NCT04610034

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

1.7 years

First QC Date

September 27, 2020

Last Update Submit

April 27, 2021

Conditions

Distress, Emotional

Keywords

Cancer caregiversDistressAnxietyResilienceCoping

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Change in psychological distress

    Baseline, 3 months, 6 months and 12 months follow-up

  • Change in symptoms of depression

    Baseline, 3 months, 6 months and 12 months follow-up

  • Change in resilience

    Baseline, 3 months, 6 months and 12 months follow-up

  • Change in perceived stress

    Baseline, 3 months, 6 months and 12 months follow-up

  • Change in rumination/worry and coping

    Baseline, 3 months, 6 months and 12 months follow-up

  • +3 more secondary outcomes

Study Arms (2)

"Resilient Caregivers"

EXPERIMENTAL

Intervention program

Behavioral: "Resilient Caregivers"

Control group

OTHER

Care as usual

Other: Care as usual

Interventions

"Resilient Caregivers"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.

"Resilient Caregivers"
Care as usualOTHER

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Being a cancer patient
  • Has untreated psychopathology or physical impairment that may prevent attendance and participation in the study
  • Active substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herlev Hospital

Herlev, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34772747DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Pernille Envold Bidstrup

    Danish Cancer Society Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverley Lim Høeg, Psychologist

CONTACT

+45-35257299bevlim@cancer.dk

Peter Genter, Psychologist

CONTACT

+45- 70202655petgen@cancer.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

September 27, 2020

First Posted

October 30, 2020

Study Start

March 19, 2021

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)