"Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers

Not Applicable

• Conditions: Distress, Emotional
• Interventions: Other: Care as usual; Behavioral: "Resilient Caregivers"

• Registration Number: NCT04610034
• Lead Sponsor: Danish Cancer Society

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 Timeline

• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-10-25
• Study First Posted: 2020-10-30
• Study Start: 2021-03-19
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Care as usual	Care as usual
"Resilient Caregivers"	"Resilient Caregivers"	Intervention program

Primary Outcome Measures

Name	Time	Method
Change in symptoms of anxiety	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 Outcome Measures

Name	Time	Method
Change in perceived stress	Baseline, 3 months, 6 months and 12 months follow-up	Measured by Perceived Stress Scale (PSS-10); range 0-40; higher scores = higher perceived stress
Change in symptoms of depression	Baseline, 3 months, 6 months and 12 months follow-up	Measured by Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores = more symptoms
Change in valued living	Baseline, 3 months, 6 months and 12 months follow-up	Measured by the "Obstruction subscale" from the Valuing Questionnaire (VQ); range 0-30; higher scores = more interference with living consistently with one's values
Change in resilience	Baseline, 3 months, 6 months and 12 months follow-up	Measured by Connor-Davidson Resilience Scale (CD-RISC-10); range 0-40; higher scores = greater resilience
Change in rumination/worry and coping	Baseline, 3 months, 6 months and 12 months follow-up	Measured by Cognitive Attentional Syndrome Scale (CAS-1); range 0-100; higher scores = worse rumination/worry and coping
Change in psychological distress	Baseline, 3 months, 6 months and 12 months follow-up	Measured by the Distress Thermometer; range 0-10; higher scores = higher distress
Change in sleep quality	Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up	Measured by the Pittsburg Sleep Quality Index (PSQI); range 0-21; higher scores = worse sleep quality
Change in quality of life	Baseline, 3 months, 6 months and 12 months follow-up	Measured by World Health Organization-5 Well-being Index (WHO-5); range 0-25; higher scores = better quality of life

Trial Locations

Locations (1)

Herlev Hospital; 🇩🇰 Herlev, Denmark