"Resilient Caregivers" - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Danish Cancer Society
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Change in symptoms of anxiety
Study Overview
Brief Summary
The objective of this study is to develop and test the effectiveness of a resilience-based intervention for distressed partner caregivers of cancer patients in reducing symptoms of anxiety, depression and distress, while improving quality of life and resilience (meta-reflective skill, values clarification and coping strategies).
Detailed Description
Informal caregivers of cancer patients often experience significant psychological distress, which may even exceed that of the patient's. Partners or spouses are typically the most important caregiver and emotional support person for the cancer patient, but there is a lack of psychological interventions that specifically target caregiving partners. "Resilient Caregivers" is a novel 7-session group-based program aimed specifically at improving the participant's ability to cope with the stresses of being a partner to a cancer patient. In this randomized trial, the investigators aim to assess the potential efficacy of this program in improving the caregiver's resilience and quality of life, as well as reducing symptoms of anxiety, depression and distress. Outcomes will be assessed at baseline and at 3, 6 and 12-months follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Partner/Spouse to a patient diagnosed with Stage I-III cancer and receiving cancer treatment at Herlev Hospital
- •Patient performance status 1 or 2
- •Distress Thermometer score > 4
- •Able to speak and understand Danish
- •Has given written informed consent to participate in the study
Exclusion Criteria
- •Being a cancer patient
- •Has untreated psychopathology or physical impairment that may prevent attendance and participation in the study
- •Active substance abuse
Arms & Interventions
"Resilient Caregivers"
Intervention program
Intervention: "Resilient Caregivers" (Behavioral)
Control group
Care as usual
Intervention: Care as usual (Other)
Outcomes
Primary Outcomes
Change in symptoms of anxiety
Time Frame: Baseline, 3 months, 6 months and 12 months follow-up
Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms
Secondary Outcomes
- Change in perceived stress(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in symptoms of depression(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in valued living(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in resilience(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in rumination/worry and coping(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in psychological distress(Baseline, 3 months, 6 months and 12 months follow-up)
- Change in sleep quality(Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up)
- Change in quality of life(Baseline, 3 months, 6 months and 12 months follow-up)
Investigators
Pernille Bidstrup
Principle investigator
Danish Cancer Society