Breast Cancer, Colorectal Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Pancreas Cancer, Peritoneal Cancer, Prostate Cancer
Conditions
Keywords
hereditary cancer, genetic testing, genetic education, relational agent, chatbot
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 36 individuals (18 EUC, 18 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.
Interventions
BEHAVIORALRelational Agent (RA)
Consists of a clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among cancer survivors.
BEHAVIORALEnhanced Usual Care (EUC)
Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors.
Sponsors
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
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 36 participants for pilot testing.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genetic Testing (GT) Uptake | 1-month, 6-month follow-up | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of the Relational Agent (RA) | 1-month follow-up | Acceptability will be assessed using the Chatbot Usability Questionnaire (CUQ), which evaluates key aspects of the chatbot, including its personality, onboarding process, user experience, and error handling. The CUQ consists of 16 items, each rated on a 5-point Likert scale (1 = Strongly Disagree to 5 = Strongly Agree), with scores ranging from 16 to 80. These scores will be normalized to a scale of 100. A CUQ score of 68 or higher will indicate acceptable usability. |
| Genetic Testing (GT) Intentions | Baseline, 1-month, 6-month follow-up | GT intentions will be assessed using a single-item question based on the Ottawa Decision Support Framework, with six options that assess participants' readiness to engage in decision-making, ranging from not considering the choices to having already made a decision and being unlikely to change. This operationalization captures the concept of reactance to health messaging, an EPPM construct. |
| Informed Decision-Making Indicators | Baseline, 1-month, 6-month follow-up | Hereditary Cancer Knowledge will assess understanding of hereditary cancer, inheritance patterns, risk factors, and genetic testing implications using a 10-item Knowledge Index based on ASCO guidelines. Response options include "Agree," "Disagree," or "I don't know." Decision Conflict will be measured with a 12-item scale on uncertainty, being informed, personal values, and support in decision-making, plus 4 items on decision quality. Items are rated on a 5-point Likert scale (Cronbach's alpha = 0.78). Decision Regret will be assessed using a 5-item scale on distress/remorse post-decision (Cronbach's alpha = 0.81-0.92). Decision Satisfaction will use a 6-item scale (Cronbach's alpha = 0.86). Psychological distress will be assessed using the PROMIS anxiety and depression subscales. Health Beliefs will assess Perceived Susceptibility, Self-Efficacy for genetic testing, and Response Efficacy using 4 items per subscale (Cronbach's alpha = 0.85-0.93). |
| Genetic Counseling (GC) Uptake | 1-month, 6-month follow-up | GC uptake will be defined as the proportion of participants who undergo genetic counseling within 6 months of the baseline survey (for both the EUC and RA arms). This will be verified through medical record documentation. Self-reported GC will be tracked if verification is not feasible. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnita Y Kinney, PhD, RN
Director at Rutgers Cancer Institute
Outcome results
None listed