JMIR Publications

ABSTRACT

Background:

Chronic cancer-related fatigue is a common symptom among patients treated with curative and palliative intent. Current interventions typically target the patient alone despite growing evidence suggesting that a dyadic approach can increase and broaden an intervention’s efficacy. Therefore, based on the existing mindfulness-based cognitive behavioral therapy for patients, the couple intervention COMPANION was developed.

Objective:

Primary objectives 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.

Methods:

This is a 1-arm pilot trial. Assessments include three questionnaires (i.e., before starting the intervention (T0), after completing the intervention (T1), and 1 month after T1 (T2)) and the completion of weekly diaries. A subsample of patients (n ≈ 5) and partners (n ≈ 5) as well as the therapists providing the couple intervention will participate in final focus groups. Cancer survivors and their partners are included. The main inclusion criteria are that the patient of the couple has a cancer diagnosis, has completed treatment since ≥ 3 months, and experiences severe fatigue since ≥ 3 months. The target sample size is 34 couples. Recruitment takes place via a hospital, the Helen Dowling Institute, a specialized mental healthcare center for cancer patients and/or their close others, and self-referral. All participating cancer survivors and their partners will be allocated to the couple intervention. COMPANION consists of nine sessions, takes 15-20 weeks, is provided online and is supervised remotely by a trained therapist.

Results:

As of April 2023, 9 couples have been included.

Conclusions:

Findings will indicate whether proceeding to a randomized controlled trial is warranted. Benchmark values were defined to this end. Acceptability would be achieved if ≥ 60% of couples complete the intervention and/or ≥ 70% of patients and ≥ 70% of partners report to be satisfied with the intervention overall and/or the dyadic approach. Potential efficacy would be achieved if there is a significant improvement in mean fatigue severity between T0 and T1 and/or if ≥ 45% of patients show a clinically-relevant improvement in fatigue severity between T0 and T1. The trial procedures would be deemed feasible if an average of ≥ 3 couples are included per month and/or adherence to the questionnaire is ≥ 65% and ≥ 60% of patients and partners for T1 and T2, respectively. The benchmark for the weekly diary adherence is ≥ 65% for patients and partners. A variable is considered a potential working mechanism of the intervention if its improvement over the course of the diary period covaries with the expected decrease in weekly-measured fatigue. Quantitative outcomes will be interpreted along with results from the focus groups. Clinical Trial: ClinicalTrials.gov (NCT05636696)