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.

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: questionnaire

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 Type: Observational
• Enrollment (Actual): 1584

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark
    • Odense, Southern Denmark, Denmark, 5000
      • University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast cancer patients and their partners; Patients with breast cancer and their cohabiting partners/spouses	Behavioral: questionnaire; Both 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life	self-report questionnaire SF-36	baseline
quality of life	self-report questionnaire SF-36	5-months follow up
quality of life	self-report questionnaire SF-36	12-months follow up
depressive symptoms	self-report questionnaire CES-D	baseline
depressive symptoms	self-report questionnaire CES-D	5-months follow up
depressive symptoms	self-report questionnaire CES-D	12-months follow up
dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	baseline
dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	5-months follow up
dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	12-months follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
illness perceptions	self-report questionnaire Brief-Illness Perception Questionnaire	baseline
use of antidepressants	registry information	12-months follow up
work ability	self-report item	baseline
work ability	self-report item	5-months follow up
work ability	self-report item	12-months follow up
sexual functioning	self-report items (PROMIS item bank)	baseline
sexual functioning	self-report items (PROMIS item bank)	5-months follow up
sexual functioning	self-report items (PROMIS item bank)	12-months follow up
body image	self-report questionnaire Body Image Scale	baseline
body image	self-report questionnaire Body Image Scale	5-months follow up
body image	self-report questionnaire Body Image Scale	12-months follow up
relationship functioning	self-report items; quality of relationship and intimacy	baseline
relationship functioning	self-report items; quality of relationship and intimacy	5-months follow up
relationship functioning	self-report items; quality of relationship and intimacy	12-months follow up
symptom experience	self-report questionnaire BCPT Eight Symptom Scale	baseline
symptom experience	self-report questionnaire BCPT Eight Symptom Scale	5-months follow up
symptom experience	self-report questionnaire BCPT Eight Symptom Scale	12-months follow up
partner's involvement in breast cancer	self-report questionnaire	baseline
partner's involvement in breast cancer	self-report questionnaire	5-months follow up
partner's involvement in breast cancer	self-report questionnaire	12-months follow up
dimensions of sleep	self-report questionnaire MOS sleep measure	5-months follow up
dimensions of sleep	self-report questionnaire MOS sleep measure	12-months follow up

Collaborators and Investigators

• Sponsor: University of Southern Denmark
• Collaborators: Rigshospitalet, Denmark; Danish Cancer Society; Herlev Hospital; University of Groningen
• Investigators: Study Chair: Dorte Gilså Hansen, MD, PhD, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark; Study Chair: Christoffer Johansen, MD, PhD, DMSc, Institute of Cancer Epidemiology, Danish Cancer Society; Study Chair: Mariet Hagedoorn, MSc, PhD, University Medical Center Groningen; Principal Investigator: Nina Rottmann, MSc, Research Unit of General Practice, Institute of Public Health, University of Southern Denmark

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): April 23, 2014
• Last Update Submitted That Met QC Criteria: April 22, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: quality of life; depression; breast neoplasms; questionnaire; cohort; psychosocial adjustment; couples; coping behavior; psychological adaptation; spouses/partners; interpersonal relations; dyadic coping
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SDU-NFK-FK-2011; R40-A1920 (Other Grant/Funding Number: Danish Cancer Society); 2010-41-5193 (Other Identifier: Danish Data Protection Agency); 2012-41-0901 (Other Identifier: new ID from the Danish Data Protection Agency)