Localized Prostate CarcinomaNCT06674863
Addressing Health Literacy With a Tailored Survivorship Care Plan
A study testing Educational Intervention, Interview and Questionnaire Administration in people with Localized Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Emory University at 3 sites in United States.
Trial summary
This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- What is being tested?
- Educational Intervention, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Nov 2025to 31 Dec 2030
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black and African American men who are disease-free after completing primary surgery and/or radiation treatment for localized or oligometastatic prostate cancer between 1 to 4 years prior to enrollment. (Race/ethnicity per medical records and self report)
- Patients who are still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included
Who cannot join
- Dementia or cognitive impairment per provider clinical assessment
- Unable to give informed consent in the judgement of the patient's oncology provider
- Recurrent prostate cancer after primary treatment
- Less than 18 years of age at the time of informed consent
- Diagnosis of active second malignancy requiring treatment
- Individuals who are not able to clearly understand English since the outcome measures require understanding of English
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Grady Memorial Hospital
Atlanta, Georgia, 30303
Sierra Williams, 404-778-4729, sierra.williams@emory.edu
Viraj Master, MD, PhD, FACS
- Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322
Sierra Williams, 404-778-4898, sierra.williams@emory.edu
Viraj Master, MD, PhD, FACS
- Recruiting
Atlanta VA Medical Center
Atlanta, Georgia, 30329
Sierra Williams, 404-778-4729, sierra.williams@emory.edu
Mohammad Hajiha, MD
About this study
Official title: Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- Compare outcomes after patients receive usual care from their providers with a standard SCP and after patients receive tailoring of the SCP with the low literacy educational supplement.
II. To quantify the potential benefit of tailoring the care plan and the educational supplement.
III. Compare providers' assessment of patients':
IIIa. Health literacy; IIIb. Comprehension of survivorship care recommendations; IIIc. Understanding of long term and late effects from treatment; IIId. To measures obtained from patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes.
GROUP II (CONTROL): Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.
- Conditions
- Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Being tested
- Educational Intervention, Interview, Questionnaire Administration, Supportive Care
- 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 InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive a low literacy educational supplement
InterviewOther
Undergo a structured interview
Questionnaire AdministrationOther
Ancillary studies
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive standard SCP
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Receive a tailored SCP
| Study group | Role | What they receive |
|---|---|---|
| Group I (standard SCP, tailored SCP) | Experimental | Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes. Receives: Other: Educational Intervention; Other: Interview; Other: Questionnaire Administration; Other: Supportive Care |
| Group II (standard SCP) | Active comparator | Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes. Receives: Other: Interview; Other: Questionnaire Administration; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of survivorship care recommendations and prostate specific antigen surveillance
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard survivorship care plan (SCP) compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P < 0.05.
Measured: At baseline and up to 3 month phone call
Comprehension of treatment side effects and late effects
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard SCP compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P < 0.05.
Measured: At baseline and up to 3 month phone call
Secondary outcomes (5)
Access to survivorship care for late and long-term side effects
Will be assessed using the Patients Access Score (PAS). Descriptive statistics will be used to characterize patient access to survivorship care. The difference in mean PAS will be compared between the two arms using a 2 sample t-test. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Linear regression models will be used to identify predictors of access to survivorship care. Parsimonious models will be favored due to the relatively small sample size.
Measured: At baseline and up to 3 month phone call
Decision regret
Descriptive statistics will be used to characterize decision regret. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.
Measured: At baseline and up to 3 month phone call
Change in decisional conflict
The two-sample t-test will be used to evaluate the change in the average decisional conflict score between patients in the control arm (standard SCP) and patients in the intervention arm (standard SCP + tailoring + educational supplement).
Measured: At baseline and up to 3 month phone call
Preparedness for survivorship
Descriptive statistics will be used to characterize preparedness for survivorship. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.
Measured: At baseline and up to 3 month phone call
Patient self-efficacy
Descriptive statistics will be used to characterize patient self-efficacy. Results will be compared to previous studies, published work, and other historical cohorts. The concordance of urologists' assessment of patients' outcomes with outcomes obtained from patients will be analyzed as the percent of concordant responses, and with unweighted and weighted kappa coefficients. Parsimonious models will be favored due to the relatively small sample size.
Measured: At baseline and up to 3 month phone call
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start7 Nov 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Localized Prostate CarcinomaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), United States Department of Defense
- Responsible party
- Principal investigator, Viraj Master, Emory University
- Investigators
- Viraj Master, MD, PhD, FACS, Principal investigator, Emory University Hospital/Winship Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674863
- Sponsor's protocol ID
- STUDY00008365
- Other IDs
- NCI-2024-08650, STUDY00008365, WINSHIP6368-24, P30CA138292
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2024
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Health Literacy With a Tailored Survivorship Care Plan to Improve Access in Underserved African American Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT06674863
- Acronym / sponsor ID
- STUDY00008365
- Conditions
- Localized Prostate Carcinoma, Oligometastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), United States Department of Defense
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Nov 2024 (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.
