Prostate CancerNCT03322891
Improving Health Literacy in African-American Prostate Cancer Patients
A study testing Educational Supplement and Standard Practice Education in people with Prostate Cancer, run by Emory University at 4 sites in United States.
Trial summary
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low… Read more about this study
- Who is it for?
- Ages 25 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Educational Supplement and Standard Practice Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jul 2016to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam
Who cannot join
- RN or MD degree
- History of head injury or dementia
- History of cognitive impairment
- Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Atlanta VA Medical Center
Atlanta, Georgia, 30033
Mohammad Hajiha, MD, 404-778-4898, mhajiha@emory.edu
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Viraj Master, MD, 404-778-4898, vmaster@emory.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Viraj Master, MD, 404-778-4898, vmaster@emory.edu
- Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Viraj Master, MD, 404-778-4898, vmaster@emory.edu
About this study
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Read the detailed description
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.
The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.
- Conditions
- Prostate Cancer
- Being tested
- Educational Supplement, Standard Practice Education
- Keywords
- Urology
- 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 SupplementOther
Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.
Standard Practice EducationOther
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
| Study group | Role | What they receive |
|---|---|---|
| Educational Supplement | Experimental | Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects. Receives: Other: Educational Supplement; Other: Standard Practice Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Decisional Conflict Scale Score
The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Measured: Baseline, Post-Intervention (Up to 6 Weeks)
Change in Comprehension of Treatment Options Score assessed by Interview
Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Measured: Baseline, Post-Intervention (Up to 6 Weeks)
Change in Comprehension of Side Effects Score assessed by Interview
Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Measured: Baseline, Post-Intervention (Up to 6 Weeks)
Secondary outcomes (2)
Rapid Estimate of Adult Literacy in Medicine (REALM) Score
The REALM is a screening instrument to assess an adult patient's ability to read common medical words and lay terms for body parts and illnesses. Scores are assessed on an education grade equivalent;
0-18 = 3rd Grade and Below Will not be able to read most low literacy materials; will need repeated oral instructions, materials composed primarily of illustrations, or audio or video tapes
19-44 = 4th to 6th Grade Will need low literacy materials; may not be able to read prescription labels
45-60 = 7th to 8th Grade Will struggle with most patient education materials
61-66 = High School Will be able to read most patient education materials
Measured: Baseline
Change in the Stage of Decision Making Scale Score
Stage of decision making refers to individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options. This tool is not scored. However, the categories can be used to determine co-variation in decisional conflict (tends to be higher in earlier stages) and success of interventions (success higher among those in active deliberation stage).
Measured: Baseline, Post-Intervention (Up to 6 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2017
- Study start21 Jul 2016
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Viraj Master, Emory University
- Investigators
- Kerry Kilbridge, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03322891
- Sponsor's protocol ID
- IRB00091879
- Status last verified
- Jan 2026
- First submitted
- 23 Oct 2017
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health Literacy in African-American Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT03322891
- Acronym / sponsor ID
- IRB00091879
- Conditions
- Prostate Cancer
- Keywords
- Urology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 26 Oct 2017 (actual)
- 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.
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Detailed description
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.
The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Educational Supplement | Experimental | Other: Educational Supplement, Other: Standard Practice EducationParticipants diagnosed with prostate cancer will receive education for treatment options and treatment side effects. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam
Key exclusion criteria (4 listed)
- RN or MD degree
- History of head injury or dementia
- History of cognitive impairment
- Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider
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 SupplementParticipants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes. | Other | Educational Supplement |
| Standard Practice EducationParticipants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician. | Other | Educational Supplement |
Primary outcome
Change in Decisional Conflict Scale Score
Time frame: Baseline, Post-Intervention (Up to 6 Weeks)
The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
Change in Comprehension of Treatment Options Score assessed by Interview
Time frame: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
Change in Comprehension of Side Effects Score assessed by Interview
Time frame: Baseline, Post-Intervention (Up to 6 Weeks)
Comprehension of side effects will be scored as dichotomous variables, correct or incorrect. The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
2 secondary outcomes
Rapid Estimate of Adult Literacy in Medicine (REALM) Score
Time frame: Baseline
Change in the Stage of Decision Making Scale Score
Time frame: Baseline, Post-Intervention (Up to 6 Weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
Kerry Kilbridge, MD principal investigator
Dana-Farber Cancer Institute
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Supplement and Standard Practice Education in people with Prostate Cancer, run by Emory University at 4 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viraj Master, MD (404-778-4898, vmaster@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Decisional Conflict Scale Score (time frame: Baseline, Post-Intervention (Up to 6 Weeks)). 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?
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 29 Jan 2026.