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OpenTrials
Completed

NCT Number: NCT00418444

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Group Therapy Intervention

Behavioral

Primary outcomes

  1. Self image and communication(using standardized instruments)

Secondary outcomes

  1. Psychosocial and psychosexual functioning (using standardized instruments)

  2. Relational functioning, quality of life and health care utilization (using standardized instruments)

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Sunnybrook Health Sciences Centre

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 4, 2007
Registry last updated
Jul 2, 2015

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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