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

Distress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610034
• Other study ID #: Resilient Caregivers
• Status: Recruiting
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: March 2023

Study information

• Verified date: April 2021
• Source: Danish Cancer Society
• Contact: Beverley Lim Høeg, Psychologist
• Phone: +45-35257299
• Email: bevlim[@]cancer.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Distress, Emotional

Intervention

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.

Other:
• Care as usual
The control arm will receive usual care, which implies no systematic support.

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Herlev

Sponsors (2)

Lead Sponsor	Collaborator
Danish Cancer Society	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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