Back to resultsPeer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
Primary Purpose
Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Patient Navigation
Genetic Counseling
Survey Administration
Best Practice
Genetic Counseling
Survey Administration
Sponsored by
About this trial
This is an interventional supportive care trial for Metastatic Prostate Carcinoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm I (peer navigation)
Arm II (best practice)
Arm Description
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 sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.
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.
Outcomes
Primary Outcome Measures
Frequency of pretest genetic counseling engagement
Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.
Secondary Outcome Measures
Mean changes in decisional conflict for genetic testing
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Mean changes in knowledge of cancer genetics
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Full Information
NCT ID
NCT05487846
First Posted
August 2, 2022
Last Updated
October 26, 2022
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05487846
Brief Title
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
Official Title
ADVANTAGE: Addressing Disparities for Veterans and African Americans Through Peer-Navigation for Testing and Genetic Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 14, 2022 (Anticipated)
Primary Completion Date
April 7, 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Carcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (peer navigation)
Arm Type
Experimental
Arm Description
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 sample collection, schedule a post-test disclosure visit, and do a results and recommendations debrief.
Arm Title
Arm II (best practice)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Other Intervention Name(s)
Patient Navigator Program
Intervention Description
Receive peer navigation services
Intervention Type
Other
Intervention Name(s)
Genetic Counseling
Intervention Description
Receive genetic counseling
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard care
Intervention Type
Other
Intervention Name(s)
Genetic Counseling
Intervention Description
Receive genetic counseling
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Frequency of pretest genetic counseling engagement
Description
Compared between randomized study groups. Tested using a chi-square test. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.
Time Frame
Up to 4 years
Secondary Outcome Measure Information:
Title
Mean changes in decisional conflict for genetic testing
Description
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Time Frame
Up to 4 years
Title
Mean changes in knowledge of cancer genetics
Description
Compared between study groups over time. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time. Evaluated using mixed effects models with fixed effects for group indicator, time, and group-by-time interaction and random intercept effects for individual.
Time Frame
Up to 4 years
Other Pre-specified Outcome Measures:
Title
Healthcare system distrust
Description
Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.
Time Frame
Up to 4 years
Title
Satisfaction with the genetic evaluation process
Description
Compared between two study arms. Summarized between study groups in tables with descriptive statistics (e.g.'s, means and standard deviations if continuous, frequencies and percentages if discrete) with 95% confidence intervals and also graphically in data plots at each time they are assessed along with changes in responses over time.
Time Frame
Up to 4 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veda Giri, MD
Phone
215-503-5253
Email
veda.giri@jefferson.edu
12. IPD Sharing Statement
Learn more about this trial
Peer Navigation for the Support of Metastatic Prostate Cancer Patients Undergoing Genetic Evaluation
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