AzTrials
AzTrials

NeoplasmsCOMPANIONNCT05636696

COMPANION: A Couple Intervention Targeting Cancer-related Fatigue

A study testing Samen Minder Moe (Dutch intervention name) in people with Neoplasms and Fatigue, run by Mariët Hagedoorn at 2 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Neoplasms, Fatigue
What is being tested?
Samen Minder Moe (Dutch intervention name)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesNetherlands
Study dates
21 Sep 2022to 21 Mar 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Netherlands2 sites

  • Helen Dowling Institute

    Bilthoven, 3723 MB

  • University Medical Center Groningen

    Groningen, 9700 RB

Other trials in Netherlands

About this study

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

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.

Read the 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
Being tested
Samen Minder Moe (Dutch intervention name)
Keywords
Chronic cancer-related fatigue, Cancer, Behavioral intervention, Mindfulness intervention, Dyadic intervention, Pilot, Partners, Spouses
Medical subject headings
Neoplasms, Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Samen Minder Moe (Dutch intervention name)Behavioural

    Also called COMPANION, couple eMBCT

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

Study groups in NCT05636696
Study groupRoleWhat they receive
couple eMBCTExperimentalThe 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.
Receives: Behavioral: Samen Minder Moe (Dutch intervention name)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Throughout intervention completion, about 15-20 weeks per couple

  2. 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.

    Measured: Throughout intervention completion, about 15-20 weeks per couple

  3. 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.

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

Secondary outcomes (4)

  1. Feasibility of trial procedures operationalized as recruitment rate

    Benchmark:

    Recruitment rate: ≥ 3 couples included per month, averaged across both recruitment strategies.

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

  2. 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.

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

  3. Feasibility of trial procedures operationalized as diary adherence rate

    Diary adherence rate: ≥ 65% of diaries completed (11-14 diaries) by both patients and partners.

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

  4. 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).

    Measured: During diary period, 17-22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start21 Sep 2022
  3. Primary completion21 Jan 2024 (estimated)
  4. Study completion21 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05636696
Sponsor's protocol ID
202100817
Other IDs
KWF-12794, NL80201.042.22
Acronym
COMPANION
Status last verified
Jul 2023
First submitted
31 Oct 2022
Last updated
25 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Collected quantitative IPD (questionnaires, diaries) can potentially be shared.

Publications

  • 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.

    PubMed 37930767

Questions about this trial

What is this clinical trial studying?

A study testing Samen Minder Moe (Dutch intervention name) in people with Neoplasms and Fatigue, run by Mariët Hagedoorn at 2 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of the couple eMBCT operationalized as intervention adherence (time frame: Throughout intervention completion, about 15-20 weeks per couple). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05636696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in