An interventional study of "Resilient Caregivers" and Care as usual in Distress, Emotional, sponsored by Danish Cancer Society. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-28.
Sponsored by Danish Cancer Society · Not applicable, Interventional, and Treatment
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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.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 80 is close to the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Danish Cancer Society is the lead sponsor of 22 studies on the registry; none are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention program
Behavioral: "Resilient Caregivers"
Care as usual
Other: Care as usual
"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.
The control arm will receive usual care, which implies no systematic support.
Change in symptoms of anxiety
Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms
Time frame: Baseline, 3 months, 6 months and 12 months follow-up
Change in psychological distress
Measured by the Distress Thermometer; range 0-10; higher scores = higher distress
Time frame: Baseline, 3 months, 6 months and 12 months follow-up
Change in symptoms of depression
Measured by Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores = more symptoms
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up
Plan to share: No
Started Mar 2021 (actual). Primary completion is estimated for Dec 2022, 21 months after the start.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 21 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Danish Cancer Society