RCT of a Group Intervention for Women With a Family History of Breast Cancer

June 12, 2008 updated by: University Health Network, Toronto

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

Study Overview

Status

Completed

Conditions

Breast Neoplasms

Intervention / Treatment

Behavioral: Supportive-Expressive Group Therapy

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.

Study Type

Interventional

Enrollment (Actual)

150

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - Toronto, Ontario, Canada, M5G 2C4
    - University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Psychosocial functioning (using standardized instruments) Time Frame: 1 year	1 year
Breast Cancer risk/genetic knowledge Time Frame: 1 year	1 year
Screening behaviors Time Frame: 1 year	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Post Traumatic Growth Time Frame: 1 year	1 year
Cost effectiveness Time Frame: 1 year	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Canadian Cancer Trials Group

Canadian Breast Cancer Research Alliance

Investigators

Principal Investigator: Mary Jane Esplen, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2001

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria