Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT01392066
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.
Study:
NCT01392066
Study Brief:
Protocol Section:
NCT01392066