To hear about similar clinical trials, please enter your email below
Trial Title:
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
NCT ID:
NCT05487846
Condition:
Metastatic Prostate Carcinoma
Stage III Prostate Cancer AJCC v8
Stage IV Prostate Cancer AJCC v8
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Navigation
Description:
Receive peer navigation services
Arm group label:
Arm I (peer navigation)
Other name:
Patient Navigator Program
Intervention type:
Other
Intervention name:
Genetic Counseling
Description:
Receive genetic counseling
Arm group label:
Arm I (peer navigation)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (peer navigation)
Intervention type:
Other
Intervention name:
Best Practice
Description:
Receive standard care
Arm group label:
Arm II (best practice)
Other name:
standard of care
Other name:
standard therapy
Intervention type:
Other
Intervention name:
Genetic Counseling
Description:
Receive genetic counseling
Arm group label:
Arm II (best practice)
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm II (best practice)
Summary:
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.
Criteria for 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
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 14, 2024
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Thomas Jefferson University
Agency class:
Other
Source:
Thomas Jefferson University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05487846
