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COMPANION: A Couple Intervention Targeting Cancer-related Fatigue (COMPANION)

Primary Purpose

Neoplasms, Fatigue

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Samen Minder Moe (Dutch intervention name)
Sponsored by
Mariët Hagedoorn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Neoplasms focused on measuring Chronic cancer-related fatigue, Cancer, Behavioral intervention, Mindfulness intervention, Dyadic intervention, Pilot, Partners, Spouses

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Helen Dowling Institute
  • University Medical Center Groningen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

couple eMBCT

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.
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. 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. 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.

Secondary Outcome Measures

Feasibility of trial procedures operationalized as recruitment rate
Benchmark: Recruitment rate: ≥ 3 couples included per month, averaged across both recruitment strategies.
Feasibility of trial procedures operationalized as T1 and T2 assessment adherence rate
Benchmark: T1 and T2 adherence rate: ≥ 65% of patients and partners complete the T1 and ≥ 60% of patients and partners complete the T2 questionnaire.
Feasibility of trial procedures operationalized as diary adherence rate
Diary adherence rate: ≥ 65% of diaries completed (11-14 diaries) by both patients and partners.
Potential working mechanisms of couple eMBCT
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).

Full Information

First Posted
October 31, 2022
Last Updated
July 24, 2023
Sponsor
Mariët Hagedoorn
Collaborators
Helen Dowling Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05636696
Brief Title
COMPANION: A Couple Intervention Targeting Cancer-related Fatigue
Acronym
COMPANION
Official Title
COMPANION Study: A Pilot Trial Testing Couple Mindfulness-based Cognitive Behavioral Therapy Via Internet Targeting Cancer-related Fatigue [Workpackage 2]
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
January 21, 2024 (Anticipated)
Study Completion Date
March 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mariët Hagedoorn
Collaborators
Helen Dowling Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Fatigue
Keywords
Chronic cancer-related fatigue, Cancer, Behavioral intervention, Mindfulness intervention, Dyadic intervention, Pilot, Partners, Spouses

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
couple eMBCT
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Samen Minder Moe (Dutch intervention name)
Other Intervention Name(s)
COMPANION, couple eMBCT
Intervention Description
'Samen Minder Moe' is a mindfulness-based cognitive behavioral therapy for cancer-related fatigue directed at couples.
Primary Outcome Measure Information:
Title
Acceptability of the couple eMBCT operationalized as intervention adherence
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.
Time Frame
Throughout intervention completion, about 15-20 weeks per couple
Title
Acceptability of the couple eMBCT operationalized as satisfaction with the intervention
Description
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.
Time Frame
Throughout intervention completion, about 15-20 weeks per couple
Title
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)
Description
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. 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. 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.
Time Frame
From the pre-intervention baseline assessment (Timepoint 0) to the post-intervention assessment, 2 weeks after intervention completion (Timepoint 1)
Secondary Outcome Measure Information:
Title
Feasibility of trial procedures operationalized as recruitment rate
Description
Benchmark: Recruitment rate: ≥ 3 couples included per month, averaged across both recruitment strategies.
Time Frame
Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Title
Feasibility of trial procedures operationalized as T1 and T2 assessment adherence rate
Description
Benchmark: T1 and T2 adherence rate: ≥ 65% of patients and partners complete the T1 and ≥ 60% of patients and partners complete the T2 questionnaire.
Time Frame
Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Title
Feasibility of trial procedures operationalized as diary adherence rate
Description
Diary adherence rate: ≥ 65% of diaries completed (11-14 diaries) by both patients and partners.
Time Frame
Throughout study conduction, i.e. during the (planned) total of 18 months of data collection
Title
Potential working mechanisms of couple eMBCT
Description
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).
Time Frame
During diary period, 17-22 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariët Hagedoorn, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helen Dowling Institute
City
Bilthoven
ZIP/Postal Code
3723 MB
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Collected quantitative IPD (questionnaires, diaries) can potentially be shared.
IPD Sharing Time Frame
After study completion and publication of outcome data.
IPD Sharing 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.
Links:
URL
http://www.hdi.nl/companion
Description
Study website (in Dutch)

Learn more about this trial

COMPANION: A Couple Intervention Targeting Cancer-related Fatigue

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