Clinical trial NCT04610034: "Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers
Official title: "Resilient Caregivers" - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distress, Emotional
Keywords: Cancer caregivers
Distress
Anxiety
Resilience
Coping
Lead sponsor: Danish Cancer Society
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2020-10-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in symptoms of anxiety
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
Secondary outcomes:
measure: Change in psychological distress
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in symptoms of depression
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in resilience
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in perceived stress
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in rumination/worry and coping
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in quality of life
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in valued living
timeFrame: Baseline, 3 months, 6 months and 12 months follow-up
measure: Change in sleep quality
timeFrame: Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Danish Cancer Society Research Center
name: Pernille Envold Bidstrup
role: PRINCIPAL_INVESTIGATOR
References:
citation: Genter P, Hoeg BL, Hamre CJ, Andersen EAW, Dalton SO, Ribers B, Bidstrup PE. Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer. BMJ Open. 2021 Nov 12;11(11):e048327. doi: 10.1136/bmjopen-2020-048327.