COMPANION study: A pilot trial testing couple mindfulness-based cognitive behavioral therapy via internet targeting cancer-related fatigue [workpackage 2]
- Conditions
- kankergerelateerde vermoeidheidchronic cancer-related fatiguefatigue
- Registration Number
- NL-OMON51707
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 68
Only couples are eligible for participation. In order to be eligible, the
couple must meet each of the following criteria:
1. the patient has a cancer diagnosis (all malignancies will be included) as
confirmed with the medical (GP) record;
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
CIS-Subjective Fatigue [CIS-SF] subscale);
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.
The couple will be excluded in case:
1. the patient is currently following an evidence-based therapy for CCRF (i.e.
CBT, 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), as checked with the medical record;
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 HADS at T0 is considered
indicative of depression (Le Fevre, Devereux, Smith, Lawrie, & Cornbleet,
1999). 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.
If a couple gets excluded due to somatic or psychiatric problems of one or both
partners, a referral to GP will take place.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints are the intervention acceptability, which is<br /><br>operationalized as couples* intervention adherence (according to self-report<br /><br>and therapist record), and couples* intervention experiences as assessed at T1.<br /><br>Evidence supporting the intervention acceptability is achieved when >= 60% of<br /><br>couples complete the intervention and >= 70% of patients and >= 70% of partners<br /><br>report to be satisfied with the dyadic approach and the overall intervention.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To examine the feasibility of trial procedures (i.e. rates related to the<br /><br>recruitment procedure and adherence to the study protocol) and to determine the<br /><br>potential working mechanisms of the couple intervention (i.e. co-occurrence of<br /><br>changes in targeted weekly-assessed mindfulness- and cognitive-behavioral<br /><br>variables and fatigue).</p><br>