Psychosocial Aspects of Genomic Testing for Breast Cancer Risk

Not Applicable

Active, not recruiting

• Conditions: breast cancer; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12617000594325
• Lead Sponsor: Prof. Bettina Meiser, UNSW Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-27
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 217

Inclusion Criteria

Women enrolled in the ‘Variants in Practice’ study (ViP) provide a unique cohort in which to systematically ascertain the important psychosocial and clinical implications of genomic testing. The ViP study (HREC/11/PMCC/43) is enrolling a cohort of over 4,000 Victorian women and men who have a high-risk family history of breast cancer, that includes index cases with a personal history of breast cancer and their affected and unaffected relatives

Women aged 18 years and over who are current participants of the ViP study. Additional criteria includes women where a known breast cancer predisposition gene has been excluded as the cause of their personal and/or familial breast cancer risk, and who are sufficiently proficient in English to provide informed consent and complete questionnaires.

Both index cases with a personal history of breast cancer, and their family members (affected and unaffected) will be invited to participate in this psychosocial study. This study will include women with a low (N=200) and high (N=200) polygenic risk score. Each group will then stratified by disease status, such that about 100 affected and 100 unaffected women are included in each study group.

Exclusion Criteria

- Women where a known breast cancer predisposition gene mutation (e.g. BRCA1/2) has been identified as the cause of their personal and/or familial breast cancer
- male participants of the ViP study. Men will be excluded as they constitute a very small proportion of ViP participants (<10%) and therefore as the small sample size will preclude a meaningful statistical comparison with the majority female cohort.
- Women who receive an intermediate polygenic risk score will also be ineligible, because intermediate results do not change a woman’s risk status and hence risk management advice in a clinically meaningful way.
- The funding parameters for this project means that it is not feasible to develop the study documentation and the assessment tools in multiple languages. Hence, women must be able to complete English language self-administered questionnaires to be eligible to participate in the study.
- Patients with obvious intellectual or mental impairment that may interfere with the patient's ability to understand the requirements of the study will also be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified