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: November 5, 2013
Last verified: November 2013

July 5, 2011
November 5, 2013
July 2011
July 2013   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01392066 on ClinicalTrials.gov Archive Site
  • 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
  • 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
Not Provided
Not Provided
 
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Breast Cancer
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.

Breast cancer patients and their partners
Patients with breast cancer and their cohabiting partners/spouses
Intervention: Behavioral: questionnaire
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1584
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01392066
SDU-NFK-FK-2011, R40-A1920, 2010-41-5193, 2012-41-0901
No
Nina Rottmann, University of Southern Denmark
University of Southern Denmark
  • Danish Cancer Society
  • University of Groningen
  • Rigshospitalet, Denmark
  • University Hospital Herlev
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
University of Southern Denmark
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP