MedPath

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

Completed
Conditions
Breast Cancer
Interventions
Behavioral: questionnaire
Registration Number
NCT01392066
Lead Sponsor
University of Southern Denmark
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1584
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Breast cancer patients and their partnersquestionnairePatients with breast cancer and their cohabiting partners/spouses
Primary Outcome Measures
NameTimeMethod
quality of life12-months follow up

self-report questionnaire SF-36

depressive symptoms12-months follow up

self-report questionnaire CES-D

dyadic coping12-months follow up

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

Secondary Outcome Measures
NameTimeMethod
sexual functioning12-months follow up

self-report items (PROMIS item bank)

work ability12-months follow up

self-report item

body image12-months follow up

self-report questionnaire Body Image Scale

relationship functioning12-months follow up

self-report items; quality of relationship and intimacy

symptom experience12-months follow up

self-report questionnaire BCPT Eight Symptom Scale

partner's involvement in breast cancer12-months follow up

self-report questionnaire

illness perceptionsbaseline

self-report questionnaire Brief-Illness Perception Questionnaire

use of antidepressants12-months follow up

registry information

dimensions of sleep12-months follow up

self-report questionnaire MOS sleep measure

Trial Locations

Locations (1)

University of Southern Denmark

🇩🇰

Odense, Southern Denmark, Denmark

© Copyright 2025. All Rights Reserved by MedPath