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:
University of Southern Denmark
Organization:
Study Overview
Official Title:
Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: