"Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers
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|ClinicalTrials.gov Identifier: NCT04610034|
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : April 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Distress, Emotional||Behavioral: "Resilient Caregivers" Other: Care as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||"Resilient Caregivers" - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients|
|Actual Study Start Date :||March 19, 2021|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||March 2023|
Experimental: "Resilient Caregivers"
Behavioral: "Resilient Caregivers"
"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.
Care as usual
Other: Care as usual
The control arm will receive usual care, which implies no systematic support.
- 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
- Change in psychological distress [ Time Frame: Baseline, 3 months, 6 months and 12 months follow-up ]Measured by the Distress Thermometer; range 0-10; higher scores = higher distress
- Change in symptoms of depression [ Time Frame: 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 resilience [ Time Frame: 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 perceived stress [ Time Frame: 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 rumination/worry and coping [ Time Frame: 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 quality of life [ Time Frame: 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
- Change in valued living [ Time Frame: 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 sleep quality [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610034
|Contact: Beverley Lim Høeg, Psychologistemail@example.com|
|Contact: Peter Genter, Psychologist||+45- firstname.lastname@example.org|
|Contact: Peter Genter email@example.com|
|Principal Investigator:||Pernille Envold Bidstrup||Danish Cancer Society Research Center|