Prostate Cancer Screening DecisionPhase 2/3NCT01415375
Prostate Cancer Education in African American Men
A Phase 2/3 study testing Prostate Cancer Screening Education and Fruit and Vegetable Intake Education in people with Prostate Cancer Screening Decision, run by Temple University at 1 site in United States.
Trial summary
This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men. 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 Screening Decision
- What is being tested?
- Prostate Cancer Screening Education and Fruit and Vegetable Intake Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 490 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2009
- Phase
- Phase 2/3
- 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
- 45 to 70 year old
- African descent
- accessible by telephone
- have primary care physician
Who cannot join
- Prostate cancer test in 12 months prior to enrollment
- History of prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.
Read the detailed description
African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).
- Conditions
- Prostate Cancer Screening Decision
- Being tested
- Prostate Cancer Screening Education, Fruit and Vegetable Intake Education
- Keywords
- prostate-specific antigen (146-154), prostate-specific antigen (154-163)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate Cancer Screening EducationBehavioural
tailored telephone education on prostate cancer testing
Fruit and Vegetable Intake EducationBehavioural
tailored telephone education about fruit and vegetable consumption
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer Screening Education | Experimental | Men in the experimental intervention group received an educational pamphlet on prostate cancer testing as well as tailored telephone education in which the interventionist provided information, answered questions, and conducted a values clarification exercise with the participant. Receives: Behavioral: Prostate Cancer Screening Education |
| Fruit and Vegetable Intake Education | Other | Men in the attention control group received an educational pamphlet on daily recommended servings of fruits and vegetables as well as tailored telephone education in which the interventionist provided information, answered participant's questions, and discussed any barriers to eating fruits and vegetables. Receives: Behavioral: Fruit and Vegetable Intake Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
congruence between prostate cancer testing intention and behavior
Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0).
Measured: 1 and 2 years post randomization
Knowledge about prostate cancer and prostate cancer tests
12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure.
Measured: baseline and 8 months post randomization
Decisional conflict
Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations.
Measured: 8 months post randomization
Verified doctor visit to discuss prostate cancer testing
Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records
Measured: 2 years post randomization
Secondary outcomes (1)
State anxiety
Used a 7 item subscale of the Hospital Anxiety and Depression Scale.
Measured: baseline and 8 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2011 (estimated)
- Study startSep 2004
- Primary completionJul 2007
- Study completionJul 2009
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 Cancer Screening DecisionStudies 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 2/3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 490 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Lepore, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415375
- Sponsor's protocol ID
- R01CA104223
- Status last verified
- Apr 2015
- First submitted
- 10 Aug 2011
- Last updated
- 17 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lepore SJ, Wolf RL, Basch CE, Godfrey M, McGinty E, Shmukler C, Ullman R, Thomas N, Weinrich S. Informed decision making about prostate cancer testing in predominantly immigrant black men: a randomized controlled trial. Ann Behav Med. 2012 Dec;44(3):320-30. doi: 10.1007/s12160-012-9392-3.
PubMed 22825933
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Education in African American Men
- ClinicalTrials.gov ID
- NCT01415375
- Acronym / sponsor ID
- R01CA104223
- Conditions
- Prostate Cancer Screening Decision
- Keywords
- prostate-specific antigen (146-154), prostate-specific antigen (154-163)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 11 Aug 2011 (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 study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.
Detailed description
African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer Screening Education | Experimental | Behavioral: Prostate Cancer Screening EducationMen in the experimental intervention group received an educational pamphlet on prostate cancer testing as well as tailored telephone education in which the interventionist provided information, answered questions, and conducted a values clarification exercise with the participant. |
| Fruit and Vegetable Intake Education | Other | Behavioral: Fruit and Vegetable Intake EducationMen in the attention control group received an educational pamphlet on daily recommended servings of fruits and vegetables as well as tailored telephone education in which the interventionist provided information, answered participant's questions, and discussed any barriers to eating fruits and vegetables. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45 to 70 year old
- African descent
- accessible by telephone
- have primary care physician
Key exclusion criteria (2 listed)
- Prostate cancer test in 12 months prior to enrollment
- 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 |
|---|---|---|
| Prostate Cancer Screening Educationtailored telephone education on prostate cancer testing | Behavioural | Prostate Cancer Screening Education |
| Fruit and Vegetable Intake Educationtailored telephone education about fruit and vegetable consumption | Behavioural | Fruit and Vegetable Intake Education |
Primary outcome
congruence between prostate cancer testing intention and behavior
Time frame: 1 and 2 years post randomization
Congruence between men's stated intentions to get tested and their actual testing behavior, validated by medical claims at 1 and 2 year follow-up. Intention-behavior agreement was coded as congruent (1), whereas disagreement was coded as incongruent (0).
Knowledge about prostate cancer and prostate cancer tests
Time frame: baseline and 8 months post randomization
12 item knowledge index with questions on testing, risk factors and epidemiology, and treatment effectiveness and side effects. Percent correct was used as the outcome measure.
Decisional conflict
Time frame: 8 months post randomization
Used a modified version of the 16 item Decisional Conflict Scale with the 3 level response category suggested for low literacy populations.
Verified doctor visit to discuss prostate cancer testing
Time frame: 2 years post randomization
Visit with physician to talk about prostate cancer testing, with visit verified through medical claims records
1 secondary outcome
State anxiety
Time frame: baseline and 8 months post-randomization
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 17 Apr 2015.
- Background: PubMed 22825933Lepore SJ, Wolf RL, Basch CE, Godfrey M, McGinty E, Shmukler C, Ullman R, Thomas N, Weinrich S. Informed decision making about prostate cancer testing in predominantly immigrant black men: a randomized controlled trial. Ann Behav Med. 2012 Dec;44(3):320-30. doi: 10.1007/s12160-012-9392-3.
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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.
Stephen Lepore, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Prostate Cancer Screening Education and Fruit and Vegetable Intake Education in people with Prostate Cancer Screening Decision, run by Temple University 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 4 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: finished, as of the sponsor's last update on 17 Apr 2015. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
congruence between prostate cancer testing intention and behavior (time frame: 1 and 2 years post randomization). 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 NCT01415375, 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 17 Apr 2015.