Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Endometrial Neoplasms

Fallopian Tube Neoplasms

Urogenital Neoplasms

Genital Diseases

Urogenital Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endocrine Gland Neoplasms

Adnexal Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Endocrine System Diseases

Uterine Neoplasms

Uterine Diseases

Fallopian Tube Diseases

Pancreatic Diseases

Pancreatic Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

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

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.

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.

Relational Agent

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.

Clinical Letter

Emily K Heidt, BS

Anita Y Kinney, PhD, RN

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.

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.

This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the relational agent/chatbot (RA) intervention compared to Enhanced Usual Care (EUC) among 30 cancer survivors.

Treating clinicians will be blind their patients group assignment. While participants cannot be blinded to group, they will be blinded to the study's specific hypotheses. Statisticians and outcome assessors will be blinded to allocation.

Choices About Genetic Testing And Learning Your Risk With Smart Technology

Participants receiving Genetic Counseling and or Genetic Testing through the study will be tracked via self-report on surveys and test orders and verified by test results provided by participants. For outside Genetic Counseling and Genetic Testing, we will use self-report, validated by asking for clinic/counselor name and a copy of test report.

Measured through User and Usability testing, a 45-60-minute guided interview hosted virtually by trained Rutgers CINJ study staff and recorded on either Rutgers' HIPAA compliant Microsoft Teams or Zoom where users will interact with the Relational Agent.

User testing helps determine if the digital intervention will be used by the intended user and how the user interacts with it. This phase focuses on content related issues and obtains initial feedback on navigating the user interphase and then the Alex RA prototype will be modified accordingly.

Usability testing will help ensure that users can effectively use the RA to accomplish tasks, identify technical issues and obtain feedback on site navigation issues, and then the Alex RA prototype will be modified accordingly.

Data saturation is reached when no new information on the topic is gained.

Rutgers, The State University of New Jersey

Study Principal Investigator; Associate Director for Cancer Health Equity

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Choices About Genetic Testing And Learning Your Risk With Smart Technology	NCT06184867	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Breast Cancer Pancreas Cancer Colorectal Canc... Endometrial Can... Prostate Cancer	Relational Agen... Clinical Letter	18 Years -	Rutgers, The State University of New Jersey
Choices About Genetic Testing And Learning Your Risk With Smart Technology	NCT06184867	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Breast Cancer Pancreas Cancer Colorectal Canc... Endometrial Can... Prostate Cancer	Relational Agen... Clinical Letter	18 Years -	Rutgers, The State University of New Jersey
Choices About Genetic Testing And Learning Your Risk With Smart Technology	NCT06184867	Ovarian Cancer Fallopian Tube ... Peritoneal Canc... Breast Cancer Pancreas Cancer Colorectal Canc... Endometrial Can... Prostate Cancer	Relational Agen... Clinical Letter	18 Years -	Rutgers, The State University of New Jersey

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