Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis
NCT ID: NCT01392066
Last Updated: 2014-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1584 participants
OBSERVATIONAL
2011-07-31
2013-10-31
Brief Summary
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Detailed Description
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The study investigates the following research questions:
* Which psychosocial adjustment problems do patients and partners experience throughout the cancer trajectory?
* To what extent do the patient's psychosocial adjustment problems influence the partner's psychosocial adjustment problems and vice versa?
* Which factors are associated with psychosocial adjustment problems?
* How do different strategies of dyadic coping influence the psychosocial adjustment of both the patient and the partner?
A 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.
An 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.
Up to 3000 couples (3000 patients and 3000 partners) will be asked to participate in the study during the one year inclusion period.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Breast cancer patients and their partners
Patients with breast cancer and their cohabiting partners/spouses
questionnaire
Both the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes.
The questionnaire is administered at baseline and 5- and 12-months follow up.
Interventions
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questionnaire
Both the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes.
The questionnaire is administered at baseline and 5- and 12-months follow up.
Eligibility Criteria
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Inclusion Criteria
* For patients: cohabiting with a male partner/spouse
* For partners: being the male cohabiting partner/spouse of a patient diagnosed with primary breast cancer within the last four months
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Danish Cancer Society
OTHER
University of Groningen
OTHER
Rigshospitalet, Denmark
OTHER
Herlev Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Nina Rottmann
MSc
Principal Investigators
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Dorte Gilså Hansen, MD, PhD
Role: STUDY_CHAIR
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
Christoffer Johansen, MD, PhD, DMSc
Role: STUDY_CHAIR
Institute of Cancer Epidemiology, Danish Cancer Society
Mariet Hagedoorn, MSc, PhD
Role: STUDY_CHAIR
University Medical Center Groningen
Nina Rottmann, MSc
Role: PRINCIPAL_INVESTIGATOR
Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
Locations
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University of Southern Denmark
Odense, Southern Denmark, Denmark
Countries
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Other Identifiers
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R40-A1920
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2010-41-5193
Identifier Type: OTHER
Identifier Source: secondary_id
2012-41-0901
Identifier Type: OTHER
Identifier Source: secondary_id
SDU-NFK-FK-2011
Identifier Type: -
Identifier Source: org_study_id
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