Body Image and Psychosocial Functioning in Women With Breast Cancer: Can We Fix What We've Broken?

Not Applicable

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT00418444
• Lead Sponsor: University Health Network, Toronto

Brief Summary

The purpose of this study is to test an innovative intervention geared towards issues of identity, body image and sexuality, and to examine the intervention for its impact on body image, quality of life, psychosocial/sexuality/relational functioning.

Detailed Description

Breast cancer is the most frequently diagnosed cancer in women with 1 in 10 Canadian women being diagnosed in their lifetime. There has been an increase in the number of survivors due to advances in treatment and early detection, and increased scientific attention has been focused on patients' quality of life during and after treatment. The majority of survivors do well after the initial adjustment within the first 2 years post-treatment. However, depending on when assessed after treatment completion, a wide range of cancer survivors either score at levels suggestive of a psychiatric diagnosis or are diagnosed with a psychological problem. Furthermore, a subset of survivors experience adjustment problems long after treatment completion. Approximately 20% to 40% of survivors develop sexual and body image problems following breast cancer and treatment and these difficulties tend to persist several years after treatment completion.

This study aims to test an innovative intervention geared towards issues of identity, body image and sexuality and to examine the intervention for its impact on body image and quality of life, psychosocial and sexual functioning and relational functioning.

One hundred and eighty women who have completed treatment for breast cancer will be randomized into either intervention: an 8 weekly psychosocial group support or control condition (standard care + written educational material). All subjects will be followed for 1 year post-intervention. It is hypothesized that, compared to control subjects who receive standard care and educational materials, subjects participating in an 8 weekly psychosocial group support will have higher levels of relationship support/functioning, and that the group differences will be maintained over the 1-year follow up period.

Study Timeline

• Status Verified: 2007-01
• Study Start: 2007-01
• Study First Submitted: 2007-01-02
• Study First Submitted QC: 2007-01-02
• Study First Posted: 2007-01-04
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• women with primary breast cancer
• age between 18 and 65 years
• completed adjuvant treatments
• Stage I,II,III cancer of the breast with no metastatic disease

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Exclusion Criteria

• presence of any metastases
• history of major psychiatric disorder as defined by the DSM-IV
• inability to speak or read English for questionnaire completion
• failure to provide informed consent
• currently participating in a therapist-led psychosocial support group

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self image and communication(using standardized instruments)

Secondary Outcome Measures

Name	Time	Method
Psychosocial and psychosexual functioning (using standardized instruments)
Relational functioning, quality of life and health care utilization (using standardized instruments)

Trial Locations

Locations (2)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada