Personalized Oncology Promoting Equity for Black Lives

Genetic Testing Clinical Trial

— PROPEL  

Official title:

Personalized Oncology Promoting Equity for Black Lives

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073626
• Other study ID #: Pro2022001513
• Secondary ID: R01CA277599
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: August 31, 2027

Study information

• Verified date: May 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Erin Speiser, PhD, MA
• Phone: 732-675-1668
• Email: erin.speiser[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will:

1. Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing.

2. Evaluate the impact of the chatbot vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).

3. Explore the ways (methods) that influence how participants experience the intervention.

The main questions this study aims to answer are which group - the chatbot (RA) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.

Participants will be randomly assigned to either the chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.

Description:

Research Design and Methods:

This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the RA intervention compared to EUC among 428 Black cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the RA intervention on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3).

Research Procedures:

The design for this study is a 2-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC) or RA. Randomization will be balanced in a 1:1 ratio - with 214 participants randomized to each arm. Because this study is designed to address the disparity of low genetic testing utilization in Black cancer patients, all study participants will be Black and approximately 10% will be Hispanic.

The investigators will utilize the EHRs at our participating sites to identify cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute of NJ (Rutgers CINJ New Brunswick and Rutgers CINJ Newark) including RWJ Barnabas Health community oncology sites. Participants will be women and men who self-identify as Black or African American, have a history of breast, ovarian, uterine, colorectal, prostate, or pancreatic cancer, are at least six-months post-diagnosis, and have received treatment or follow-up oncology care at one of the participating sites in the prior two years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 428
• Est. completion date: August 31, 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 18-80 years of age

• Identify as Black or African American

• At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic

• Have received treatment or follow-up oncology care at one of the participating sites in the prior two years.

• Meet National Comprehensive Cancer Network criteria for germline GT

• Able to read and speak in English.

Exclusion Criteria:

• Do not speak English

• Unable to access the Internet

• Have previously undergone germline genetic testing for hereditary cancer risk

• Are unable to provide informed consent

Related Conditions & MeSH terms

• Genetic Testing
• Hereditary Cancer

Intervention

Behavioral:
• Relational agent (RA) / Chatbot
Consists of clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors.
• Enhanced Usual Care (EUC)
Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors.

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute	New Brunswick	New Jersey
United States	Georgetown Lombardi Comprehensive Cancer Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Georgetown University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of Germline Genetic Testing	As captured via internal RedCap form for the number or count of participants who opt for genetic testing, the investigators will test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic testing uptake;	6-months
Primary	Survey Assessment of Impact of RA vs. EUC	Evaluate the impact of the RA vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.	1-month and 6-month survey
Primary	Survey Assessment of Mediators and Moderators of Efficacy	Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys. Multiple scales are used to measure this outcome and each scale has a unique scoring system.	Baseline, 1-month and 6-month surveys
Secondary	Survey Assessment of Engagement with Genetic Education	Engagement with genetic education/counseling via survey measures of related constructs at 1-month survey. Multiple scales are used to measure this outcome and each scale has a unique scoring system.	1-month survey