COMPANION: A Couple Intervention Targeting Cancer-related Fatigue

NCT05636696 | Unknown

• 3 other identifiers: 202100817KWF-12794NL80201.042.22
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neoplasms; Fatigue

Keywords

Chronic cancer-related fatigue; Cancer; Behavioral intervention; Mindfulness intervention; Dyadic intervention; Pilot; Partners; Spouses

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From the pre-intervention baseline assessment (Timepoint 0) to the post-intervention assessment, 2 weeks after intervention completion (Timepoint 1)

Secondary Outcomes (4)

• Feasibility of trial procedures operationalized as recruitment rate

  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

  Throughout study conduction, i.e. during the (planned) total of 18 months of data collection

• Feasibility of trial procedures operationalized as diary adherence rate

  Throughout study conduction, i.e. during the (planned) total of 18 months of data collection

• Potential working mechanisms of couple eMBCT

  During diary period, 17-22 weeks

Study Arms (1)

couple eMBCT

EXPERIMENTAL

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.

Behavioral: Samen Minder Moe (Dutch intervention name)

Interventions

Samen Minder Moe (Dutch intervention name) BEHAVIORAL

'Samen Minder Moe' is a mindfulness-based cognitive behavioral therapy for cancer-related fatigue directed at couples.

Also known as: COMPANION, couple eMBCT

couple eMBCT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only couples are eligible for participation. In order to be eligible, the couple must meet each of the following criteria:
• The patient has received a cancer diagnosis (all malignancies will be included);
• The patient completed cancer treatment with either curative or palliative intent ≥ 3 months earlier. Patients who currently receive hormone therapy are eligible;
• The patient experiences severe levels of fatigue (score of ≥ 35 on the Checklist Individual Strength, subscale fatigue severity (CIS-fatigue));
• The patient has been suffering from severe fatigue for ≥ 3 months (as self-reported by the patient);
• The patient was ≥ 18 years old at disease onset;
• The partner is ≥ 18 years old;
• Both couple members live together;
• Both couple members have good command of the Dutch language (checked implicitly during registration);
• Both couple members have adequate computer literacy and have access to an internet-connected computer, laptop or tablet (based on self-report);
• Both couple members agree to participate in the research.

You may not qualify if:

• The couple will be excluded in case:
• 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;
• The patient suffers from a condition that can explain his/her fatigue and is potentially treatable (e.g. anemia);
• 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 substance abuse, except for smoking.

Sponsors & Collaborators

• Mariët Hagedoorn: lead
• Helen Dowling Institute: collaborator

Study Sites (2)

Helen Dowling Institute

Bilthoven, 3723 MB, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

• Muller 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 DERIVED

Related Links

• Study website (in Dutch)

MeSH Terms

Conditions

Neoplasms; Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mariët Hagedoorn, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a 1-arm pilot trial. All eligible and consenting couples will be allocated to the couple eMBCT named 'COMPANION' (Dutch name: 'Samen Minder Moe'). No randomization takes place. The couple eMBCT was developed based on the evidence-based eMBCT directed (only) at patients. The couple eMBCT entails nine sessions, takes 15-20 weeks, can be followed from home and will be supervised remotely by a trained psychotherapist. 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 extra information for partners each session, the possibility for partners to perform exercises and one extra session 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.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: December 5, 2022
• Study Start: September 21, 2022
• Primary Completion: January 21, 2024
• Study Completion: March 21, 2024
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study completion and publication of outcome data.
• Access Criteria: The anonymized data that support the findings of this study will become available from the principle investigators upon reasonable request, including a data analysis plan and research questions. Permission for data sharing will be asked from the medical ethical commission.

Locations

NL (2)