None listed
Conditions
Brief summary
The strongest risk factors for prostate cancer are age and having a family history of the disease. Men at increased risk for prostate cancer on the basis of family history are confronted with difficult decisions regarding the management of their cancer risk, particularly in view of the ongoing controversary surrounding the balance of uncertain benefits and harms of PSA testing. An online screening decision aid was developed to assist unaffected men with a family history of prostate cancer to make informed decisions about prostate cancer screening. The aim of this study is to compare in a randomised controlled trial the efficacy of general information about prostate cancer screening with that of an online screening decision aid, developed specifically for men with a family history of prostate cancer. The control information is comparable to the decision aid in identifying the general benefits and risks of prostate cancer screening. However, it does not include features commonly used in decision aids e.g., a personal worksheet and provision of details about the pros and cons of each option. The randomised trial will involve 120 unaffected men with a family history of prostate cancer who will complete three questionnaires at three time points: i) Questionnaire 1: before reading the online decision aid or general information (control) materials; ii) Questionnaire 2: immediately after reading the materials; and iii) Questionnaire 3: 12 months after reading the materials, to assess the longer term effect of the information. The sample will be randomised such that there will be approximately 60 participants in each group. The following hypotheses will be tested: Compared to men receiving the control materials, men who receive the decision aid will have:- (i) less decisional conflict and uncertainty about their risk management options (primary outcome variable); (ii) better knowledge of the genetics of prostate cancer and their screening options; (iii) more accurate perceptions of their risk of developing prostate cancer.
Interventions
The intervention is an online decision aid (DA) consisting of 15 screens. The DA contains information about: prostate cancer; prostate cancer prevention; familial prostate cancer; types of prostate cancer screening available; possible screening results; possible outcomes of a PSA test; diagnosis of prostate cancer through biopsy and ultrasound; prostate cancer treatment and side effects; an interactive personal worksheet regarding the pros and cons of prostate cancer screening, and two example w
The intervention is an online decision aid (DA) consisting of 15 screens. The DA contains information about: prostate cancer; prostate cancer prevention; familial prostate cancer; types of prostate cancer screening available; possible screening results; possible outcomes of a PSA test; diagnosis of prostate cancer through biopsy and ultrasound; prostate cancer treatment and side effects; an interactive personal worksheet regarding the pros and cons of prostate cancer screening, and two example worksheets. Men are also presented with tailored information about their chances of being diagnosed with, and dying from, prostate cancer over the next 10 years if they choose to have annual screening, compared to no screening. Contingent upon men's responses to three questions regarding their age and personal and family history of prostate cancer, men who are randomised to the DA condition are automatically directed to one of eight versions of the DA containing risk statistics appropriate for their age group (40-49 yrs; 50-59 yrs; 60-69 yrs or 70-79 yrs) and risk status (moderate- or high- risk). A man is classified at 'moderate risk' if he has: one first degree relative (FDR) or one second degree relative (SDR) diagnosed with prostate cancer, or; two SDR diagnosed with prostate cancer; or one FDR plus one SDR affected with prostate cancer. A man is classified at 'high risk' if he has two FDR with prostate cancer, or three or more FDR or SDR with prostate cancer. The eight versions of the DA are identical in content with the exception that the risk statistics in each version regarding the chances of being diagnosed with, or dying from, prostate cancer with or without annual screening over the next 10 years, are tailored to the age and family history data of the user. Hence, the eight versions of the DA contain tailored information as follows: DA Version 1: for men aged 40-49 years at moderate risk DA Version 2: for men aged 50-59 years at moderate risk DA Version 3: for men aged 60-69 years at moderate risk DA Version 4: for men aged 70-79 years at moderate risk DA Version 5: for men aged 40-49 years at high risk DA Version 6: for men aged 50-59 years at high risk DA Version 7: for men aged 60-69 years at high risk DA Version 8: for men aged 70-79 years at high risk
Sponsors
Dr Kaaren Watts
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
1. No previous diagnosis of prostate cancer; 2. Have at least one first degree or one second degree relative diagnosed with prostate cancer; 3. Aged 40 to 79 years 4. Able to complete online questionnaires written in English
Exclusion criteria
Previously diagnosed with prostate cancer Unable to complete questionnaires written in English Unable to give informed consent
Outcome results
None listed