Prostate CarcinomaNCT02419846
Informed Decision Making Intervention in Screening for Prostate Cancer of Predominantly African American Participants in a Community Outreach Program
A study testing Educational Intervention, digital rectal examination and Pre-test administration in people with Prostate Carcinoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Educational Intervention, digital rectal examination and Pre-test administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 319 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2015to Jul 2022
- Phase
- Interventional
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
- Educational component: men over the age of 18
- Screening component: men over age 40
Who cannot join
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.
Read the detailed description
PRIMARY OBJECTIVES:
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
- Conditions
- Prostate Carcinoma
- Being tested
- Educational Intervention, digital rectal examination, Pre-test administration, Survey Administration, Prostate-specific antigen measurement
- Keywords
- Informed Decision Making, Prostate, Cancer
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called PowerPoint Presentation, Intervention, Educational
Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
digital rectal examinationProcedure or surgery
Also called DRE
Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening
Pre-test administrationOther
Also called questionnaire administration
15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
Survey AdministrationOther
Also called Program Evaluation
Survey will be administered at the end of the program for participants to assess their experience
Prostate-specific antigen measurementOther
Also called PSA levels
PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
Post test administrationOther
Also called questionnaire administration
Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
| Study group | Role | What they receive |
|---|---|---|
| Men over 40: Screening with intervention | Experimental | Participants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam. Receives: Other: Educational Intervention; Procedure: digital rectal examination; Other: Pre-test administration; Other: Survey Administration; Other: Prostate-specific antigen measurement; Other: Post test administration |
| Men 18-39: Educational intervention | Experimental | Participants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Receives: Other: Educational Intervention; Other: Pre-test administration; Other: Survey Administration; Other: Post test administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.
Measured: Up to 1 year
Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions
Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.
Measured: Up to 1 year
Secondary outcomes (10)
Proportion of participants who choose to enter the clinical trial
Measured: Up to 1 year
Proportion of participants who choose screening after educational intervention
Measured: Up to 1 year
10-year expected mortality based on USCF 10-year Mortality Index for all participants
Measured: Up to 1 year
Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
Measured: Up to 1 year
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
Measured: Up to 1 year
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
Measured: Up to 1 year
Proportion of participants with family history of prostate cancer
Measured: Up to 1 year
Proportion of participants referred to a primary care physician who did not previously have a primary care physician
Measured: Up to 1 year
Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
Measured: Up to 1 year
Proportion of participants who expressed satisfied with this proposed informed consent and education model
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study start1 Jun 2015
- Primary completionOct 2021
- Study completionJul 2022
Why it stopped: Unable to recruit due to COVID limitations / Funding Unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 319 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Samir Abraksia, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419846
- Sponsor's protocol ID
- CASE3815
- Status last verified
- Jul 2022
- First submitted
- 14 Apr 2015
- Last updated
- 25 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Proposed Prostate Cancer Outreach Program in a Predominantly African American Community That Promotes Informed Decision-making for Prostate Cancer Screening and Utilizes Community Navigation
- ClinicalTrials.gov ID
- NCT02419846
- Acronym / sponsor ID
- CASE3815
- Conditions
- Prostate Carcinoma
- Keywords
- Informed Decision Making, Prostate, Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit due to COVID limitations / Funding Unavailable
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 17 Apr 2015 (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.
This clinical trial studies an informed decision making intervention of screening for prostate cancer in predominantly African American participants. It also evaluates participants' knowledge about prostate cancer screening and to improve understanding. Using decision aids such as culturally sensitive written material, verbal information, and videos to educate patients about screening may increase patient participation and knowledge. This may increase confidence in participants' decisions. Raising awareness about prostate cancer in the communities may increase the participants' willingness to be screened for prostate cancer once they have learned about it.
Detailed description
PRIMARY OBJECTIVES:
(A) To assess the effectiveness of a proposed educational model for informed decision about Prostate Cancer in high risk men over age 40 which compares informed decision making and shared decision making (B) to improve knowledge about prostate cancer in men over age 18
OUTLINE:
Participants complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Some participants then undergo a screening exam comprising a prostate specific antigen level and digital rectal exam.
