Choices About Genetic Testing And Learning Your Risk With Smart Technology

Overview

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.

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.

Eligibility

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.