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| Name | Class |
|---|---|
| Herlev Hospital | OTHER |
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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).
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Resilient Caregivers" | Experimental | Intervention program |
|
| Control group | Other | Care as usual |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in psychological distress | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beverley Lim Høeg, Psychologist | Contact | +45-35257299 | bevlim@cancer.dk | |
| Peter Genter, Psychologist | Contact | +45- 70202655 | petgen@cancer.dk |
| Name | Affiliation | Role |
|---|---|---|
| Pernille Envold Bidstrup | Danish Cancer Society Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev Hospital | Recruiting | Herlev | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34772747 | Derived | 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. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Care as usual | Other | The control arm will receive usual care, which implies no systematic support. |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 |