kankergerelateerde vermoeidheid chronic cancer-related fatigue fatigue
Conditions
Interventions
The couple eMBCT has nine sessions, takes 15-20 weeks, can be followed from
home and will be supervised remotely by a trained psychotherapist. Consistent
with the original eMBCT, the couple eMBCT ai
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the intervention acceptability, which is operationalized as couples* intervention adherence (according to self-report and therapist record), and couples* intervention experiences as assessed at T1. Evidence supporting the intervention acceptability is achieved when >= 60% of couples complete the intervention and >= 70% of patients and >= 70% of partners report to be satisfied with the dyadic approach and the overall intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| To examine the feasibility of trial procedures (i.e. rates related to the recruitment procedure and adherence to the study protocol) and to determine the potential working mechanisms of the couple intervention (i.e. co-occurrence of changes in targeted weekly-assessed mindfulness- and cognitive-behavioral variables and fatigue). | — |
Countries
Netherlands
Outcome results
None listed