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

NCT ID: NCT04610034

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2023-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Distress, Emotional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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"Resilient Caregivers"

Intervention program

Group Type EXPERIMENTAL

"Resilient Caregivers"

Intervention Type BEHAVIORAL

"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

Group Type OTHER

Care as usual

Intervention Type OTHER

The control arm will receive usual care, which implies no systematic support.

Interventions

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"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.

Intervention Type BEHAVIORAL

Care as usual

The control arm will receive usual care, which implies no systematic support.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role collaborator

Danish Cancer Society

OTHER

Sponsor Role lead

Responsible Party

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Pernille Bidstrup

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pernille Envold Bidstrup

Role: PRINCIPAL_INVESTIGATOR

Danish Cancer Society Research Center

Locations

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Herlev Hospital

Herlev, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Beverley Lim Høeg, Psychologist

Role: CONTACT

+45-35257299

Peter Genter, Psychologist

Role: CONTACT

+45- 70202655

Facility Contacts

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Peter Genter

Role: primary

References

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Genter P, Hoeg BL, Hamre CJ, Andersen EAW, Dalton SO, Ribers B, Bidstrup PE. Protocol for 'Resilient Caregivers': a randomised trial of a resilience-based intervention for psychologically distressed partner caregivers of patients with cancer. BMJ Open. 2021 Nov 12;11(11):e048327. doi: 10.1136/bmjopen-2020-048327.

Reference Type DERIVED
PMID: 34772747 (View on PubMed)

Other Identifiers

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Resilient Caregivers

Identifier Type: -

Identifier Source: org_study_id

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