Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 10:49 PM
Study NCT ID:
NCT04610034
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2020-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2020-09-27', 'studyFirstSubmitQcDate': '2020-10-25', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in symptoms of anxiety', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by Generalized Anxiety Disorder-7 (GAD-7); range 0-21; higher scores = more symptoms'}], 'secondaryOutcomes': [{'measure': 'Change in psychological distress', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by the Distress Thermometer; range 0-10; higher scores = higher distress'}, {'measure': 'Change in symptoms of depression', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by Patient Health Questionnaire-9 (PHQ-9); range 0-27; higher scores = more symptoms'}, {'measure': 'Change in resilience', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by Connor-Davidson Resilience Scale (CD-RISC-10); range 0-40; higher scores = greater resilience'}, {'measure': 'Change in perceived stress', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by Perceived Stress Scale (PSS-10); range 0-40; higher scores = higher perceived stress'}, {'measure': 'Change in rumination/worry and coping', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by Cognitive Attentional Syndrome Scale (CAS-1); range 0-100; higher scores = worse rumination/worry and coping'}, {'measure': 'Change in quality of life', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by World Health Organization-5 Well-being Index (WHO-5); range 0-25; higher scores = better quality of life'}, {'measure': 'Change in valued living', 'timeFrame': 'Baseline, 3 months, 6 months and 12 months follow-up', 'description': 'Measured by the "Obstruction subscale" from the Valuing Questionnaire (VQ); range 0-30; higher scores = more interference with living consistently with one\'s values'}, {'measure': 'Change in sleep quality', 'timeFrame': 'Baseline, after completion of intervention (approximately 3 months from inclusion), 6 months and 12 months follow-up', 'description': 'Measured by the Pittsburg Sleep Quality Index (PSQI); range 0-21; higher scores = worse sleep quality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer caregivers', 'Distress', 'Anxiety', 'Resilience', 'Coping'], 'conditions': ['Distress, Emotional']}, 'referencesModule': {'references': [{'pmid': '34772747', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Partner/Spouse to a patient diagnosed with Stage I-III cancer and receiving cancer treatment at Herlev Hospital\n* Patient performance status 1 or 2\n* Distress Thermometer score \\> 4\n* Able to speak and understand Danish\n* Has given written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Being a cancer patient\n* Has untreated psychopathology or physical impairment that may prevent attendance and participation in the study\n* Active substance abuse'}, 'identificationModule': {'nctId': 'NCT04610034', 'briefTitle': '"Resilient Caregivers" - A Resilience-based Intervention for Distressed Partner Cancer Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Danish Cancer Society'}, 'officialTitle': '"Resilient Caregivers" - A Randomized Controlled Trial of a Resilience-based Intervention for Distressed Partner Caregivers of Cancer Patients', 'orgStudyIdInfo': {'id': 'Resilient Caregivers'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '"Resilient Caregivers"', 'description': 'Intervention program', 'interventionNames': ['Behavioral: "Resilient Caregivers"']}, {'type': 'OTHER', 'label': 'Control group', 'description': 'Care as usual', 'interventionNames': ['Other: Care as usual']}], 'interventions': [{'name': '"Resilient Caregivers"', 'type': 'BEHAVIORAL', 'description': '"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.', 'armGroupLabels': ['"Resilient Caregivers"']}, {'name': 'Care as usual', 'type': 'OTHER', 'description': 'The control arm will receive usual care, which implies no systematic support.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herlev', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Peter Genter', 'role': 'CONTACT', 'email': 'petgen@cancer.dk'}], 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'centralContacts': [{'name': 'Beverley Lim Høeg, Psychologist', 'role': 'CONTACT', 'email': 'bevlim@cancer.dk', 'phone': '+45-35257299'}, {'name': 'Peter Genter, Psychologist', 'role': 'CONTACT', 'email': 'petgen@cancer.dk', 'phone': '+45- 70202655'}], 'overallOfficials': [{'name': 'Pernille Envold Bidstrup', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Cancer Society Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Cancer Society', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Pernille Bidstrup', 'investigatorAffiliation': 'Danish Cancer Society'}}}}