- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05636696
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue (COMPANION)
COMPANION Study: A Pilot Trial Testing Couple Mindfulness-based Cognitive Behavioral Therapy Via Internet Targeting Cancer-related Fatigue [Workpackage 2]
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mariët Hagedoorn, PhD
- Phone Number: +31 50 361 6662
- Email: mariet.hagedoorn@umcg.nl
Study Contact Backup
- Name: Fabiola Müller, PhD
- Email: f.muller@umcg.nl
Study Locations
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Bilthoven, Netherlands, 3723 MB
- Helen Dowling Institute
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Groningen, Netherlands, 9700 RB
- University Medical Center Groningen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: couple eMBCT
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.
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'Samen Minder Moe' is a mindfulness-based cognitive behavioral therapy for cancer-related fatigue directed at couples.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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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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.
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)
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Acceptability of the couple eMBCT operationalized as intervention adherence
Time Frame: Throughout intervention completion, about 15-20 weeks per couple
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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
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Acceptability of the couple eMBCT operationalized as satisfaction with the intervention
Time Frame: Throughout intervention completion, about 15-20 weeks per couple
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of trial procedures operationalized as recruitment rate
Time Frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Benchmark: Recruitment rate: ≥ 3 couples included per month, averaged across both recruitment strategies. |
Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Feasibility of trial procedures operationalized as T1 and T2 assessment adherence rate
Time Frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Benchmark: T1 and T2 adherence rate: ≥ 65% of patients and partners complete the T1 and ≥ 60% of patients and partners complete the T2 questionnaire. |
Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Feasibility of trial procedures operationalized as diary adherence rate
Time Frame: Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Diary adherence rate: ≥ 65% of diaries completed (11-14 diaries) by both patients and partners.
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Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
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Potential working mechanisms of couple eMBCT
Time Frame: During diary period, 17-22 weeks
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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). |
During diary period, 17-22 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mariët Hagedoorn, PhD, University Medical Center Groningen
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202100817
- KWF-12794 (Other Grant/Funding Number: Dutch Cancer Society)
- NL80201.042.22 (Other Identifier: CCMO register (ABR))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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