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Recruiting NCT05487846

Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation

No phase Interventional Metastatic Prostate Carcinoma Stage III Prostate Cancer AJCC v8 Stage IV Prostate Cancer AJCC v8

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient Navigation, Genetic Counseling, Survey Administration, Best Practice.
Who it may be relevant to
Registry conditions: Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation

Overview

This clinical trial evaluates whether having a trained peer navigator helps African American men with prostate cancer that has spread to other parts of the body (metastatic) understand and navigate the genetic testing process better than not having a peer navigator. Genetic testing for men with prostate cancer is very important for making treatment and management decisions. However, understanding the risks, benefits, and steps of genetic counseling and testing can be very challenging for patients. African American men are especially less likely to participant in genetic testing due to lack of awareness or understanding, cultural beliefs, finances, or mistrust of the healthcare system. A peer navigator, someone who helps a patient through the information and the process, may be helpful to some men. This study evaluates whether having a peer navigator throughout the genetic evaluation process helps patients understand and engage in the process more.

Detailed description

PRIMARY OBJECTIVES:

I. Develop a peer-based navigation program for African American (AA) men with prostate cancer (PCA).

II. Conduct a pilot study of peer-navigated genetic evaluation vs. standard clinical care and assess feasibility of peer navigation.

SECONDARY OBJECTIVE:

I. Evaluating the intervention effects on decisional conflict and PCA genetics knowledge.

EXPLORATORY OBJECTIVE:

I. Assessing trust of the healthcare system and satisfaction with the genetic evaluation process.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive assistance from a peer navigator during genetic evaluation processes. Peer navigators help patients schedule counseling appointments, discuss questions and concerns about testing, assist in saliva collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.

ARM II: Patients receive standard care during genetic evaluation processes. Patients receive genetic counseling, undergo genetic testing, schedule a post-test disclosure visit, and receive their genetic test results and recommendations per standard care.

Interventions

  • Behavioral Patient Navigation
    Receive peer navigation services
  • Other Genetic Counseling
    Receive genetic counseling
  • Other Survey Administration
    Ancillary studies
  • Other Best Practice
    Receive standard care
  • Other Genetic Counseling
    Receive genetic counseling
  • Other Survey Administration
    Ancillary studies

Primary outcome measures

  • Frequency of pretest genetic counseling engagement [Time frame: Up to 4 years]
Secondary outcome measures (2)
  • Mean changes in decisional conflict for genetic testing [Time frame: Up to 4 years]
  • Mean changes in knowledge of cancer genetics [Time frame: Up to 4 years]

Eligibility criteria

Inclusion criteria

  • Provide signed and dated informed consent form
  • English speaking only
  • Willing to comply with all study procedures and be available for the duration of the study
  • Any individual >= 18 years old
  • African American men who meet National Comprehensive Cancer Network (NCCN) criteria for testing will be offered participation. These criteria include any one of the following: (1) metastatic prostate cancer (PCA); (2) intraductal or ductal pathology; (3) T3a or higher; (4) grade group 4 or Gleason 8 or higher; (5) family history of breast, ovarian, prostate, pancreatic, colorectal, or uterine cancers in 3 or more blood relatives particularly if diagnosed at age < 50. These criteria have been adapted from the NCCN Prostate Cancer (version 2.2021) and NCCN Breast, Ovarian, and Pancreatic (version 2.2021) guideline

Exclusion criteria

  • Patients that do not meet the inclusion criteria and children under the age of 18 will be excluded
  • Anyone who has trouble understanding the consent or with significant anxiety detected during the consent process will also be excluded

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia

Identifiers

NCT: NCT05487846 · 21F.686 · JT 17263 · PC200282

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