Know Cancer

forgot password

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

18 Years
65 Years
Open (Enrolling)
Breast Neoplasms

Thank you

Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Outcome Measure:

Self image and communication(using standardized instruments)

Principal Investigator

Mary Jane Esplen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Health Canada

Study ID:




Start Date:

January 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Neoplasms
  • Breast cancer,group psychotherapy,RCT,women's mental health
  • Breast Neoplasms
  • Neoplasms