Clinical trial · Interventional
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]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fatigue | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Samen Minder Moe (Dutch intervention name) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- couple eMBCT
- description
- The couple eMBCT has nine sessions, takes 15-20 weeks, can be followed from home and will be supervised remotely by a trained therapist. Consistent with the original (patient-only) eMBCT, the couple eMBCT aims to change the patient's behavioral and cognitive reactions to fatigue and other cancer-related stressors. Couple eMBCT includes information for partners each session, the possibility for partners to perform exercises and one session specifically dedicated to the couple's mutual relationship and mindful communication about CCRF. Couples can determine themselves to which degree the partner is involved in the therapy.
- interventionNames
- Behavioral: Samen Minder Moe (Dutch intervention name)
Primary outcomes (3)
- measure
- Acceptability of the couple eMBCT operationalized as intervention adherence
- timeFrame
- Throughout intervention completion, about 15-20 weeks per couple
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Only couples are eligible for participation. In order to be eligible, the couple must meet each of the following criteria: 1. The patient has received a cancer diagnosis (all malignancies will be included); 2. The patient completed cancer treatment with either curative or palliative intent ≥ 3 months earlier. Patients who currently receive hormone therapy are eligible; 3. The patient experiences severe levels of fatigue (score of ≥ 35 on the Checklist Individual Strength, subscale fatigue severity (CIS-fatigue)); 4. The patient has been suffering from severe fatigue for ≥ 3 months (as self-reported by the patient); 5. The patient was ≥ 18 years old at disease onset; 6. The partner is ≥ 18 years old; 7. Both couple members live together; 8. Both couple members have good command of the Dutch language (checked implicitly during registration); 9. Both couple members have adequate computer literacy and have access to an internet-connected computer, laptop or tablet (based on self-report); 10. Both couple members agree to participate in the research. Exclusion Criteria: The couple will be excluded in case: 1. The patient is currently following an evidence-based therapy for CCRF (i.e. Cognitive-Behavioral Therapy, mindfulness-based therapy, exercising/physiotherapy) as self-reported at the (telephone) screening; 2. The patient suffers from a condition that can explain his/her fatigue and is potentially treatable (e.g. anemia); 3. The therapist decides, based on information collected during the intake session, that the intervention is not suitable for the couple. Criteria that will be considered include, but are not limited to: * presence of severe psychiatric morbidity such as suicidal ideation and/or psychosis (as assessed by the therapist at the intake session). Mild depression is not an exclusion criterion. A score of ≥ 20 on the Hospital Anxiety and Depression Scale (HADS) at T0 is considered indicative of depression. Therefore, if the patient or the partner scores ≥ 20, the therapist will determine at the intake whether the participant has suicidal ideation or suffers from other severe psychiatric morbidity. A participant (and thus the couple) will be excluded if, according to the therapist, that is the case; * presence of substance abuse, except for smoking.
References
Publications (1)
- DERIVEDMuller F, van Dongen S, van Woezik R, Tibosch M, Tuinman MA, Schellekens MPJ, Laurenceau JP, van der Lee M, Hagedoorn M. A Web-Based Mindfulness-Based Cognitive Therapy for Couples Dealing With Chronic Cancer-Related Fatigue: Protocol for a Single-Arm Pilot Trial. JMIR Res Protoc. 2023 Nov 6;12:e48329. doi: 10.2196/48329. PMID 37930767