Prostate CancerNCT00207636
Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening
A study testing Computer Assisted Decision making tool in people with Prostate Cancer, run by Centers for Disease Control and Prevention at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. Read more about this study
- Who is it for?
- Ages 45 to 65 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Computer Assisted Decision making tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 812 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Worksites employing at least 100 men in target age group (45-65 years old)
Who cannot join
- Worksites with high turnover
- Non-English speaking workers
- Temporary or contract workers
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.
Read the detailed description
Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.
In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men's ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.
- Conditions
- Prostate Cancer
- Being tested
- Computer Assisted Decision making tool
- Keywords
- Computer-Assisted Decision Making, Workplace, Screening
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Assisted Decision making toolBehavioural
The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Distribution of printed materials |
| Computer Assisted Decision making tool | Experimental | The intervention consisted of access to a computer tailored decision aid designed to promote informed decision making. Receives: Behavioral: Computer Assisted Decision making tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
Readiness to make a decision based on Stage of Decision-Making Scale (O'Connor A et al, 2008) with five responses ranging from "I haven't thought about it before" to "I have made a decision, and I am not likely to change my mind." Men were classified as having "decided" if they stated either that they had made a decision, but were willing to reconsider, or if they responded that they had made a decision but were unlikely to change their mind. Those "undecided" reported that they had not thought about the decision, or were uncertain.
Measured: Assessed at baseline and follow-up, up to 10 months
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.
Recognition of test based upon a standard single item and 14 validated questions assessed knowledge of prostate cancer prevalence, risk factors, screening modalities, diagnostic procedures, and treatment-related complications.
Measured: Assessed at baseline and follow-up, up to 10 months
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.
The confidence in ability to participate in decision making to the extent desired using the 11-item Decision Self-Efficacy Scale was assessed. Respondents were asked to reflect on their confidence level about various aspects of the decision-making process, with response options of "very confident" (score = 4) to "not at all confident" (score = 0). Scores were summed, divided by 11, and multiplied by 25, to arrive at a range of scores from 0 (no self-efficacy) to 100 (higher self-efficacy).
Measured: Assessed at baseline and follow-up, up to 10 months
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision
Items were developed to assess the personal importance or relative worth of the advantages and limitations of screening based on focus group themes and published literature. Some to the themes include: importance of information, accuracy of test, potential side effects of treatment.
Measured: Assessed at baseline and follow-up, up to 10 months
Secondary outcomes (2)
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles
Assessed through the Control Preferences Scale (Degner LF et al, 1997). Individuals were assessed who should make medical decisions. The active decision-making category included responses where men made the final decision on their own or after considering their doctor's opinions. The collaborative decision-making category included responses where men and their doctors shared the responsibility for the decision. The passive decision-making category included responses where the doctors made the final decision after considering a man's input or that the doctor made the final decision.
Measured: Assessed at baseline and follow-up, up to 10 months
Mean and Standard Error of a Scale to Measure Decisional Conflict
Measured through the Decisional Conflict Scale (O'Connor AM et al, 2003) by rating statements related to decision making and responding on a five-point scale ranging from "strongly agree' to "strongly disagree". Scales were standardized from 0 (no conflict) to 100 (extreme conflict).
Measured: Assessed at baseline and follow-up, up to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Jennifer D Allen, PN MPH ScD, Principal investigator, Dana-Farber Cancer Institute; Harvard School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00207636
- Sponsor's protocol ID
- CDC-NCCDPHP-2504
- Status last verified
- Dec 2024
- First submitted
- 15 Sep 2005
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Allen JD, Othus MK, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2172-86. doi: 10.1158/1055-9965.EPI-09-0410. Epub 2010 Aug 17.
PubMed 20716619
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventions in Non-medical Settings to Increase Informed Decision Making for Prostate Cancer Screening - Harvard - SIP 21-04
- ClinicalTrials.gov ID
- NCT00207636
- Acronym / sponsor ID
- CDC-NCCDPHP-2504
- Conditions
- Prostate Cancer
- Keywords
- Computer-Assisted Decision Making, Workplace, Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- Dec 2004
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and evaluate a computer-based decision aid (DA) for use by men considering prostate-specific antigen (PSA) screening for prostate cancer. Major medical organizations recommend that men discuss the risks and benefits of this test with their physician before making the decision. This educational, interactive DA will help them prepare for that discussion.
