NCT01392066

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,584

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 12, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

April 23, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

July 5, 2011

Last Update Submit

April 22, 2014

Conditions

Breast Cancer

Keywords

breast neoplasmsspouses/partnerscouplesinterpersonal relationspsychosocial adjustmentpsychological adaptationdepressionquality of lifedyadic copingcoping behaviorcohortquestionnaire

Outcome Measures

Primary Outcomes (9)

  • 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 Outcomes (22)

  • illness perceptions

    baseline

  • use of antidepressants

    12-months follow up

  • work ability

    baseline

  • work ability

    5-months follow up

  • work ability

    12-months follow up

  • +17 more secondary outcomes

Study Arms (1)

Breast cancer patients and their partners

Patients with breast cancer and their cohabiting partners/spouses

Behavioral: questionnaire

Interventions

questionnaireBEHAVIORAL

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.

Breast cancer patients and their partners

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • For patients: previous diagnosis of breast cancer or breast cancer relapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern Denmark

Odense, Southern Denmark, 5000, Denmark

Location

MeSH Terms

Conditions

Breast NeoplasmsDepression

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Dorte GilsÃ¥ 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

    STUDY CHAIR

  • Nina Rottmann, MSc

    Research Unit of General Practice, Institute of Public Health, University of Southern Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

July 5, 2011

First Posted

July 12, 2011

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

October 1, 2013

Last Updated

April 23, 2014

Record last verified: 2014-04

Locations

DK(1)