This clinical trial compares the impact of a tailored survivorship care plan (SCP) to a standard SCP on the understanding of and access to survivorship care in black or African American patients with prostate cancer that has not spread to other parts of the body (localized) or that has spread from where it first started (primary site) to a limited number of places in the body (oligometastatic). SCPs summarize treatment history and recommendations for monitoring and maintaining health, and may also include potential long term effects of treatments received. The intention of a SCP is to help patients participate in their own health care. However, many patients have below basic levels of health literacy, meaning, they have a lower ability to obtain, communicate, process and understand basic health information and services to make health decisions. In fact, poor health literacy has been linked with worse quality of life in prostate cancer survivors. A tailored SCP includes the addition of an educational supplement based on lower reading and writing skills (low literacy) and may address health literacy barriers to understanding of treatment options and side effects. A standard SCP uses a template based on the American Society of Clinical Oncology (ASCO) guidelines for prostate cancer. A tailored SCP with low literacy educational supplements may be more effective compared to a standard SCP in improving understanding and access to survivorship care in black or African American patients with localized or oligometastatic prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- Compare outcomes after patients receive usual care from their providers with a standard SCP and after patients receive tailoring of the SCP with the low literacy educational supplement.
II. To quantify the potential benefit of tailoring the care plan and the educational supplement.
III. Compare providers' assessment of patients':
IIIa. Health literacy; IIIb. Comprehension of survivorship care recommendations; IIIc. Understanding of long term and late effects from treatment; IIId. To measures obtained from patients.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I (INTERVENTION): Patients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes.
GROUP II (CONTROL): Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (standard SCP, tailored SCP) | Experimental | Other: Educational Intervention, Other: Interview, Other: Questionnaire Administration, Other: Supportive CarePatients receive standard SCP during a provider visit and a tailored SCP with a low literacy educational supplement during a structured interview over 30-60 minutes. |
| Group II (standard SCP) | Active comparator | Other: Interview, Other: Questionnaire Administration, Other: Supportive CarePatients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Black and African American men who are disease-free after completing primary surgery and/or radiation treatment for localized or oligometastatic prostate cancer between 1 to 4 years prior to enrollment. (Race/ethnicity per medical records and self report)
- Patients who are still receiving adjuvant androgen deprivation therapy following primary radiation with non-palliative intent may be included
Key exclusion criteria (6 listed)
- Dementia or cognitive impairment per provider clinical assessment
- Unable to give informed consent in the judgement of the patient's oncology provider
- Recurrent prostate cancer after primary treatment
- Less than 18 years of age at the time of informed consent
- Diagnosis of active second malignancy requiring treatment
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: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive a low literacy educational supplement | Other | Group I (standard SCP, tailored SCP) |
| InterviewUndergo a structured interview | Other | Group I (standard SCP, tailored SCP), Group II (standard SCP) |
| Questionnaire AdministrationAncillary studies | Other | Group I (standard SCP, tailored SCP), Group II (standard SCP) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive standard SCP | Other | Group I (standard SCP, tailored SCP), Group II (standard SCP) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveReceive a tailored SCP | Other | Group I (standard SCP, tailored SCP) |
Primary outcome
Comprehension of survivorship care recommendations and prostate specific antigen surveillance
Time frame: At baseline and up to 3 month phone call
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard survivorship care plan (SCP) compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P < 0.05.
Comprehension of treatment side effects and late effects
Time frame: At baseline and up to 3 month phone call
Comprehension will be scored as dichotomous variables, correct or incorrect. The proportion of patients who correctly understand after the standard SCP compared to the proportion who correctly understand after the standard SCP + tailoring + educational support will be analyzed using a two-tailed Z-score test for equality of two proportions at a significance level of P < 0.05.
5 secondary outcomes
Access to survivorship care for late and long-term side effects
Time frame: At baseline and up to 3 month phone call
Decision regret
Time frame: At baseline and up to 3 month phone call
Change in decisional conflict
Time frame: At baseline and up to 3 month phone call
Preparedness for survivorship
Time frame: At baseline and up to 3 month phone call
Patient self-efficacy
Time frame: At baseline and up to 3 month phone call
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 30 Sep 2026.
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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.
Viraj Master, MD, PhD, FACS principal investigator
Emory University Hospital/Winship Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Interview and Questionnaire Administration in people with Localized Prostate Carcinoma and Oligometastatic Prostate Carcinoma, run by Emory University at 3 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 2 inclusion and 6 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Kerry L. Kilbridge, MD, MSc (617-632-2429, Kerry_Kilbridge@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comprehension of survivorship care recommendations and prostate specific antigen surveillance (time frame: At baseline and up to 3 month phone call). 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 30 Sep 2026.