Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-29 @ 3:27 AM
Study NCT ID:
NCT01392066
Status:
COMPLETED
Last Update Posted:
2014-04-23
First Post:
2011-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1584}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-22', 'studyFirstSubmitDate': '2011-07-05', 'studyFirstSubmitQcDate': '2011-07-11', 'lastUpdatePostDateStruct': {'date': '2014-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life', 'timeFrame': 'baseline', 'description': 'self-report questionnaire SF-36'}, {'measure': 'quality of life', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire SF-36'}, {'measure': 'quality of life', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire SF-36'}, {'measure': 'depressive symptoms', 'timeFrame': 'baseline', 'description': 'self-report questionnaire CES-D'}, {'measure': 'depressive symptoms', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire CES-D'}, {'measure': 'depressive symptoms', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire CES-D'}, {'measure': 'dyadic coping', 'timeFrame': 'baseline', 'description': 'self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire'}, {'measure': 'dyadic coping', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire'}, {'measure': 'dyadic coping', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire'}], 'secondaryOutcomes': [{'measure': 'illness perceptions', 'timeFrame': 'baseline', 'description': 'self-report questionnaire Brief-Illness Perception Questionnaire'}, {'measure': 'use of antidepressants', 'timeFrame': '12-months follow up', 'description': 'registry information'}, {'measure': 'work ability', 'timeFrame': 'baseline', 'description': 'self-report item'}, {'measure': 'work ability', 'timeFrame': '5-months follow up', 'description': 'self-report item'}, {'measure': 'work ability', 'timeFrame': '12-months follow up', 'description': 'self-report item'}, {'measure': 'sexual functioning', 'timeFrame': 'baseline', 'description': 'self-report items (PROMIS item bank)'}, {'measure': 'sexual functioning', 'timeFrame': '5-months follow up', 'description': 'self-report items (PROMIS item bank)'}, {'measure': 'sexual functioning', 'timeFrame': '12-months follow up', 'description': 'self-report items (PROMIS item bank)'}, {'measure': 'body image', 'timeFrame': 'baseline', 'description': 'self-report questionnaire Body Image Scale'}, {'measure': 'body image', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire Body Image Scale'}, {'measure': 'body image', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire Body Image Scale'}, {'measure': 'relationship functioning', 'timeFrame': 'baseline', 'description': 'self-report items; quality of relationship and intimacy'}, {'measure': 'relationship functioning', 'timeFrame': '5-months follow up', 'description': 'self-report items; quality of relationship and intimacy'}, {'measure': 'relationship functioning', 'timeFrame': '12-months follow up', 'description': 'self-report items; quality of relationship and intimacy'}, {'measure': 'symptom experience', 'timeFrame': 'baseline', 'description': 'self-report questionnaire BCPT Eight Symptom Scale'}, {'measure': 'symptom experience', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire BCPT Eight Symptom Scale'}, {'measure': 'symptom experience', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire BCPT Eight Symptom Scale'}, {'measure': "partner's involvement in breast cancer", 'timeFrame': 'baseline', 'description': 'self-report questionnaire'}, {'measure': "partner's involvement in breast cancer", 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire'}, {'measure': "partner's involvement in breast cancer", 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire'}, {'measure': 'dimensions of sleep', 'timeFrame': '5-months follow up', 'description': 'self-report questionnaire MOS sleep measure'}, {'measure': 'dimensions of sleep', 'timeFrame': '12-months follow up', 'description': 'self-report questionnaire MOS sleep measure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast neoplasms', 'spouses/partners', 'couples', 'interpersonal relations', 'psychosocial adjustment', 'psychological adaptation', 'depression', 'quality of life', 'dyadic coping', 'coping behavior', 'cohort', 'questionnaire'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to describe psychosocial adjustment in patients with breast cancer and their cohabiting partners/spouses throughout the cancer trajectory, to study mutual influences of the partner on the patient and vice versa, and to identify risk and protective factors that influence the adjustment process in both patients and partners. The overall aim is to generate knowledge that helps enables us to integrate the partners' needs, problems and resources in treatment and rehabilitation of breast cancer patients.", 'detailedDescription': "Breast cancer is a major life event. A patient's experience of breast cancer may depend heavily on her intimate partner. However, both patients and partners may experience depressed mood or other psychosocial adjustment problems. Individual and relationship factors, such as the couple's joint efforts to deal with the cancer experience, are likely to contribute to their psychosocial adjustment. More knowledge is needed on the adjustment problems patients and partners experience and how they deal with them.\n\nThe study investigates the following research questions:\n\n* Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?\n* To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?\n* Which factors are associated with psychosocial adjustment problems?\n* How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?\n\nA prospective, population-based cohort will be established of women diagnosed with breast cancer in Denmark and their partners. The study combines questionnaire data and data from nationwide clinical and administrative registries.\n\nAn invitation letter and study material will be sent to patients by mail. Patients will be asked to invite their partner to participate in the study. Only couples in which both the patient and the partner wish to participate will be asked to complete the questionnaire at 5 and 12 months of follow-up.\n\nUp to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For patients: being a female patient diagnosed with primary breast cancer within the last four months\n* For patients: cohabiting with a male partner/spouse\n* For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months\n\nExclusion Criteria:\n\n* For patients: previous diagnosis of breast cancer or breast cancer relapse'}, 'identificationModule': {'nctId': 'NCT01392066', 'briefTitle': 'Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'SDU-NFK-FK-2011'}, 'secondaryIdInfos': [{'id': 'R40-A1920', 'type': 'OTHER_GRANT', 'domain': 'Danish Cancer Society'}, {'id': '2010-41-5193', 'type': 'OTHER', 'domain': 'Danish Data Protection Agency'}, {'id': '2012-41-0901', 'type': 'OTHER', 'domain': 'new ID from the Danish Data Protection Agency'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast cancer patients and their partners', 'description': 'Patients with breast cancer and their cohabiting partners/spouses', 'interventionNames': ['Behavioral: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'BEHAVIORAL', 'description': 'Both the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes.\n\nThe questionnaire is administered at baseline and 5- and 12-months follow up.', 'armGroupLabels': ['Breast cancer patients and their partners']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Southern Denmark', 'country': 'Denmark', 'facility': 'University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Dorte Gilså Hansen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Unit of General Practice, Institute of Public Health, University of Southern Denmark'}, {'name': 'Christoffer Johansen, MD, PhD, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Institute of Cancer Epidemiology, Danish Cancer Society'}, {'name': 'Mariet Hagedoorn, MSc, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Nina Rottmann, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Unit of General Practice, Institute of Public Health, University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Danish Cancer Society', 'class': 'OTHER'}, {'name': 'University of Groningen', 'class': 'OTHER'}, {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, {'name': 'Herlev Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc', 'investigatorFullName': 'Nina Rottmann', 'investigatorAffiliation': 'University of Southern Denmark'}}}}