Clinical trial NCT06184867: Choices About Genetic Testing And Learning Your Risk With Smart Technology
Official title: Choices About Genetic Testing And Learning Your Risk With Smart Technology
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Breast Cancer
Pancreas Cancer
Colorectal Cancer
Endometrial Cancer
Prostate Cancer
Keywords: hereditary cancer
genetic testing
genetic education
relational agent
chatbot
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 31 participants for pilot testing.
Primary purpose: HEALTH_SERVICES_RESEARCH

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. Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant \[RA\]).
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. 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.

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 3) of 31 individuals (16 EUC, 15 RA 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 1 and Phase 2. Phase 3 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 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)

Randomized Feasibility Trial

1. Age 18 or older
2. Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
3. Meet National Comprehensive Cancer Network (NCCN) criteria for germline GT
4. Speak/read and understand English
5. Capable of providing informed consent
6. Have Internet access (via smartphone, tablet or computer)

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 for the feasibility trial. Feasibility trial participants cannot have previously undergone germline GT for hereditary cancer risk.

Primary outcomes:
measure: Genetic Testing (GT) Uptake
timeFrame: 1-month, 6-month follow-up
Secondary outcomes:
measure: Acceptability of the Relational Agent (RA)
timeFrame: 1-month follow-up
measure: Genetic Testing (GT) Intentions
timeFrame: Baseline, 1-month, 6-month follow-up
measure: Informed Decision-Making Indicators
timeFrame: Baseline, 1-month, 6-month follow-up
measure: Genetic Counseling (GC) Uptake
timeFrame: 1-month, 6-month follow-up
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Director at Rutgers Cancer Institute
name: Anita Y Kinney, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: