None listed
Conditions
Brief 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.
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 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 Ho
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.
Sponsors
Dr. Bettina Meiser
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be eligible to participate in the study, patients must meet all the following criteria: (i) be at potentially high risk of breast/ovarian cancer (family history consistent with hereditary breast/ovarian cancer syndrome [National Breast Cancer Centre Category 3]) or HNPCC (family history consistent with HNPCC according to the revised Amsterdam criteria); (ii) be eligible for genetic testing, that is either be affected with cancer or, if unaffected, have a living, affected relative for whom mutation search would be appropriate; (iii) be able to give informed consent; (iv) be able to read English proficiently. Men from HNPCC families will be included because the larger number of them (compared to breast/ovarian cancer families) will enable meaningful statistical analysis of their responses.
Exclusion criteria
Men from breast cancer families will not be invited to participate because of the low number of men attending familial cancer clinics and because of the substantial differences in the needs of men attending these clinics compared to women.
Outcome results
None listed