Detailed description
Prostate cancer (CaP) is a formidable public health problem in the US and in industrialized countries worldwide. Methods for primary prevention of CaP are unknown. As a result, early detection has become a mainstay of cancer control efforts. However, there is considerable controversy regarding the efficacy of screening in reducing disease-specific mortality. In light of this uncertainty, major medical organizations, including the National Cancer Institute, currently recommend that men discuss the pros and cons of CaP screening and make individualized screening decisions with their health care providers. However, because of constraints on time during medical encounters, it is not always feasible for providers to engage in in-depth discussions regarding the complexities of this issue. Therefore, interventions to promote informed decision-making (IDM) outside of clinical settings are needed.
In this study, we propose to: (1) develop an interactive computer-based decision aid (DA) to promote IDM for CaP screening; and (2) conduct a randomized controlled worksite trial to evaluate the impact the DA intervention on employed men's ability to make informed decisions regarding CaP. This work is designed to be responsive to recent calls for IDM interventions in community settings among diverse populations. If successful, our findings could validate the effectiveness of DAs to promote IDM for CaP and serve as a model for widespread dissemination, thus improving quality of care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Distribution of printed materials |
| Computer Assisted Decision making tool | Experimental | Behavioral: Computer Assisted Decision making toolThe intervention consisted of access to a computer tailored decision aid designed to promote informed decision making. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Worksites employing at least 100 men in target age group (45-65 years old)
Key exclusion criteria (3 listed)
- Worksites with high turnover
- Non-English speaking workers
- Temporary or contract workers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer Assisted Decision making toolThe intervention consisted of access to a computer tailored decision aid designed to promote informed decision making. | Behavioural | Computer Assisted Decision making tool |
Primary outcome
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided
Time frame: Assessed at baseline and follow-up, up to 10 months
Readiness to make a decision based on Stage of Decision-Making Scale (O'Connor A et al, 2008) with five responses ranging from "I haven't thought about it before" to "I have made a decision, and I am not likely to change my mind." Men were classified as having "decided" if they stated either that they had made a decision, but were willing to reconsider, or if they responded that they had made a decision but were unlikely to change their mind. Those "undecided" reported that they had not thought about the decision, or were uncertain.
Percentage of Correct Responses in Assessing Mens' Recognition of the Prostate-specific Antigen Test and Knowledge Related to Prostate-cancer Topics.
Time frame: Assessed at baseline and follow-up, up to 10 months
Recognition of test based upon a standard single item and 14 validated questions assessed knowledge of prostate cancer prevalence, risk factors, screening modalities, diagnostic procedures, and treatment-related complications.
Mean and Standard Error of a Scale Used to Assess Men's Confidence Level in Making Decisions Related to Prostate Cancer Screening.
Time frame: Assessed at baseline and follow-up, up to 10 months
The confidence in ability to participate in decision making to the extent desired using the 11-item Decision Self-Efficacy Scale was assessed. Respondents were asked to reflect on their confidence level about various aspects of the decision-making process, with response options of "very confident" (score = 4) to "not at all confident" (score = 0). Scores were summed, divided by 11, and multiplied by 25, to arrive at a range of scores from 0 (no self-efficacy) to 100 (higher self-efficacy).
Percentage of Consistency Between Screening Preference and Personal Values Relevant to the Screening Decision
Time frame: Assessed at baseline and follow-up, up to 10 months
Items were developed to assess the personal importance or relative worth of the advantages and limitations of screening based on focus group themes and published literature. Some to the themes include: importance of information, accuracy of test, potential side effects of treatment.
2 secondary outcomes
Percentage of Men Who Have Active Decision-making, Collaborative Decision-making, or Passive Decision-making Styles
Time frame: Assessed at baseline and follow-up, up to 10 months
Mean and Standard Error of a Scale to Measure Decisional Conflict
Time frame: Assessed at baseline and follow-up, up to 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20716619Allen JD, Othus MK, Hart A Jr, Tom L, Li Y, Berry D, Bowen D. A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial. Cancer Epidemiol Biomarkers Prev. 2010 Sep;19(9):2172-86. doi: 10.1158/1055-9965.EPI-09-0410. Epub 2010 Aug 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer D Allen, PN MPH ScD principal investigator
Dana-Farber Cancer Institute; Harvard School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Assisted Decision making tool in people with Prostate Cancer, run by Centers for Disease Control and Prevention at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients Who Were Ready to Make a Decision or Were Undecided (time frame: Assessed at baseline and follow-up, up to 10 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00207636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.