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Clinical Trials/NCT01392066
NCT01392066
Completed
Not Applicable

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.

University of Southern Denmark1 site in 1 country1,584 target enrollmentJuly 2011
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Southern Denmark
Enrollment
1584
Locations
1
Primary Endpoint
depressive symptoms
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Detailed Description

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. 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.

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
October 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nina Rottmann

MSc

University of Southern Denmark

Eligibility Criteria

Inclusion Criteria

  • For patients: being a female patient diagnosed with primary breast cancer within the last four months
  • 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

  • For patients: previous diagnosis of breast cancer or breast cancer relapse

Outcomes

Primary Outcomes

depressive symptoms

Time Frame: 12-months follow up

self-report questionnaire CES-D

quality of life

Time Frame: 12-months follow up

self-report questionnaire SF-36

dyadic coping

Time Frame: 12-months follow up

self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

Secondary Outcomes

  • sexual functioning(12-months follow up)
  • body image(12-months follow up)
  • relationship functioning(12-months follow up)
  • symptom experience(12-months follow up)
  • work ability(12-months follow up)
  • partner's involvement in breast cancer(12-months follow up)
  • illness perceptions(baseline)
  • use of antidepressants(12-months follow up)
  • dimensions of sleep(12-months follow up)

Study Sites (1)

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