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Completed

NCT Number: NCT01392066

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern Denmark

Odense, Southern Denmark, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Behavioral

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Danish Cancer Society
  • Herlev Hospital
  • Rigshospitalet, Denmark
  • University of Groningen

Registry information

Official study title

Psychosocial Adjustment of Patients and Their Partners Following Breast Cancer Diagnosis. A Prospective Cohort Study.

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 12, 2011
Registry last updated
Apr 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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