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Psychological distress in partners of cancer patients


- candidate number15003
- NTR NumberNTR4035
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2013
- Secondary IDs5248  KWF Kankerbestrijding/ Stichting Alpe d
- Public TitlePsychological distress in partners of cancer patients
- Scientific TitlePsychological distress in partners of cancer patients
- ACRONYM
- hypothesisThe main goal of the study is to determine the (cost-) efficacy of this online psychological intervention for partners of cancer patients on psychological distress and (positive) mental health. To obtain insight in possible determinants of the effects of the intervention on psychological distress in partner of cancer patients, potential predictors include socio-demographics, disease-related, psychological, social factors and caregiving burden measured at baseline.
- Healt Condition(s) or Problem(s) studiedPsychological distress, Mental health problems
- Inclusion criteria- Age >= 18 years;
- Being partner of an cancer patient or cancer survivor;
- Having internet access, and having an e-mail address;
- Being able to speak, write and read Dutch language;
- Having mild to moderate depressive symptoms (>10 and <39 on the Center of Epidemiological Studies¡ªdepression scale (CES-D); Radloff, 1977) and anxiety symptoms (>3 and <15 on the Hospital Anxiety and Depression Scale- anxiety subscale (HADS-A); Zigmond & Snaith, 1983).
- Exclusion criteria- Severe scores on either HADS-A (>=15) or CES-D (>=39);
- Receiving current psychological or psychopharmacological treatment within the last three months;
- Not being able to spend 1-1.5 hours on the intervention every week;
- Partner died because of cancer.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2013
- planned closingdate30-nov-2013
- Target number of participants234
- InterventionsThe online psychological intervention 'Hold on, for each other' is based on behavioural therapy (Acceptance and Commitment therapy (ACT)), mindfulness and self-compassion. There are 6 modules (plus one additional module depending on the stage of disease) which can be worked through in 6-14 weeks. Participants can follow the module at home at a time that suits their convenience. Participants receive short informative texts, exercises on acceptance, mindfulness and self-compassion, practical information, tips and further relevant references, poems or inspiring messages. Besides that, participants are offered the possibility to share their answers on some of the exercises with some other participants (anonymously) and they can also contact participants if they want to. Two versions of the intervention will be tested. In the experimental condition 1 participants will receive short feedback by a counsellor once a week. In the experimental condition 2, participants will receive automated feedback by a virtual counsellor after finishing the exercises of the module.
- Primary outcomePsychological distress (depression, anxiety and) and positive mental health.
- Secondary outcome- general health
- health related quality of life
- caregiver strain
- self esteem
- psychological flexibility
- self-compassion
- support styles and support behavior
- mastery
- resilience
- posttraumatic growth
- Timepoints- intake
- baseline measurement & randomisation
- post-intervention (3 months after the baseline measurement)
- follow-up (6 and 12 months after the baseline measurement).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Constance H.C. Drossaert
- CONTACT for SCIENTIFIC QUERIES Nadine Köhle
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Alpe d’HuZes Foundation, KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryRationale: There is consistent evidence that partners of cancer patients are at risk of experiencing anxiety, depression, fatigue and sleep problems. Recent studies have shown that clinical levels of psychological distress are highly prevalent in partners of cancer patients and can even be higher than in people with cancer themselves. On the basis of the need for evidence-based, supportive interventions for partners of cancer patients and the limited availability of such interventions in current practice in the Netherlands, the University of Twente developed the online intervention ‘Hold on, for each other’.

Objective: The main goal of the study is to determine the (cost-) efficacy of this online psychological intervention for partners of cancer patients on psychological distress and (positive) mental health. To obtain insight in possible determinants of the effects of the intervention on psychological distress in partner of cancer patients, potential predictors include socio-demographics, disease-related, psychological, social factors and caregiving burden measured at baseline.

Study design: A prospective randomized controlled trial will be carried out with three parallel groups:
- Experimental condition 1: Web-based intervention ‘Hold on, for each other’ with personal feedback.
- Experimental condition 2: Web-based intervention ‘Hold on, for each other’ with automatic feedback from a virtual counsellor.
- Waiting list control condition: Participants will be on a waiting list for 3 months from entry/intake.

Study population: The population consists of adult partners of cancer patients or cancer survivors with mild to moderate depressive and anxiety symptoms. They will be recruited by putting advertisements in national newspapers and on websites of relevant patients associations and drop-in centres (inloophuizen) for patients and their partners, and by offering all cancer patients and their partners who visit one of the participating hospitals (MST, VUmc) or integral cancer centres for treatment or aftercare a leaflet with information about the study.

Intervention (if applicable): “Hold on, for each other” is based on Acceptance and Commitment therapy (ACT), mindfulness and self-compassion. There are 6-7 modules which can be worked through in 6-14 weeks. Participants can follow the intervention at home at a time that suits their convenience. Participants receive short informative texts, exercises on acceptance, mindfulness and self-compassion, practical information, tips and further relevant references, poems or inspiring messages. Besides that, participants are offered the possibility to share their answers on some of the exercises with some other participants (anonymously) and they can also contact participants if they want to.

Main study parameters/endpoints: Main study parameters are (1) psychological distress measured with the Hospital Anxiety and Depression Scale- anxiety subscale (HADS-A) and the Center for Epidemiologic Studies Depression Scale (CES-D) and (2) (positive) mental health measured with the Mental Health Continuum Short Form (MHC-SF). The main study parameters will be measured at four measurement points from baseline until follow-up at 12 months in the intervention and control conditions.
- Main changes (audit trail)
- RECORD17-jun-2013 - 29-jun-2013


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