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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
"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.
The control arm will receive usual care, which implies no systematic support.
Herlev Hospital
Herlev, Denmark
RECRUITINGChange in symptoms of anxiety
Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms
Time frame: Baseline, 3 months, 6 months and 12 months follow-up
Change in psychological distress
Measured by the Distress Thermometer; range 0-10; higher scores = higher distress
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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Time frame: 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
Time frame: 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
Time frame: Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up