RecruitingACTRN12605000573651

The development and evaluation of two decision aids for individuals considering genetic testing for hereditary cancer.

The impact of two decision aids for individuals considering genetic testing for hereditary breast/ovarian cancer or hereditary non-polyposis colorectal cancer (HNPCC) on psychological and decision-related outcomes.

Sponsor

Dr. Bettina Meiser

Enrollment

140 participants

Start Date

Jan 3, 2005

Study Type

Interventional

Conditions

Hereditary breast/ovarian cancer Hereditary non-polyposis colorectal cancer (HNPCC).

Summary

Background: The demand for genetic counselling and genetic testing for individuals with a family history of cancer is considerable and increasing. Current best practice in genetic counselling may not allow a full deliberation of the consequences of decisions about genetic testing for cancer susceptibility. Literature on risk perception in high-risk breast cancer families reveals persistent over-estimation of risk, even after counselling. In this study, two decision aids were designed to assist people deciding about genetic testing for cancer susceptibility. Methods: Stage 1. Two decision aids for individuals considering genetic testing for breast/ovarian cancer and hereditary non-polyposis colorectal cancer (HNPCC) susceptibility were developed and pilot tested with 25 women considering genetic testing for breast/ovarian cancer risk, and 18 individuals considering genetic testing for HNPCC risk. The aids were developed by a team of experts guided by expectancy-value decision theories and the literature on risk communication and the psychological impact of genetic testing. Stage 2: Involves two concurrent randomised controlled trials of the decision aids, each with 120 patients, assessed by questionnaire at two time points after genetic counselling. Results: Stage 1. Two 40 page two-colour decision aids were developed using varying formats of words, numbers, graphs, pie-charts and illustrations. Pilot testing results were positive, with all patients saying that they would recommend the decision aid to others facing the same situation, 93% reporting that the decision aid would have been relevant when they were making their decision about genetic testing and 84% of patients rating the amount of information contained as 'about right'. The decision aids were modified according to the results of the pilot testing. Stage 2 of the study is on-going. Preliminary results show that the decision aid may improve knowledge about genetic testing and may assist individuals to more accurately estimate their risk of developing cancer.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing decision aids — special booklets or tools — to help people decide whether or not to have genetic testing for hereditary cancer. The decision aids are for two types of hereditary cancer: hereditary breast and ovarian cancer, and hereditary non-polyposis colorectal cancer (HNPCC, also called Lynch syndrome). Deciding about genetic testing can be very difficult and emotional. These tools aim to help people understand their risks and make a decision that is right for them. You may be eligible if: - You are 18 years or older - You have a family history that suggests a hereditary risk of breast/ovarian cancer or HNPCC (Lynch syndrome) - You are eligible for genetic testing (either you have had cancer yourself, or you have a living relative with cancer who could be tested) - You can give informed consent and read English well - Men from HNPCC families are also welcome to participate You may NOT be eligible if: - You are a man from a hereditary breast cancer family (due to small numbers and different needs) Talk to your doctor about whether this trial might be right for you.

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

The study aims to compare the efficacy of an educational pamphlet currently used in the clinical setting to that of the decision aids using two randomised controlled trials. The decision aids will be

The study aims to compare the efficacy of an educational pamphlet currently used in the clinical setting to that of the decision aids using two randomised controlled trials. The decision aids will be tested with two different samples: 120 individuals at high risk for HNPCC and 120 members of high-risk breast cancer families who approach one of six familial cancer clinics who have agreed to participate in this study (the familial cancer clinics in NSW: at Prince of Wales, Westmead, St Vincents Hospitals and Hunter Genetics, Newcastle, and in Victoria: at Royal Melbourne Hospital, and the Peter McCallum Cancer Institute). Participants will complete a questionnaire after they have read the decision aid or pamphlet, followed by a second questionnaire after 6 months.

Locations(1)

Australia

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ACTRN12605000573651