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Distress, EmotionalNCT04610034

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

A study testing "Resilient Caregivers" and Care as usual in people with Distress, Emotional, run by Danish Cancer Society at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Distress, Emotional
What is being tested?
"Resilient Caregivers" and Care as usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteDenmark
Study dates
19 Mar 2021to Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Beverley Lim Høeg, Psychologist contact

+45-35257299

bevlim@cancer.dk

Peter Genter, Psychologist contact

+45- 70202655

petgen@cancer.dk

Denmark1 site, 1 recruiting

  • Herlev Hospital

    Herlev

    Peter Genter, petgen@cancer.dk

    Recruiting

Other trials in Denmark

About this study

Official title: "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).

Read the 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.

Being tested
"Resilient Caregivers", Care as usual
Keywords
Cancer caregivers, Distress, Anxiety, Resilience, Coping
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • "Resilient Caregivers"Behavioural

    "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.

  • Care as usualOther

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

Study groups in NCT04610034
Study groupRoleWhat they receive
"Resilient Caregivers"ExperimentalIntervention program
Receives: Behavioral: "Resilient Caregivers"
Control groupOtherCare as usual
Receives: Other: Care as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in symptoms of anxiety

    Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms

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

Secondary outcomes (8)

  1. Change in psychological distress

    Measured by the Distress Thermometer; range 0-10; higher scores = higher distress

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

  2. Change in symptoms of depression

    Measured by Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores = more symptoms

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

  3. Change in resilience

    Measured by Connor-Davidson Resilience Scale (CD-RISC-10); range 0-40; higher scores = greater resilience

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

  4. Change in perceived stress

    Measured by Perceived Stress Scale (PSS-10); range 0-40; higher scores = higher perceived stress

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

  5. Change in rumination/worry and coping

    Measured by Cognitive Attentional Syndrome Scale (CAS-1); range 0-100; higher scores = worse rumination/worry and coping

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

  6. 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

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

  7. 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

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

  8. Change in sleep quality

    Measured by the Pittsburg Sleep Quality Index (PSQI); range 0-21; higher scores = worse sleep quality

    Measured: Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start19 Mar 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionMar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04610034
Sponsor's protocol ID
Resilient Caregivers
Status last verified
Apr 2021
First submitted
27 Sep 2020
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hoeg BL, Genter P, Hamre CJ, Rosthoj S, Moller-Jorgensen LS, Dalton SO, Bidstrup PE. "Resilient Caregivers"-A Randomized Trial of a Resilience-Based Intervention for Psychologically Distressed Partner Caregivers of Patients With Cancer. Psychooncology. 2026 Sep;35(9):e70603. doi: 10.1002/pon.70603.

    PubMed 42747116

  • 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.

    PubMed 34772747

Questions about this trial

What is this clinical trial studying?

A study testing "Resilient Caregivers" and Care as usual in people with Distress, Emotional, run by Danish Cancer Society at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beverley Lim Høeg, Psychologist (+45-35257299, bevlim@cancer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in symptoms of anxiety (time frame: Baseline, 3 months, 6 months and 12 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04610034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.

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