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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.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01392066
Enrollment
1584
Registered
2011-07-12
Start date
2011-07-31
Completion date
2013-10-31
Last updated
2014-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BEHAVIORALquestionnaire

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.

Sponsors

Danish Cancer Society
CollaboratorOTHER
University of Groningen
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Herlev Hospital
CollaboratorOTHER
University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
quality of lifebaselineself-report questionnaire SF-36
depressive symptomsbaselineself-report questionnaire CES-D
dyadic copingbaselineself-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

Secondary

MeasureTime frameDescription
work abilitybaselineself-report item
sexual functioningbaselineself-report items (PROMIS item bank)
relationship functioningbaselineself-report items; quality of relationship and intimacy
body imagebaselineself-report questionnaire Body Image Scale
partner's involvement in breast cancerbaselineself-report questionnaire
dimensions of sleep5-months follow upself-report questionnaire MOS sleep measure
symptom experiencebaselineself-report questionnaire BCPT Eight Symptom Scale
illness perceptionsbaselineself-report questionnaire Brief-Illness Perception Questionnaire
use of antidepressants12-months follow upregistry information

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026