ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

U1111-1123-5885

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

prostate cancer

Condition category

Condition code

Cancer

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Government body

Name [1]

Cancer Council Australia Strategic Research Partnership Grant

Address [1]

Level 1
120 Chalmers Street
Surry Hills NSW 2010

Country [1]

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]

Individual

Name [1]

A/Professor Bettina Meiser

Address [1]

Psychosocial Research Group
Prince of Wales Hospital
Dickinson 3
High Street
Randwick NSW 2031

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Dr Claire Wakefield

Address [1]

Centre for Children's Cancer and Blood Disorders
Sydney Children's Hospital
Randwick NSW 2031

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Associate Professor Bettina Meiser

Address [2]

Psychosocial Research Group
Prince of Wales Hospital
Dickinson 3
High Street
Randwick NSW 2031

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Manish Patel

Address [3]

Department of Surgery
Westmead Hospital
Cnr Darcy and Hawkesbury Rds
Westmead NSW 2145

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Professor Alex Barratt

Address [4]

School of Public Health
University of Sydney
Sydney NSW 2006

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

A/Professor Graham Mann

Address [5]

Westmead Institute for Cancer Research
University of Sydney at Westmead Millennium Institute
Westmead NSW 2145

Country [5]

Australia

Other collaborator category [6]

Individual

Name [6]

Clinical Associate Professor Elizabeth Lobb

Address [6]

Calvary Health Care Sydney
PO Box 261
Kogarah NSW 1485

Country [6]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney West Area Health Service Human Research Ethics Committee (Westmead Campus)

Ethics committee address [1]

Research Office
Clinical Sciences Building
Westmead Hospital
Cnr Darcy & Hawkesbury Roads
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/04/2009

Approval date [1]

01/06/2009

Ethics approval number [1]

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

A/Prof Bettina Meiser

Address

Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052

Country

Australia

Phone

+61293850025

Fax

b.meiser@unsw.edu.au

Contact person for public queries

Name

Bettina Meiser

Address

Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052

Country

Australia

Phone

+61293850025

Fax

61293850033

b.meiser@unsw.edu.au

Contact person for scientific queries

Name

Bettina Meiser

Address

Psychosocial Research Group (PRG), Prince of Wales Clinical School, Level 4, C25 Lowy Research Centre, University of New South Wales, Sydney NSW 2052

Country

Australia

Phone

+61293850025

Fax

61293850033

b.meiser@unsw.edu.au

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