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"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
Sponsor:
Collaborator:
Herlev Hospital
Information provided by (Responsible Party):
Pernille Bidstrup, Danish Cancer Society

Brief 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).

Condition or disease Intervention/treatment Phase
Distress, Emotional Behavioral: "Resilient Caregivers" Other: Care as usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers

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.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Beverley Lim Høeg, Psychologist +45-35257299 bevlim@cancer.dk
Contact: Peter Genter, Psychologist +45- 70202655 petgen@cancer.dk

Locations
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Denmark
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Peter Genter       petgen@cancer.dk   
Sponsors and Collaborators
Danish Cancer Society
Herlev Hospital
Investigators
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Principal Investigator: Pernille Envold Bidstrup Danish Cancer Society Research Center
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Responsible Party: Pernille Bidstrup, Principle investigator, Danish Cancer Society
ClinicalTrials.gov Identifier: NCT04610034    
Other Study ID Numbers: Resilient Caregivers
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pernille Bidstrup, Danish Cancer Society:
Cancer caregivers
Distress
Anxiety
Resilience
Coping