TerminatedPhase 3ACTRN12607000316404

Genetic Risk Information Disclosure study.

A prospective, multicentre, open, parallel group, randomised controlled trial to evaluate the effectiveness of passive versus active disclosure of genetic information to those at risk of familial cancer.

Sponsor

The Cancer Council Victoria

Enrollment

40 participants

Start Date

Dec 11, 2007

Study Type

Interventional

Conditions

Genetic mutations predisposing to breast, ovarian or colorectal cancer and methods of disclosing that information to relatives.

Summary

This study looks at the disclosure of information indicating a genetic risk of cancer. Who is it for? You can join this study if you attend a Victorian Familial Cancer Centre and you are the first person in your family to have a genetic (mutation) test for breast, ovarian or colorectal cancer and your test is positive (that is, you have a gene that predisposes you to cancer). Trial details Participants will be randomly divided into two groups. Participants in one group (the treatment group) will be encouraged to tell their relatives about the result of their genetic test, and a Risk Notification Letter will also be sent to their relatives from the Familial Cancer Centre. This process is called ‘active disclosure’. Participants in the other group (the control group) will be encouraged to tell their relatives the result of their genetic test, but a letter will not be sent from the Familial Cancer Centre. This process is called ‘passive disclosure’. The number of relatives from both groups who contact the Familial Cancer Centre during the next year will be recorded. The number of relatives who have genetic tests and the acceptability of the process to participants and their relatives will also be measured. The aim of the study is to test whether active disclosure may be a more effective and acceptable way of providing information to people who may have a genetic predisposition to cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study explores how families share genetic test results that show a hereditary risk for breast, ovarian, or colorectal cancer. It is for adults aged 18 and older who are the first person in their family to be tested and received a positive result at a Victorian Familial Cancer Centre.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Individual who are the first in their family to undertake mutation detection for a pathogenic mutation in either breast, ovarian or colorectal cancer and test positive are designated the proband. Pro

Individual who are the first in their family to undertake mutation detection for a pathogenic mutation in either breast, ovarian or colorectal cancer and test positive are designated the proband. Probands are randomised to inform first and second degree relatives of their potential risk via either an active or passive method of disclosure. On the active disclosure arm, probands are encouraged to communicate directly with their relatives to inform them of their potential risk. In addition a Risk Notification Letter will be sent by the Familial Cancer Centre (FCC) to at risk relatives (ARR) informing them of the same. Probands randomised to the passive arm will be encouraged to inform their relatives of their potential risk but the FCC will not make contact with ARRs. Expected duration of recruitment and data capture phase of trial is 24 months.

Locations(1)

VIC, Australia

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ACTRN12607000316404