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

April 27, 2021 updated by: Pernille Bidstrup, Danish Cancer Society

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Beverley Lim Høeg, Psychologist
  • Phone Number: +45-35257299
  • Email: bevlim@cancer.dk

Study Contact Backup

  • Name: Peter Genter, Psychologist
  • Phone Number: +45- 70202655
  • Email: petgen@cancer.dk

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: "Resilient Caregivers"
Intervention program
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: Control group
Care as usual
Other: Care as usual
The control arm will receive usual care, which implies no systematic support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months, 6 months and 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, 3 months, 6 months and 12 months follow-up
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
Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Cancer Society

Collaborators

Herlev Hospital

Investigators

  • Principal Investigator: Pernille Envold Bidstrup, Danish Cancer Society Research Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 19, 2021

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

March 1, 2023

Study Registration Dates

First Submitted

September 27, 2020

First Submitted That Met QC Criteria

October 25, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Resilient Caregivers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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