Clinical Trials Directory

Trials / Completed

CompletedNCT01392066

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

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

Status
Completed
Phase
Study type
Observational
Enrollment
1,584 (actual)
Sponsor
University of Southern Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALquestionnaireBoth 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.

Timeline

Start date
2011-07-01
Primary completion
2013-07-01
Completion
2013-10-01
First posted
2011-07-12
Last updated
2014-04-23

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01392066. Inclusion in this directory is not an endorsement.