NCT05636696

COMPANION: A Couple Intervention Targeting Cancer-related Fatigue

COMPANION Study: A Pilot Trial Testing Couple Mindfulness-based Cognitive Behavioral Therapy Via Internet Targeting Cancer-related Fatigue [Workpackage 2]

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Mariët Hagedoorn · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Neoplasms
• Fatigue

Interventions

Type	Name	Description
BEHAVIORAL	Samen Minder Moe (Dutch intervention name)	'Samen Minder Moe' is a mindfulness-based cognitive behavioral therapy for cancer-related fatigue directed at couples.

Timeline

• Start date: 2022-09-21
• Primary completion: 2024-01-21
• Completion: 2024-03-21
• First posted: 2022-12-05
• Last updated: 2023-07-25

Locations

2 sites across 1 country: Netherlands