Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

This study has been completed.
Sponsor:
Collaborators:
Danish Cancer Society
University of Groningen
Rigshospitalet, Denmark
University Hospital Herlev
Information provided by (Responsible Party):
Nina Rottmann, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01392066
First received: July 5, 2011
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • quality of life [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire SF-36

  • quality of life [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire SF-36

  • quality of life [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire SF-36

  • depressive symptoms [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire CES-D

  • depressive symptoms [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire CES-D

  • depressive symptoms [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire CES-D

  • dyadic coping [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

  • dyadic coping [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

  • dyadic coping [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire


Secondary Outcome Measures:
  • illness perceptions [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire Brief-Illness Perception Questionnaire

  • use of antidepressants [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    registry information

  • work ability [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report item

  • work ability [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report item

  • work ability [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report item

  • sexual functioning [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report items (PROMIS item bank)

  • sexual functioning [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report items (PROMIS item bank)

  • sexual functioning [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report items (PROMIS item bank)

  • body image [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire Body Image Scale

  • body image [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire Body Image Scale

  • body image [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire Body Image Scale

  • relationship functioning [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report items; quality of relationship and intimacy

  • relationship functioning [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report items; quality of relationship and intimacy

  • relationship functioning [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report items; quality of relationship and intimacy

  • symptom experience [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire BCPT Eight Symptom Scale

  • symptom experience [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire BCPT Eight Symptom Scale

  • symptom experience [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire BCPT Eight Symptom Scale

  • partner's involvement in breast cancer [ Time Frame: baseline ] [ Designated as safety issue: No ]
    self-report questionnaire

  • partner's involvement in breast cancer [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire

  • partner's involvement in breast cancer [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire

  • dimensions of sleep [ Time Frame: 5-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire MOS sleep measure

  • dimensions of sleep [ Time Frame: 12-months follow up ] [ Designated as safety issue: No ]
    self-report questionnaire MOS sleep measure


Enrollment: 1584
Study Start Date: July 2011
Study Completion Date: October 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392066

Locations
Denmark
University of Southern Denmark
Odense, Southern Denmark, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Danish Cancer Society
University of Groningen
Rigshospitalet, Denmark
University Hospital Herlev
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 Centre Groningen
Principal Investigator: Nina Rottmann, MSc Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
  More Information

No publications provided

Responsible Party: Nina Rottmann, MSc, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01392066     History of Changes
Other Study ID Numbers: SDU-NFK-FK-2011, R40-A1920, 2010-41-5193, 2012-41-0901
Study First Received: July 5, 2011
Last Updated: April 22, 2014
Health Authority: Denmark: The Ministry of Interior and Health

Keywords provided by University of Southern Denmark:
breast neoplasms
spouses/partners
couples
interpersonal relations
psychosocial adjustment
psychological adaptation
depression
quality of life
dyadic coping
coping behavior
cohort
questionnaire

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014