Prostate CancerPhase 3PCSEdNCT00623090
Internet-Based Education for Prostate Cancer Screening
A Phase 3 study testing educational internet site on prostate cancer screening and Educational print booklet in people with Prostate Cancer, run by Georgetown University at 2 sites in United States.
Trial summary
Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death. However, screening asymptomatic men remains controversial, as early diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in a randomized trial. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- educational internet site on prostate cancer screening and Educational print booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,893 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2007to Aug 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Active primary care patients at Georgetown University Medical Center, Washington Hospital Center, or Medstar Physician Partners (I,e, seen during the past two years)
- English-speaking
- 45-70 years of age; AND
- Ability to provide meaningful consent.
Who cannot join
- History of prostate cancer.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death. However, screening asymptomatic men remains controversial, as early diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in a randomized trial. The goal of the current study is to develop and assess widely accessible methods to assist men in making informed decisions about PCa screening. We will compare the efficacy of a new web-based, interactive decision support approach to our existing print-based PCa screening decision tool, among a diverse sample of male primary care patients. Abundant evidence documents the expanding role of the Internet in increasing access to and understanding of health information and the need for systematic evaluations of Internet-based interventions. A novel aspect of the proposed trial will be our focus on cognitive biases as a factor that has limited the success of previous information-based interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term consequences bias.
Read the detailed description
In Phase I (months 1-8) of this five-year project, we will develop an interactive, Internet-based, patient information and decision aid. In Phase II (months 9-60), we will evaluate the impact of this decision aid in a randomized controlled trial with male primary care patients aged 45-70 from three Washington, District of Columbia area health care settings (N = 1875). Trial arms include: 1) print-based information and decision aid (Print), 2) web-based information plus interactive decision aid (Web), and 3) usual care (UC). Subjects will complete outcome assessments at baseline, one- and 13-months post-baseline. The specific aims are to: 1. Evaluate the impact of the delivery method (Web vs. Print vs. Usual Care) on the key patient outcome variables of knowledge, decisional satisfaction, and the screening decision. 2. Identify factors that moderate the interventions' impact on the primary outcomes. 3. Identify the mechanisms by which the interventions impact knowledge and decisional satisfaction. In exploratory analyses, we will evaluate factors that are related to use of the web and print materials. This research has the potential to make several significant and innovative contributions: 1) the development and evaluation of a widely accessible method of educating a heterogeneous group of patients about a controversial topic, which can be adapted for other similarly contentious issues, 2) a determination of whether Web based materials are a feasible method of patient education for this age cohort, compared to print materials, 3) an understanding of cognitive factors that may hinder comprehension of a controversial medical decision, 4) a determination of who among the target population benefits the most from a web-based intervention, and 5) the information required to streamline and target future web-based educational interventions.
- Conditions
- Prostate Cancer
- Being tested
- educational internet site on prostate cancer screening, Educational print booklet, Usual care
- Keywords
- prostate cancer screening education, behavioral oncology, randomized trial
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational internet site on prostate cancer screeningBehavioural
Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.
Educational print bookletBehavioural
Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
Usual careBehavioural
Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
| Study group | Role | What they receive |
|---|---|---|
| 1 Website | Experimental | Participants receive the Login information for the Internet we developed on prostate cancer screening. Receives: Behavioral: educational internet site on prostate cancer screening |
| 2 Booklet | Active comparator | Participants receive the education booklet we developed on prostate cancer screening. Receives: Behavioral: Educational print booklet |
| 3 Usual Care | Placebo comparator | Usual care: participants receive no intervention. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening decision
Measured: one-year follow up
knowledge about prostate cancer screening
Measured: one-month and one-year post-intervention
decisional satisfaction
Measured: one-month and one-year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2008 (estimated)
- Study startOct 2007
- Primary completionMar 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,893 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgetown University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Kathryn L. Taylor, Ph.D., Georgetown University
- Investigators
- Kathryn L. Taylor, PhD, Principal investigator, Georgetown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623090
- Sponsor's protocol ID
- PC051100
- Other IDs
- R01CA119168-01
- Acronym
- PCSEd
- Status last verified
- Dec 2012
- First submitted
- 14 Feb 2008
- Last updated
- 13 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Dorfman CS, Williams RM, Kassan EC, Red SN, Dawson DL, Tuong W, Parker ER, Ohene-Frempong J, Davis KM, Krist AH, Woolf SH, Schwartz MD, Fishman MB, Cole C, Taylor KL. The development of a web- and a print-based decision aid for prostate cancer screening. BMC Med Inform Decis Mak. 2010 Mar 3;10:12. doi: 10.1186/1472-6947-10-12.
PubMed 20199680
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Education for Prostate Cancer Screening
- ClinicalTrials.gov ID
- NCT00623090
- Acronym / sponsor ID
- PCSEd / PC051100
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer screening education, behavioral oncology, randomized trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,893 participants (actual)
- Lead sponsor
- Georgetown UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, National Cancer Institute (NCI)
- Study start
- Oct 2007
- Primary completion
- Mar 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 25 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death. However, screening asymptomatic men remains controversial, as early diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in a randomized trial. The goal of the current study is to develop and assess widely accessible methods to assist men in making informed decisions about PCa screening. We will compare the efficacy of a new web-based, interactive decision support approach to our existing print-based PCa screening decision tool, among a diverse sample of male primary care patients. Abundant evidence documents the expanding role of the Internet in increasing access to and understanding of health information and the need for systematic evaluations of Internet-based interventions. A novel aspect of the proposed trial will be our focus on cognitive biases as a factor that has limited the success of previous information-based interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term consequences bias.
Detailed description
In Phase I (months 1-8) of this five-year project, we will develop an interactive, Internet-based, patient information and decision aid. In Phase II (months 9-60), we will evaluate the impact of this decision aid in a randomized controlled trial with male primary care patients aged 45-70 from three Washington, District of Columbia area health care settings (N = 1875). Trial arms include: 1) print-based information and decision aid (Print), 2) web-based information plus interactive decision aid (Web), and 3) usual care (UC). Subjects will complete outcome assessments at baseline, one- and 13-months post-baseline. The specific aims are to: 1. Evaluate the impact of the delivery method (Web vs. Print vs. Usual Care) on the key patient outcome variables of knowledge, decisional satisfaction, and the screening decision. 2. Identify factors that moderate the interventions' impact on the primary outcomes. 3. Identify the mechanisms by which the interventions impact knowledge and decisional satisfaction. In exploratory analyses, we will evaluate factors that are related to use of the web and print materials. This research has the potential to make several significant and innovative contributions: 1) the development and evaluation of a widely accessible method of educating a heterogeneous group of patients about a controversial topic, which can be adapted for other similarly contentious issues, 2) a determination of whether Web based materials are a feasible method of patient education for this age cohort, compared to print materials, 3) an understanding of cognitive factors that may hinder comprehension of a controversial medical decision, 4) a determination of who among the target population benefits the most from a web-based intervention, and 5) the information required to streamline and target future web-based educational interventions.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Website | Experimental | Behavioral: educational internet site on prostate cancer screeningParticipants receive the Login information for the Internet we developed on prostate cancer screening. |
| 2 Booklet | Active comparator | Behavioral: Educational print bookletParticipants receive the education booklet we developed on prostate cancer screening. |
| 3 Usual Care | Placebo comparator | Behavioral: Usual careUsual care: participants receive no intervention. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Active primary care patients at Georgetown University Medical Center, Washington Hospital Center, or Medstar Physician Partners (I,e, seen during the past two years)
- English-speaking
- 45-70 years of age; AND
- Ability to provide meaningful consent.
Key exclusion criteria (1 listed)
- History of prostate cancer.
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 |
|---|---|---|
| educational internet site on prostate cancer screeningHealthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening. | Behavioural | 1 Website |
| Educational print bookletHealthy men between 45-70 receive a copy of our educational print booklet in the mail. | Behavioural | 2 Booklet |
| Usual careHealthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms. | Behavioural | 3 Usual Care |
Primary outcome
screening decision
Time frame: one-year follow up
knowledge about prostate cancer screening
Time frame: one-month and one-year post-intervention
decisional satisfaction
Time frame: one-month and one-year post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2012.
- Derived from this study: PubMed 20199680Dorfman CS, Williams RM, Kassan EC, Red SN, Dawson DL, Tuong W, Parker ER, Ohene-Frempong J, Davis KM, Krist AH, Woolf SH, Schwartz MD, Fishman MB, Cole C, Taylor KL. The development of a web- and a print-based decision aid for prostate cancer screening. BMC Med Inform Decis Mak. 2010 Mar 3;10:12. doi: 10.1186/1472-6947-10-12.
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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.
Kathryn L. Taylor, PhD principal investigator
Georgetown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing educational internet site on prostate cancer screening and Educational print booklet in people with Prostate Cancer, run by Georgetown University at 2 sites 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 4 inclusion and 1 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 13 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
screening decision (time frame: one-year follow up). The study lists 3 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 NCT00623090, 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 13 Dec 2012; AzTrials last refreshed its copy on 30 Oct 2026.