Choices About Genetic Testing And Learning Your Risk With Smart Technology

NCT06184867 | Completed

• 2 other identifiers: 132307Pro2023000964
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to enhance genetic education and increase the uptake of genetic testing for hereditary cancer risk among cancer survivors. The study will focus on the feasibility and acceptability of a digital intervention designed to improve cancer genomic care. The study objectives are to:

1. 1.Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant \[RA\]).
2. 2.Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model for cancer survivors. Participants will be randomized to one of two study arms: the RA intervention arm or the enhanced usual care (EUC) arm.
3. 3.Assess the uptake of genetic counseling (GC) and genetic testing (GT) and conduct a process evaluation to identify barriers and facilitators to GC, GT, and engagement with the CATALYST intervention and the RA.

Conditions

Breast Cancer; Pancreas Cancer; Colorectal Cancer; Endometrial Cancer; Prostate Cancer; Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer

Keywords

hereditary cancer; genetic testing; genetic education; relational agent; chatbot

Outcome Measures

Primary Outcomes (1)

• Genetic Testing (GT) Uptake

  GT uptake will be defined as the proportion of participants who undergo genetic testing within 6 months of the baseline survey (for both the EUC and RA arms). This will be verified through medical record documentation. Self-reported GT will be tracked if verification is not feasible.

  1-month, 6-month follow-up

Secondary Outcomes (4)

• Acceptability of the Relational Agent (RA)

  1-month follow-up

• Genetic Testing (GT) Intentions

  Baseline, 1-month, 6-month follow-up

• Informed Decision-Making Indicators

  Baseline, 1-month, 6-month follow-up

• Genetic Counseling (GC) Uptake

  1-month, 6-month follow-up

Study Arms (2)

Relational Agent (RA)

EXPERIMENTAL

Participants in the RA arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program with a link to the HIPAA-compliant RA. The RA will provide educational content equivalent to traditional genetic counseling (GC) in a streamlined format, including videos, decision support, patient testimonials, and real-time Q\&A. Participants will be informed that they can consult with a genetic risk specialist at no cost. Those opting for genetic testing (GT) will have a kit mailed to them, with results shared with the participant and their oncologist, tailored to the findings. Participants undecided or unwilling to proceed with GT will be encouraged by the RA to consult their oncology provider and/or schedule a GC appointment.

Behavioral: Relational Agent (RA)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Participants in the EUC arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter will inform participants of their and their family's potential risk for carrying a pathogenic variant (PV) associated with hereditary cancer. It will emphasize their eligibility for genetic testing (GT), recommend considering a genetic counseling (GC) appointment for further information, and provide a link to the Rutgers Cancer Institute high-risk clinic website. The study team will assist in facilitating GT upon request. Results will be shared with the participant and their oncologist and tailored according to the findings.

Behavioral: Enhanced Usual Care (EUC)

Interventions

Relational Agent (RA) BEHAVIORAL

Consists of a clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among cancer survivors.

Also known as: Alex, Chatbot, Digital health tool, Decision support tool

Relational Agent (RA)

Enhanced Usual Care (EUC) BEHAVIORAL

Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• User/Usability Testing
• Age 18 or older
• Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
• Speak/read and understand English
• Capable of providing informed consent
• Have Internet access (via smartphone, tablet, or computer)
• Randomized Feasibility Trial
• Age 18 or older
• Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
• Meet National Comprehensive Cancer Network (NCCN) criteria for germline GT
• Speak/read and understand English
• Capable of providing informed consent
• Have Internet access (via smartphone, tablet or computer)

You may not qualify if:

• Participants will be 18 years of age or older because germline genetic testing is generally not recommended in children when the test results would not impact clinical management. Participants from the user and usability testing phases are not eligible for the feasibility trial. Feasibility trial participants cannot have previously undergone germline GT for hereditary cancer risk.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers University

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Colorectal Neoplasms; Endometrial Neoplasms; Prostatic Neoplasms

Interventions

Darbepoetin alfa

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Uterine Neoplasms; Uterine Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Anita Y Kinney, PhD, RN

  Director at Rutgers Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Treating clinicians will be blind to their patient's group assignment. While participants cannot be blinded to the group, they will be blinded to the study's specific hypotheses. Statisticians and outcome assessors will be blinded to allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director at Rutgers Cancer Institute

Model Details: This study is a 2-arm parallel-group randomized controlled trial designed to evaluate the feasibility and acceptability of the relational agent/chatbot (RA) intervention versus enhanced usual care (EUC) among cancer survivors. Randomization will occur at the patient level, with a 1:1 ratio. Phase 1 will enroll 8 participants for user testing, Phase 2 will enroll 6 participants for usability testing, and Phase 3 will enroll 36 participants for pilot testing.

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: December 28, 2023
• Study Start: September 26, 2023
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)