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

NCT00150917 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2008-06-17

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

BEHAVIORAL

Supportive-Expressive Group Therapy

Sponsors & Collaborators

  • Canadian Breast Cancer Research Alliance

    collaborator OTHER

  • Canadian Cancer Trials Group

    collaborator NETWORK

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Mary Jane Esplen, PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2006-12-31
Completion
2007-01-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00150917 on ClinicalTrials.gov