intention-to-treat principle. Benchmark: a statistically significant (p \< .05) decrease in patient fatigue between T0 and T1. 2. Clinically relevant change in patient fatigue. Operationalized as a reduction on the CIS-fatigue from T0 to T1 of at least 6-points. Benchmark: ≥ 45% of patients score on T1 at least 6 points lower than on T0.
Time frame: From the pre-intervention baseline assessment (Timepoint 0) to the post-intervention assessment, 2 weeks after intervention completion (Timepoint 1)
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Feasibility of trial procedures operationalized as recruitment rate
Benchmark: Recruitment rate: ≥ 3 couples included per month, averaged across both recruitment strategies.
Time frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Feasibility of trial procedures operationalized as T1 and T2 assessment adherence rate
Benchmark: T1 and T2 adherence rate: ≥ 65% of patients and partners complete the T1 and ≥ 60% of patients and partners complete the T2 questionnaire.
Time frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Feasibility of trial procedures operationalized as diary adherence rate
Diary adherence rate: ≥ 65% of diaries completed (11-14 diaries) by both patients and partners.
Time frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Potential working mechanisms of couple eMBCT
Diary data will be analyzed to assess the intervention's potential working mechanisms, i.e. whether expected improvements in targeted variables co-occur with the expected reduction in patient fatigue. The putative mechanism variables are: affect, sleep, catastrophizing, partner communication, partner interactions, self-efficacy, mindfulness and closeness. Multilevel growth curve analysis will be applied to model the time slopes of the potential mechanisms and weekly fatigue over the entire diary period. A variable is interpreted as potential working mechanism in case the standardized covariance between the slope change factor for the outcome (fatigue) and that of the presumed mediator is significant (using a z-test where +/-1.96 is significant at the .05 level).
Time frame: During diary period, 17-22 weeks