Recruiting

Tailored SCP

Sponsor:

Emory University

Code:

NCT06674863

Conditions

Localized Prostate Carcinoma

Oligometastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Educational Intervention

Interview

Questionnaire Administration

Supportive Care

Supportive Care

Study Details

Brief 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 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.

Conditions

Localized Prostate Carcinoma

Oligometastatic Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT06674863

Start date

Nov 7, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Group I (standard SCP, tailored SCP)

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.

active comparator: Group II (standard SCP)

Patients receive standard SCP using the prostate cancer ASCO template during a provider visit and undergo a structured interview over 30-60 minutes.

Interventions

Educational Intervention

Receive a low literacy educational supplement

Interview

Undergo a structured interview

Questionnaire Administration

Ancillary studies

Supportive Care

Receive standard SCP

Supportive Care

Receive a tailored SCP

Primary outcome measure

  • Comprehension of survivorship care recommendations and prostate specific antigen surveillance [ Time Frame: At baseline and up to 3 month phone call ]
  • Comprehension of treatment side effects and late effects [ Time Frame: At baseline and up to 3 month phone call ]

Central Contacts and Locations

Central contacts

Locations

Grady Memorial Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Principal Investigator:

Viraj Master, MD, PhD, FACS

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Principal Investigator:

Viraj Master, MD, PhD, FACS

Atlanta VA Medical Center

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Principal Investigator:

Viraj Master, MD, PhD, FACS

More Information

Sponsor

Emory University

Last update posted

Dec 9, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-09.