Body Image and Psychosocial Functioning in Women With Breast Cancer: Can We Fix What We've Broken?
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|ClinicalTrials.gov Identifier: NCT00418444|
Recruitment Status : Completed
First Posted : January 4, 2007
Last Update Posted : July 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Behavioral: Group Therapy Intervention||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
- Self image and communication(using standardized instruments)
- Psychosocial and psychosexual functioning (using standardized instruments)
- Relational functioning, quality of life and health care utilization (using standardized instruments)
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): NCT00418444
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Mary Jane Esplen, PhD||University Health Network, Toronto|