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Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

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ClinicalTrials.gov Identifier: NCT01392066
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : April 23, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Breast Cancer Behavioral: questionnaire

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.


Study Design

Study Type : Observational
Actual Enrollment : 1584 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.
Study Start Date : July 2011
Primary Completion Date : July 2013
Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.



Outcome Measures

Primary Outcome Measures :
  1. quality of life [ Time Frame: baseline ]
    self-report questionnaire SF-36

  2. quality of life [ Time Frame: 5-months follow up ]
    self-report questionnaire SF-36

  3. quality of life [ Time Frame: 12-months follow up ]
    self-report questionnaire SF-36

  4. depressive symptoms [ Time Frame: baseline ]
    self-report questionnaire CES-D

  5. depressive symptoms [ Time Frame: 5-months follow up ]
    self-report questionnaire CES-D

  6. depressive symptoms [ Time Frame: 12-months follow up ]
    self-report questionnaire CES-D

  7. dyadic coping [ Time Frame: baseline ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

  8. dyadic coping [ Time Frame: 5-months follow up ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire

  9. dyadic coping [ Time Frame: 12-months follow up ]
    self-report questionnaire, Dyadic Coping Inventory and Ways of Providing Support Questionnaire


Secondary Outcome Measures :
  1. illness perceptions [ Time Frame: baseline ]
    self-report questionnaire Brief-Illness Perception Questionnaire

  2. use of antidepressants [ Time Frame: 12-months follow up ]
    registry information

  3. work ability [ Time Frame: baseline ]
    self-report item

  4. work ability [ Time Frame: 5-months follow up ]
    self-report item

  5. work ability [ Time Frame: 12-months follow up ]
    self-report item

  6. sexual functioning [ Time Frame: baseline ]
    self-report items (PROMIS item bank)

  7. sexual functioning [ Time Frame: 5-months follow up ]
    self-report items (PROMIS item bank)

  8. sexual functioning [ Time Frame: 12-months follow up ]
    self-report items (PROMIS item bank)

  9. body image [ Time Frame: baseline ]
    self-report questionnaire Body Image Scale

  10. body image [ Time Frame: 5-months follow up ]
    self-report questionnaire Body Image Scale

  11. body image [ Time Frame: 12-months follow up ]
    self-report questionnaire Body Image Scale

  12. relationship functioning [ Time Frame: baseline ]
    self-report items; quality of relationship and intimacy

  13. relationship functioning [ Time Frame: 5-months follow up ]
    self-report items; quality of relationship and intimacy

  14. relationship functioning [ Time Frame: 12-months follow up ]
    self-report items; quality of relationship and intimacy

  15. symptom experience [ Time Frame: baseline ]
    self-report questionnaire BCPT Eight Symptom Scale

  16. symptom experience [ Time Frame: 5-months follow up ]
    self-report questionnaire BCPT Eight Symptom Scale

  17. symptom experience [ Time Frame: 12-months follow up ]
    self-report questionnaire BCPT Eight Symptom Scale

  18. partner's involvement in breast cancer [ Time Frame: baseline ]
    self-report questionnaire

  19. partner's involvement in breast cancer [ Time Frame: 5-months follow up ]
    self-report questionnaire

  20. partner's involvement in breast cancer [ Time Frame: 12-months follow up ]
    self-report questionnaire

  21. dimensions of sleep [ Time Frame: 5-months follow up ]
    self-report questionnaire MOS sleep measure

  22. dimensions of sleep [ Time Frame: 12-months follow up ]
    self-report questionnaire MOS sleep measure


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Herlev Hospital
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 Center Groningen
Principal Investigator: Nina Rottmann, MSc Research Unit of General Practice, Institute of Public Health, University of Southern Denmark
More Information

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 ( Other Grant/Funding Number: Danish Cancer Society )
2010-41-5193 ( Other Identifier: Danish Data Protection Agency )
2012-41-0901 ( Other Identifier: new ID from the Danish Data Protection Agency )
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014

Keywords provided by Nina Rottmann, 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