Choices About Genetic Testing And Learning Your Risk With Smart Technology

Clinicaltrials.gov ID: NCT06184867
db-list-check Status RECRUITING
b-loader Phase EARLY_PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 56

Conditions

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

Summary

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among cancer survivors.The study objectives are to:1. Finalize the development and optimize usability of the CATALYST digital intervention (i.e., also known as relational assistant (RA)) 2. Evaluate the feasibility and acceptability of a streamlined cancer genomic care delivery model in cancer survivors. Participants will be randomized to one of two study arms: the RA intervention vs. enhanced usual care (EUC) 3. Assess GC and GT uptake and conduct a process evaluation to measure barriers/facilitators to GC, GT and use of the CATALYST intervention and engagement with the RA.

Detailed Description

Research Design and Methods:

This study encompasses refinement of the digital intervention prototype through usability and user interface testing, and subsequent pilot/feasibility testing of a multi-level intervention, CATALYST, that includes a novel digital cancer genetic risk assistant that incorporates education, decision support, interactive smart technology and provides personalized information regarding hereditary cancer risk and genetic testing. The study will be comprised of three intervention testing stages: Phase 1 – User Testing; Phase 2 – Usability Testing, and Phase 3 – Pilot Testing.

User testing and usability testing will be done to refine the intervention prototype by incorporating cancer patients’ feedback during each phase. The feasibility and acceptability of the CATALYST intervention will be evaluated in a 2-armed randomized controlled pilot study (Phase III) of 30 individuals (15 in each study arm) identified as high-risk for a hereditary cancer gene mutation according to NCCN Criteria. The primary outcome of interest is GT uptake. Data will be collected via guided interviews (televideo or face-to-face in the clinic or other mutually convenient location (community center) for Phase I and Phase II. Phase III surveys will be self-administered via the internet or interviewer administered via telephone. Interviews and surveys will be comprised of open-ended and close-ended questions.

Locations

1 location Found with status Recruiting

Status

  • RECRUITING

Contact Person

Principal Investigator

  • Anita Y Kinney, PhD, RN

Eligibility Criteria

Inclusion Criteria:

* User/Usability Testing

1. Age 18 or older
2. Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
3. Speak/read and understand English
4. Capable of providing informed consent
5. Have Internet access (via smartphone, tablet, or computer)
* Feasibility Randomized Trial

1. Age 18 or older
2. Diagnosed with epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, colorectal cancer, breast cancer at age 50 or below or triple negative breast cancer at age 60 or below, pancreatic cancer, or endometrial cancer at age 50 or below, regional/metastatic/intraductal prostate cancer or prostate cancer with a Gleason score ≥7 per NCCN guidelines
3. Speak/read and understand English
4. Capable of providing informed consent
5. Have Internet access (via smartphone, tablet or computer)
6. Have not previously undergone GT for hereditary cancer predisposition

Exclusion Criteria:
* 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 to participate in the feasibility trial.

Study Plan

Relational Agent (RA)

EXPERIMENTAL

RA participants will be provided with access to Alex, the RA. After completing the RA, RA participants can proceed directly to GT.

  • DIAGNOSTIC_TEST:

    Relational Agent

    Description:

    Alex was developed as an interactive and personalized education and decision support intervention for smart devices, and guides participants through the key primary stages of assessing personal risk of hereditary cancer, providing genetic education, cancer family tree, patient testimonials, asks and answers questions and for those who choose, facilitates genetic testing, and streamlines disclosure of test results.

Enhanced Usual Care (EUC)

ACTIVE_COMPARATOR

EUC participants will be sent a clinical letter informing them of their increased risk of hereditary cancer, availability of GC and GT services, and contact information to schedule an appointment with a genetic counselor at the LIFE Center.

  • OTHER:

    Clinical Letter

    Description:

    Letter will be signed by Dr. Toppmeyer and contain a recommendation to contact the Life Center for a cancer genetic risk assessment and to consider GT.

Outcome Measures

Primary Outcome Measures

Number of Participants with Genetic Testing Uptake

Time Frame: 1-month, 6-months

Secondary Outcome Measures

Acceptance and Usability of the Relational Agent

Time Frame: Pre-Feasibility Trial

Timeline

  • Last Updated
    January 5, 2024
  • Start Date
    December 28, 2023
  • Today
    January 23, 2025
  • Completion Date ( Estimated )
    January 31, 2025

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