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Behavioural Intervention

Survivorship Care Plan for Prostate Cancer

N/A

Recruiting

Led By Viraj Master

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Recurrent prostate cancer after primary treatment

Less than 18 years of age at the time of informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and up to 3 month phone call

Awards & highlights

No Placebo-Only Group

Summary

This trial compares how well a personalized survivorship care plan with extra educational materials helps African American patients with localized or oligometastatic prostate cancer understand and access their care, compared to a standard care plan

Who is the study for?

This trial is for Black or African American patients with prostate cancer that's either localized or has spread to a few other places (oligometastatic). It aims to help those who may struggle with health literacy, which means they find it hard to understand and act on medical information.

What is being tested?

The study compares two types of survivorship care plans (SCPs): a standard one based on ASCO guidelines and a tailored version designed for easier understanding by people with lower reading skills. The goal is to see if the tailored SCP improves patient comprehension and access to ongoing healthcare.

What are the potential side effects?

Since this trial involves educational materials and interviews rather than medications, there are no direct medical side effects. However, participants might experience discomfort discussing personal health issues during interviews.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has come back after initial treatment.

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I am under 18 years old.

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I am being treated for another type of cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and up to 3 month phone call

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and up to 3 month phone call

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and up to 3 month phone call for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comprehension of survivorship care recommendations and prostate specific antigen surveillance

Comprehension of treatment side effects and late effects

Secondary study objectives

Access to survivorship care for late and long-term side effects

Change in decisional conflict

Decision regret

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (standard SCP, tailored SCP)Experimental Treatment4 Interventions

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: Group II (standard SCP)Active Control3 Interventions

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

0 / 3Eligibility criteria met