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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sunnybrook Health Sciences Centre
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00418444
First received: January 2, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Neoplasms
Behavioral: Group Therapy Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: Randomized Control Trial of a Group Therapy Intervention Addressing Body Image and Psychosocial Functioning for Women With Breast Cancer

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Self image and communication(using standardized instruments)

Secondary Outcome Measures:
  • Psychosocial and psychosexual functioning (using standardized instruments)
  • Relational functioning, quality of life and health care utilization (using standardized instruments)

Estimated Enrollment: 180
Study Start Date: January 2007
Estimated Study Completion Date: December 2009
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00418444

Contacts
Contact: Mary Jane Esplen, PhD (416)340-3024 mesplen@uhnres.utoronto.ca
Contact: Susan Clarke, RN, MN (416)340-4800 ext 6269 sclarke@uhnres.utoronto.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Susan Clarke, RN, MN    (416)340-4800 ext 6269    sclarke@uhnres.utoronto.ca   
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Karen Fergus, PhD    (416)480-5000 ext 1243    karen.fergus@sunnybrook.ca   
Sponsors and Collaborators
University Health Network, Toronto
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Mary Jane Esplen, PhD University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00418444     History of Changes
Other Study ID Numbers: CBCRA#017731
Study First Received: January 2, 2007
Last Updated: January 2, 2007
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Breast cancer,group psychotherapy,RCT,women's mental health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 11, 2014