RCT of a Group Intervention for Women With a Family History of Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      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 experience high levels of
      perceived risk for developing BC. Elevated risk perceptions for BC have been associated with
      psychological distress, which, in turn, can interfere with screening adherence. In our
      completed CBCRI-funded study, we developed and standardized a group intervention designed to
      address the psychological issues associated with having a family history of BC. Results
      demonstrated that the intervention led to significant improvement in levels of anxiety and
      depression, improved BC risk factors/genetics knowledge and was associated with optimal
      screening behavior. The proposed study will rigorously test the group intervention in
      comparison to standard risk counselling in a sample of 150 women recruited from Familial BC
      clinics in Toronto. The interventions will be examined for their impact on a) psychological
      functioning, b) BC risk/genetic knowledge and c) screening behaviors.
    

Detailed description: 
      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.
    

Intervention name(s): Supportive-Expressive Group Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Breast cancer; Genetics; Psychotherapy; Group counselling; Randomized control trial; Risk counselling; Women's mental health; Familial breast cancer