Clinical trial NCT01392066: Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis
Official title: Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast neoplasms
spouses/partners
couples
interpersonal relations
psychosocial adjustment
psychological adaptation
depression
quality of life
dyadic coping
coping behavior
cohort
questionnaire
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Danish Cancer Society
name: University of Groningen
name: Rigshospitalet, Denmark
name: Herlev Hospital
First posted: 2011-07-12
Enrollment: 1584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: nationwide, population-based cohort of women diagnosed with breast cancer and their male cohabiting partner/spouse

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.

Eligibility criteria: 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

Primary outcomes:
measure: quality of life
timeFrame: baseline
measure: quality of life
timeFrame: 5-months follow up
measure: quality of life
timeFrame: 12-months follow up
measure: depressive symptoms
timeFrame: baseline
measure: depressive symptoms
timeFrame: 5-months follow up
measure: depressive symptoms
timeFrame: 12-months follow up
measure: dyadic coping
timeFrame: baseline
measure: dyadic coping
timeFrame: 5-months follow up
measure: dyadic coping
timeFrame: 12-months follow up
Secondary outcomes:
measure: illness perceptions
timeFrame: baseline
measure: use of antidepressants
timeFrame: 12-months follow up
measure: work ability
timeFrame: baseline
measure: work ability
timeFrame: 5-months follow up
measure: work ability
timeFrame: 12-months follow up
measure: sexual functioning
timeFrame: baseline
measure: sexual functioning
timeFrame: 5-months follow up
measure: sexual functioning
timeFrame: 12-months follow up
measure: body image
timeFrame: baseline
measure: body image
timeFrame: 5-months follow up
measure: body image
timeFrame: 12-months follow up
measure: relationship functioning
timeFrame: baseline
measure: relationship functioning
timeFrame: 5-months follow up
measure: relationship functioning
timeFrame: 12-months follow up
measure: symptom experience
timeFrame: baseline
measure: symptom experience
timeFrame: 5-months follow up
measure: symptom experience
timeFrame: 12-months follow up
measure: partner's involvement in breast cancer
timeFrame: baseline
measure: partner's involvement in breast cancer
timeFrame: 5-months follow up
measure: partner's involvement in breast cancer
timeFrame: 12-months follow up
measure: dimensions of sleep
timeFrame: 5-months follow up
measure: dimensions of sleep
timeFrame: 12-months follow up
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: University of Southern Denmark
state: Southern Denmark
Study officials:
affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
name: Dorte Gilså Hansen, MD, PhD
role: STUDY_CHAIR
affiliation: Institute of Cancer Epidemiology, Danish Cancer Society
name: Christoffer Johansen, MD, PhD, DMSc
role: STUDY_CHAIR
affiliation: University Medical Center Groningen
name: Mariet Hagedoorn, MSc, PhD
role: STUDY_CHAIR
affiliation: Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
name: Nina Rottmann, MSc
role: PRINCIPAL_INVESTIGATOR
References: