Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000850976
Ethics application status
Approved
Date submitted
9/08/2011
Date registered
10/08/2011
Date last updated
12/05/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial evaluating the efficacy of an online decision aid for unaffected men with a family history
of prostate cancer
Scientific title
A randomised controlled trial evaluating the efficacy of an online decision aid compared to general information about screening on decisional uncertainty among unaffected men with a family history of prostate cancer
Secondary ID [1] 262810 0
Nil
Universal Trial Number (UTN)
U1111-1123-5885
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
prostate cancer 270517 0
Condition category
Condition code
Cancer 270682 270682 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 269159 0
Early detection / Screening
Comparator / control treatment
The control/comparator condition consists of online educational materials about prostate cancer screening (11 screens). The control condition contains content identical to that in the eight versions of the DA, including 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; and prostate cancer treatment and side effects. However, in contrast to the DA , there is only ONE version of the control materials. This is because the control materials do NOT contain tailored information about the chances of being diagnosed with, or dying from prostate cancer, with our without annual screening over the next 10 years. In addition, the control materials do NOT include the following key components of the DA: (i) the interactive personal worksheet (regarding the pros and cons of PSA testing), (ii) two example worksheets completed by hypothetical men in a similar situation, and (iii) the section entitled ‘is it common to inherit an increased chance of developing prostate cancer?’. Hence, men who are randomised to the control condition, receive an identical version of these educational materials.
Control group
Active

Outcomes
Primary outcome [1] 269402 0
Decisional conflict regarding PSA testing.
Decisional conflict is assessed in an online questionnaire administered at baseline, prior to reading the information materials (Time 1), immediately after reading the materials (Time 2), and at 12 months follow-up (Time 3) using the validated low literacy version of the Decisional Conflict Scale (DCS) [1]. Ten items assess participants uncertainty regarding their current intention about having a PSA test in the next year with the following response options: 0=Yes, 2=Unsure and 4=No. The total score is calculated by summing the 10 items, dividing them by 10, and then multiplying by 25. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)[1].


[1] O'Connor, A., User Manual - Decisional Conflict Scale [document on the Internet]. 1993 [updated 2010; cited 25 July 2011], Ottawa Hospital Research Institute: Ottawa.
Timepoint [1] 269402 0
Time 1: baseline prior to reading the online materials
Time 2: immediately after reading the online materials
Time 3: 12 months after enrolment in the study
Secondary outcome [1] 287552 0
Knowledge about prostate cancer screening
Ten items were purposively developed for this study, including six concept items, and four numeric items adapted from a previous study [2] to assess (i) the efficacy of PSA testing; (ii) the relevance and impact of a family history of prostate cancer, and (iii) understanding of the chances of being diagnosed with or dying from prostate cancer if screened. Three response options are provided for items 1-6 (true, false, dont know); and a numerical estimate is required for items 7 to 10. A score of 1 is given for a correct answer and a score of zero for an incorrect or dont know response. A total knowledge score is calculated by summing the correct responses (range 0-10). Knowledge is assessed in an online questionnaire administered at baseline, prior to reading the information materials (Time 1), immediately after reading the materials (Time 2), and at 12 months follow-up (Time 3)

[2] Mathieu, E., et al., Informed Choice in Mammography Screening. Archives of Internal Medicine, 2007. 167(19): p. 2039-2046.
Timepoint [1] 287552 0
Time 1: baseline prior to reading the online materials
Time 2: immediately after reading the online materials
Time 3: 12 months after enrolment in the study
Secondary outcome [2] 287553 0
Accuracy of perceived risk of prostate cancer
This outcome is a new variable which classifies men as either accurate or inaccurate (an overestimator or an underestimator) regarding their perceived risk of developing prostate cancer. Accuracy is calculated based on men's self-reported perceived risk of developing prostate cancer, using a systematic strategy derived from a previous study [3]. Perceived risk is assessed in a single item which asks men to: rate your chances of getting prostate cancer on an 11-point scale where 0=no chance and 100=100% chance, meaning you will definitely get it. Perceived risk is assessed in an online survey administered at Time 1, Time 2, and Time 3.

The new variable of accuracy of perceived risk is calculated by taking the difference between each mans 'objective risk' of prostate cancer and his 'perceived risk'. Objective risk is calculated by multiplying each mans relative risk (RR) of prostate cancer, based on his self-reported family history data (i.e. a RR of 2.0 for men at moderate risk or 5.0 for men at high risk) by .22 (the average lifetime risk of prostate cancer of 1 in 9)[4]. Participants whose perceived risk falls either one response option below or above their objective risk (20% for men at moderate risk 50% for men at high risk) are categorised as accurate estimators; and those above and below them are categorised as inaccurate estimators [3].

[3] Meiser, B., et al., Risk perceptions and knowledge of breast cancer genetics in women at increased risk of developing hereditary breast cancer. Psychology and Health, 2001. 16(3): p. 297-311.

[4] Australian Institute of Health and Welfare (AIHW), Cancer in Australia: An overview, 2006. Catalogue No. CAN 32. 2007: Canberra.
Timepoint [2] 287553 0
Time 1: baseline prior to reading the online materials
Time 2: immediately after reading the online materials
Time 3: 12 months after enrolment in the study
Secondary outcome [3] 287554 0
Intention regarding PSA testing
This outcome is assessed in an online questionnaire administered at Time 1, Time 2 and Time 3. A single item asks participants: which of the following best describes your current intention about having a PSA test in the next year. The response options are 1=I do not intend to have PSA testing; 2=I intend to have PSA testing, and 3=I intend to think about the issue further before I make a decision.
Timepoint [3] 287554 0
Time 1: baseline prior to reading the online materials
Time 2: immediately after reading the online materials
Time 3: 12 months after enrolment in the study
Secondary outcome [4] 287555 0
Prostate cancer screening behaviour
This outcome is assessed in an online survey at two timepoints, at Time 1 prior to reading the online materials and at Time 3, at 12 months' follow-up.

Time 1: A single item is administered which asks men: Have you ever had a PSA test to screen for prostate cancer? Men respond on a four-point scale ranging from 1=No to 4=Yes, I have had more than one PSA test in the last 12 months.

Time 3: A single item is administered which asks men: Have you had a PSA test since reading the online information materials about prostate cancer screening (i.e., in the last 12 months)? Men are required to respond Yes or No. To assess possible over-screening, we also ask men who respond Yes to: Tick the box that best describes how many PSA tests you have had since reading the online information materials about prostate cancer screening, as follows:
Box 1: I have had one PSA test in the last 12 months OR
Box 2: I have had more than one PSA test in the last 12 months.
Timepoint [4] 287555 0
Time 1: baseline, prior to reading the online materials
Time 3: 12 months after enrolment in the study

Eligibility
Key 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
Minimum age
40 Years
Maximum age
79 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Previously diagnosed with prostate cancer
Unable to complete questionnaires written in English
Unable to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Men register to participate in the study by entering a current email address and a password at the study website (www.prostatescreening.org.au) and then provide informed consent. After account activation, men answer 3 questions about their age and personal and family history of prostate cancer to confirm that they fulfil the eligibility criteria for the study. Ineligible men are unable to proceed beyond this point. Eligible men are then randomised, via an automated blocked randomisation process, to read either the decision aid or the control materials. Allocation is concealed because after eligibility for the study is confirmed, which occurs automatically via the inbuilt computer program, central randomisation occurs via the random sequence generated automatically by the computer. Hence, allocation is concealed through the automated computer program, and neither the participants nor the study co-ordinator (Dr Kaaren Watts) are aware of which condition the men will be allocated to at that time.

The study has been advertised to men in the general public using multiple strategie including: (i) advertisements placed in the print media and in a radio broadcast; (ii) links to the study website placed on the Cancer Council NSW website and links placed in the electronic newsletters of the University of NSW and Rotary Australia; and (iii) a targeted mail out of a study package to patients attending a private urology clinic for past or present prostate cancer (in Westmead NSW). The study package contained a study information sheet and a letter of invitation which patients were asked to pass on to their unaffected male relatives.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An automated blocked randomisation procedure has been used to ensure approximately equal numbers of men are allocated to the decision aid (intervention) and to the control materials.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Men who are randomised to receive the decision aid (DA) are automatically directed to 1 of 8 versions of the DA appropriate to their age and risk status, based upon their responses to 3 questions about age and personal and family history of prostate cancer.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/05/2010
Actual
1/08/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,NSW,ACT,QLD,SA,WA,NT,TAS

Funding & Sponsors
Funding source category [1] 269633 0
Government body
Name [1] 269633 0
Cancer Council Australia Strategic Research Partnership Grant
Country [1] 269633 0
Australia
Primary sponsor type
Individual
Name
Dr Kaaren Watts
Address
Psychosocial Research Group
Prince of Wales Hospital
Dickinson 3
High Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 266663 0
Individual
Name [1] 266663 0
A/Professor Bettina Meiser
Address [1] 266663 0
Psychosocial Research Group
Prince of Wales Hospital
Dickinson 3
High Street
Randwick NSW 2031
Country [1] 266663 0
Australia
Other collaborator category [1] 252189 0
Individual
Name [1] 252189 0
Dr Claire Wakefield
Address [1] 252189 0
Centre for Children's Cancer and Blood Disorders
Sydney Children's Hospital
Randwick NSW 2031
Country [1] 252189 0
Australia
Other collaborator category [2] 252190 0
Individual
Name [2] 252190 0
Associate Professor Bettina Meiser
Address [2] 252190 0
Psychosocial Research Group
Prince of Wales Hospital
Dickinson 3
High Street
Randwick NSW 2031
Country [2] 252190 0
Australia
Other collaborator category [3] 252191 0
Individual
Name [3] 252191 0
Dr Manish Patel
Address [3] 252191 0
Department of Surgery
Westmead Hospital
Cnr Darcy and Hawkesbury Rds
Westmead NSW 2145
Country [3] 252191 0
Australia
Other collaborator category [4] 252192 0
Individual
Name [4] 252192 0
Professor Alex Barratt
Address [4] 252192 0
School of Public Health
University of Sydney
Sydney NSW 2006
Country [4] 252192 0
Australia
Other collaborator category [5] 252193 0
Individual
Name [5] 252193 0
A/Professor Graham Mann
Address [5] 252193 0
Westmead Institute for Cancer Research
University of Sydney at Westmead Millennium Institute
Westmead NSW 2145
Country [5] 252193 0
Australia
Other collaborator category [6] 252194 0
Individual
Name [6] 252194 0
Clinical Associate Professor Elizabeth Lobb
Address [6] 252194 0
Calvary Health Care Sydney
PO Box 261
Kogarah NSW 1485
Country [6] 252194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269577 0
Sydney West Area Health Service Human Research Ethics Committee (Westmead Campus)
Ethics committee address [1] 269577 0
Research Office
Clinical Sciences Building
Westmead Hospital
Cnr Darcy & Hawkesbury Roads
Westmead NSW 2145
Ethics committee country [1] 269577 0
Australia
Date submitted for ethics approval [1] 269577 0
15/04/2009
Approval date [1] 269577 0
01/06/2009
Ethics approval number [1] 269577 0
HREC2009/5/4.9 (2976)

Summary
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.
Trial website
www.prostatescreening.org.au
Trial related presentations / publications
Wakefield, C, Meiser B, Watts K, Barratt A, Patel M, Mann G, Lobb E, Howard K, Gaff G, Ramsay J. (2008, May). Development of a tailored, online decision aid on screening options for unaffected men with a family history of prostate cancer. European Journal of Human Genetics: May 2008. 16(Suppl. 2):458.

Wakefield CE, Meiser B, Watts K, Barratt A, Patel M, Mann G, Lobb E, Howard K, Gaff G, Ramsay J. Development of a tailored, online decision aid on screening options for unaffected men with a family history of prostate cancer. Psycho-Oncology, 17:S1-S348 (2008).
Watts KJ; Wakefield CE; Meiser B; Sansom-daly U; Barratt A; Patel MS; Lobb E; Gaff C; Howard K; Mann G, 2009, 'Two-stage development and pilot-testing of an online screening decision aid for men with a family history of prostate cancer', in Asia-Pacific Journal of Clinical Oncology, Blackwell Publishing Asia, Australia, pp. A260 - A260, presented at 36th Annual Meeting of the Clinical Oncological Society of Australia, Gold Coast, Queensland, 17 - 19 November 2009

Watts, KJ, Wakefield CE, Meiser B, Sansom-Daly U, Barratt A, Patel MI, Lobb EA, Gaff CL, Howard K, Mann GJ. An online screening decision aid for men with a family history of prostate cancer: Development and pilot-testing. European Journal of Human Genetics: June 1010; 18(Suppl 1); 388-389

Meiser B, Watts KJ, Wakefield CE, Sansom-Daly U, Barratt A, Patel MI, Lobb EA, Gaff CL, Howard K, Mann GJ. An online screening decision aid for men with a family history of prostate cancer: Development and pilot-testing. Oral presentation at kConFab 2010 Meeting, 17-20 August 2010, Kingscliffe, Qld Australia. [Presenter: Meiser]

Meiser B, Watts KJ, Wakefield CE, Sansom-Daly U, Barratt A, Patel MI, Lobb EA, Gaff CL, Howard K, Mann GJ. An online screening decision aid for men with a family history of prostate cancer: development and pilot-testing. 12th International Meeting on Psychosocial Aspects of Hereditary Cancer April, 2011. Amsterdam. (Poster Presentation, Meiser).

Peer-Reviewed Articles:
Wakefield CE, Watts KJ, Meiser B, Sansom-Daly U, Barratt A, Mann GJ, Lobb EA, Gaff CL, Howard K, Patel MI. Development and pilot testing of an online screening decision aid for men with a family history of prostate cancer. Patient Education and Counseling 83;64-72, 2011.

Watts KJ, Meiser B, Wakefield CE, Barratt AL, Howard K, Cheah BC, Mann GJ, Lobb EA, Gaff CL, Patel MI. Online Prostate Cancer Screening Decision Aid for At-Risk Men: A Randomized Trial. Health Psychol. 2013 Nov 25. [Epub ahead of print]
Public notes

Contacts
Principal investigator
Name 32998 0
A/Prof Bettina Meiser
Address 32998 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 32998 0
Australia
Phone 32998 0
+61293850025
Fax 32998 0
Email 32998 0
[email protected]
Contact person for public queries
Name 16245 0
A/Prof Bettina Meiser
Address 16245 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 16245 0
Australia
Phone 16245 0
+61293850025
Fax 16245 0
61293850033
Email 16245 0
[email protected]
Contact person for scientific queries
Name 7173 0
A/Prof Bettina Meiser
Address 7173 0
Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052
Country 7173 0
Australia
Phone 7173 0
+61293850025
Fax 7173 0
61293850033
Email 7173 0
[email protected]

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