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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Resilient Caregivers - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients

Conditions
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Distress, Emotional

Intervention / Treatment
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* Behavioral: Resilient Caregivers
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resilient Caregivers<br>Intervention program | Behavioral: Resilient Caregivers<br>* Resilient Caregivers is a 7-session group program developed for partner caregivers of patients with cancer (6 weekly sessions and 1 booster session). Each session takes place in groups of approximately 8 participants and lasts for two-and-a-half hours. Sessions 1 to 3 focuses on the caregiver and introduces the resilience components of coping strategies, meta-reflective skill and clarification of values. Sessions 4 and 5 focuses on these components in the relationship between the caregiver and the cancer patient and social support networks respectively, while Session 6 focuses on resilience in relation to self-care and care for the partner. A booster session will be scheduled one month after the end of Session 6 in order to follow-up on the intervention and allow participants to reflect on the benefits and challenges of the program.<br>|
| Other: Control group<br>Care as usual | Other: Care as usual<br>* The control arm will receive usual care, which implies no systematic support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptoms of anxiety | Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms | Baseline, 3 months, 6 months and 12 months follow-up | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer caregivers, Distress, Anxiety, Resilience, Coping