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A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer

Phase 3
18 Years
70 Years
Not Enrolling
Breast Neoplasms

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Trial Information

A Randomized Controlled Trial of a Group Intervention for Women With a Family History of Breast Cancer

Keywords: Breast cancer, genetics, psychotherapy, group counselling, randomized control
trial, risk counselling, women's mental health, familial breast cancer.

One in 10 Canadian women will be diagnosed with breast cancer (BC) and approximately 5% of
all BC is believed to be hereditary. Women with a family history of BC experience high
levels of perceived risk and vulnerability for developing BC. Elevated risk perceptions for
BC are difficult to modify and have been associated with psychological distress that, in
turn, can interfere with screening adherence. The specific objectives of the current
randomized trial are to determine the effects of a supportive-expressive group intervention
on a) psychosocial functioning (using standardized instruments), b) BC risk/genetic
knowledge and c) screening behaviors in women with a family history of breast cancer
receiving standard genetic risk counseling. Preliminary data will be collected to examine
the cost effectiveness of the intervention.

The study is being conducted in the following University of Toronto affiliated teaching
hospitals: Mount Sinai Hospital; Preventive Oncology Program, Sunnybrook and Women's College
Health Sciences; Toronto Sunnybrook Regional Cancer Centre; University Health Network; North
York General Hospital; Credit Valley Hospital. A total of 150 women with a family history of
BC will be randomized in a ratio of 2 to 1 to participate in an 8 weekly/ 4 monthly support
group or to a control arm that receives educational materials.

The study has been funded by the Canadian Breast Cancer Research Initiative (CBCRI) of the
National Cancer Institute of Canada since 2001. To date 66 women have been enrolled in the
study and we anticipate a total of 90 women will be enrolled by the end of the current
funding year in June 2004. At this rate it is expected that recruitment will be completed in
June 2005, the last intervention groups will be completed by January 2006 and that analysis
of the final study results will be completed by June 2006. Analysis of baseline data will
begin in September 2005 once the last study groups have been initiated and a manuscript
reporting the final results will be prepared by June 2006. Two years of funding is requested
for these activities.

Significance: Technological advances in molecular biology and genetics are occurring
rapidly. Our proposed research has direct relevance for advancing knowledge on the
communication and provision of risk/genetic information to individuals with a family history
of BC and has both direct and indirect relevance to individuals at all stages of cancer.
Improved counselling techniques for those with a family history may impact on the prevention
and management of BC through improved surveillance and preventive techniques, enhanced
psychosocial functioning and wellbeing through increased psychological resilience. In
addition, effective risk counselling interventions may facilitate the understanding of and
decision-making around genetic testing, and the adjustment to a cancer diagnosis, should
these women with family histories later develop the disease.

Inclusion Criteria:

- at least one 1st-degree relative with Breast Cancer

- age 18-70 years

- live within one hour of downtown Toronto

- score higher than 15 in Breast Cancer Anxiety Scale (BCAS)

Exclusion Criteria:

- Carrier status for genetic mutation (i.e. BRCA1) known

- Previous diagnosis of breast cancer or other malignancy (other than non-melanoma
skin cancer)

- History of major psychiatric disorder, such as schizophrenia, active psychosis,
untreated major depression, as defined in the DSM IV and obtained through a
semi-structured psychiatric interview

- Failure to provide informed consent

Type of Study:


Study Design:

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

Outcome Measure:

Psychosocial functioning (using standardized instruments)

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Mary Jane Esplen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Toronto


Canada: Ethics Review Committee

Study ID:




Start Date:

July 2001

Completion Date:

January 2007

Related Keywords:

  • Breast Neoplasms
  • Breast cancer
  • Genetics
  • Psychotherapy
  • Group counselling
  • Randomized control trial
  • Risk counselling
  • Women's mental health
  • Familial breast cancer
  • Breast Neoplasms
  • Neoplasms