After completion of study, participants are followed up periodically.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Men over 40: Screening with intervention | Experimental | Other: Educational Intervention, Procedure: digital rectal examination, Other: Pre-test administration, Other: Survey Administration, Other: Prostate-specific antigen measurement, Other: Post test administrationParticipants over the age of 40 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. Participants may undergo a screening exam comprising a prostate specific antigen level and digital rectal exam. |
| Men 18-39: Educational intervention | Experimental | Other: Educational Intervention, Other: Pre-test administration, Other: Survey Administration, Other: Post test administrationParticipants between 18 and 39 complete an educational intervention comprising a 10-20 minute PowerPoint presentation given by an experienced healthcare professional that discusses prostate cancer facts, screening guidelines, risks, benefits, and consequences. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men over the age of 18 will be asked to participate in the educational component of the program; men over the age of 40 will be offered the screening component after the educational portion of the event; participants over age of 40 will have the opportunity to make an informed decision in regards to prostate cancer screening based on this information and the educational material; American Cancer Society (ACS) guidelines recommend having a discussion about screening in men who have an expected mortality of greater than 10 years; data on comorbidities and 10-year mortalities will be collected on every participant using the University of California at San Francisco (UCSF) mortality index
- Educational component: men over the age of 18
- Screening component: men over age 40
Key exclusion criteria (2 listed)
- Known personal history of prostate cancer
- Active malignancy, metastatic disease, or anyone undergoing treatment for malignancy
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 InterventionAlso: PowerPoint Presentation, Intervention, EducationalAttend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences | Other | Men 18-39: Educational intervention, Men over 40: Screening with intervention |
| digital rectal examinationAlso: DREUndergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening | Procedure or surgery | Men over 40: Screening with intervention |
| Pre-test administrationAlso: questionnaire administration15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers | Other | Men 18-39: Educational intervention, Men over 40: Screening with intervention |
| Survey AdministrationAlso: Program EvaluationSurvey will be administered at the end of the program for participants to assess their experience | Other | Men 18-39: Educational intervention, Men over 40: Screening with intervention |
| Prostate-specific antigen measurementAlso: PSA levelsPSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines | Other | Men over 40: Screening with intervention |
| Post test administrationAlso: questionnaire administrationPost test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding | Other | Men 18-39: Educational intervention, Men over 40: Screening with intervention |
Primary outcome
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening
Time frame: Up to 1 year
Improved understanding will be defined as an increase in the number of correct answers seen on the post Prostate Screening Education Questionnaire. The underlying likelihood of a positive response, or improved understanding of prostate cancer screening, can be estimated using a 95% confidence interval that has a maximum half-width of 6%.
Proportion of participants over age 40 who find this education and screening model helpful in making an informed decision about prostate cancer screening as measured by the satisfaction survey questions
Time frame: Up to 1 year
Helpfulness of the program will be measured on a 5-point Likert scale where the two uppermost categories are considered a positive response.
10 secondary outcomes
Proportion of participants who choose to enter the clinical trial
Time frame: Up to 1 year
Proportion of participants who choose screening after educational intervention
Time frame: Up to 1 year
10-year expected mortality based on USCF 10-year Mortality Index for all participants
Time frame: Up to 1 year
Proportion of participants with a high 10-year mortality based on UCSF index who choose to be screened for prostate cancer after educational intervention
Time frame: Up to 1 year
Proportion of abnormal results found with screening and referred to follow-up assessed as per National Comprehensive Cancer Network guidelines
Time frame: Up to 1 year
Proportion of participants diagnosed with malignancy based on follow up biopsies and work-up during the course of the study
Time frame: Up to 1 year
Proportion of participants with family history of prostate cancer
Time frame: Up to 1 year
Proportion of participants referred to a primary care physician who did not previously have a primary care physician
Time frame: Up to 1 year
Proportion of participants who asked the physician to make a decision for them in spite of educational intervention
Time frame: Up to 1 year
Proportion of participants who expressed satisfied with this proposed informed consent and education model
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Unable to recruit due to COVID limitations / Funding Unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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.
Samir Abraksia, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, digital rectal examination and Pre-test administration in people with Prostate Carcinoma, run by Case Comprehensive Cancer Center 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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 25 Jul 2022. 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?
The study was stopped early (reason given: Unable to recruit due to COVID limitations / Funding Unavailable). Results are not available in the source record.
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?
Proportion of participants over age 18 that demonstrate improved knowledge about prostate cancer screening (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022; AzTrials last refreshed its copy on 31 Oct 2026.