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

Breast Neoplasms Clinical Trial

Official title:

Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00418444
• Other study ID #: CBCRA#017731
• Status: Completed
• Phase: N/A
• First received: January 2, 2007
• Last updated: June 30, 2015
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: January 2007
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• Group Therapy Intervention

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self image and communication(using standardized instruments)
Secondary	Psychosocial and psychosexual functioning (using standardized instruments)
Secondary	Relational functioning, quality of life and health care utilization (using standardized instruments)