Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

Breast Cancer Clinical Trial

Official title:

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392066
• Other study ID #: SDU-NFK-FK-2011
• Secondary ID: R40-A19202010-41
• Status: Completed
• Phase: N/A
• First received: July 5, 2011
• Last updated: April 22, 2014
• Start date: July 2011
• Est. completion date: October 2013

Study information

• Verified date: April 2014
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Ministry of Interior and Health
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1584
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark	Odense	Southern Denmark

Sponsors (5)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society, Herlev Hospital, Rigshospitalet, Denmark, University of Groningen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	quality of life	self-report questionnaire SF-36	baseline	No
Primary	quality of life	self-report questionnaire SF-36	5-months follow up	No
Primary	quality of life	self-report questionnaire SF-36	12-months follow up	No
Primary	depressive symptoms	self-report questionnaire CES-D	baseline	No
Primary	depressive symptoms	self-report questionnaire CES-D	5-months follow up	No
Primary	depressive symptoms	self-report questionnaire CES-D	12-months follow up	No
Primary	dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	baseline	No
Primary	dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	5-months follow up	No
Primary	dyadic coping	self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire	12-months follow up	No
Secondary	illness perceptions	self-report questionnaire Brief-Illness Perception Questionnaire	baseline	No
Secondary	use of antidepressants	registry information	12-months follow up	No
Secondary	work ability	self-report item	baseline	No
Secondary	work ability	self-report item	5-months follow up	No
Secondary	work ability	self-report item	12-months follow up	No
Secondary	sexual functioning	self-report items (PROMIS item bank)	baseline	No
Secondary	sexual functioning	self-report items (PROMIS item bank)	5-months follow up	No
Secondary	sexual functioning	self-report items (PROMIS item bank)	12-months follow up	No
Secondary	body image	self-report questionnaire Body Image Scale	baseline	No
Secondary	body image	self-report questionnaire Body Image Scale	5-months follow up	No
Secondary	body image	self-report questionnaire Body Image Scale	12-months follow up	No
Secondary	relationship functioning	self-report items; quality of relationship and intimacy	baseline	No
Secondary	relationship functioning	self-report items; quality of relationship and intimacy	5-months follow up	No
Secondary	relationship functioning	self-report items; quality of relationship and intimacy	12-months follow up	No
Secondary	symptom experience	self-report questionnaire BCPT Eight Symptom Scale	baseline	No
Secondary	symptom experience	self-report questionnaire BCPT Eight Symptom Scale	5-months follow up	No
Secondary	symptom experience	self-report questionnaire BCPT Eight Symptom Scale	12-months follow up	No
Secondary	partner's involvement in breast cancer	self-report questionnaire	baseline	No
Secondary	partner's involvement in breast cancer	self-report questionnaire	5-months follow up	No
Secondary	partner's involvement in breast cancer	self-report questionnaire	12-months follow up	No
Secondary	dimensions of sleep	self-report questionnaire MOS sleep measure	5-months follow up	No
Secondary	dimensions of sleep	self-report questionnaire MOS sleep measure	12-months follow up	No