Ovarian CancerCATALYSTNCT06184867
Choices About Genetic Testing And Learning Your Risk With Smart Technology
A study testing Relational Agent (RA) in people with Ovarian Cancer and Fallopian Tube Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Relational Agent (RA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- User/Usability Testing
- Age 18 or older
- Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
- Speak/read and understand English
- Capable of providing informed consent
- Have Internet access (via smartphone, tablet, or computer)
Show all 13Show fewer
- Randomized Feasibility Trial
- Age 18 or older
- Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
- Meet National Comprehensive Cancer Network (NCCN) criteria for germline GT
- Speak/read and understand English
- Capable of providing informed consent
- Have Internet access (via smartphone, tablet or computer)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant [RA]).
- 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.
- 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.
Read the 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.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer, Pancreas Cancer, Colorectal Cancer
- Being tested
- Relational Agent (RA), Enhanced Usual Care (EUC)
- Keywords
- hereditary cancer, genetic testing, genetic education, relational agent, chatbot
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms, Breast Neoplasms, Pancreatic Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational Agent (RA)Behavioural
Also called Alex, Chatbot, Digital health tool, Decision support tool
Consists of a clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among cancer survivors.
Enhanced Usual Care (EUC)Behavioural
Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors.
| Study group | Role | What they receive |
|---|---|---|
| Relational Agent (RA) | Experimental | Participants in the RA arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program with a link to the HIPAA-compliant RA. The RA will provide educational content equivalent to traditional genetic counseling (GC) in a streamlined format, including videos, decision support, patient testimonials, and real-time Q\&A. Participants will be informed that they can consult with a genetic risk specialist at no cost. Those opting for genetic testing (GT) will have a kit mailed to them, with results shared with the participant and their oncologist, tailored to the findings. Participants undecided or unwilling to proceed with GT will be encouraged by the RA to consult their oncology provider and/or schedule a GC appointment. Receives: Behavioral: Relational Agent (RA) |
| Enhanced Usual Care (EUC) | Active comparator | Participants in the EUC arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter will inform participants of their and their family's potential risk for carrying a pathogenic variant (PV) associated with hereditary cancer. It will emphasize their eligibility for genetic testing (GT), recommend considering a genetic counseling (GC) appointment for further information, and provide a link to the Rutgers Cancer Institute high-risk clinic website. The study team will assist in facilitating GT upon request. Results will be shared with the participant and their oncologist and tailored according to the findings. Receives: Behavioral: Enhanced Usual Care (EUC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic Testing (GT) Uptake
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.
Measured: 1-month, 6-month follow-up
Secondary outcomes (4)
Acceptability of the Relational Agent (RA)
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.
Measured: 1-month follow-up
Genetic Testing (GT) Intentions
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.
Measured: Baseline, 1-month, 6-month follow-up
Informed Decision-Making Indicators
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).
Measured: Baseline, 1-month, 6-month follow-up
Genetic Counseling (GC) Uptake
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.
Measured: 1-month, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start26 Sep 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Y. Kinney, PhD, RN, Rutgers, The State University of New Jersey
- Investigators
- Anita Y Kinney, PhD, RN, Principal investigator, Director at Rutgers Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184867
- Sponsor's protocol ID
- 132307
- Other IDs
- Pro2023000964
- Acronym
- CATALYST
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tundealao S, Heidt E, Grumet S, Schwartz MD, Peshkin BN, An J, Walters ST, O'Boyle L, Toppmeyer D, Kinney AY. Development and feasibility testing of a conversational chatbot supporting genetic education and testing for hereditary cancer. J Community Genet. 2026 Jun 22;17(3):49. doi: 10.1007/s12687-026-00873-z.
PubMed 42332242
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choices About Genetic Testing And Learning Your Risk With Smart Technology
- ClinicalTrials.gov ID
- NCT06184867
- Acronym / sponsor ID
- CATALYST / 132307
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Breast Cancer, Pancreas Cancer, Colorectal Cancer
- Keywords
- hereditary cancer, genetic testing, genetic education, relational agent, chatbot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Finalize the development and optimize the usability of the CATALYST digital intervention (also known as the relational assistant [RA]).
- 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.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Relational Agent (RA) | Experimental | Behavioral: Relational Agent (RA)Participants in the RA arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program with a link to the HIPAA-compliant RA. The RA will provide educational content equivalent to traditional genetic counseling (GC) in a streamlined format, including videos, decision support, patient testimonials, and real-time Q\&A. Participants will be informed that they can consult with a genetic risk specialist at no cost. Those opting for genetic testing (GT) will have a kit mailed to them, with results shared with the participant and their oncologist, tailored to the findings. Participants undecided or unwilling to proceed with GT will be encouraged by the RA to consult their oncology provider and/or schedule a GC appointment. |
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)Participants in the EUC arm will receive a clinical letter signed by the Medical Director of the institution's clinical genetics program. The letter will inform participants of their and their family's potential risk for carrying a pathogenic variant (PV) associated with hereditary cancer. It will emphasize their eligibility for genetic testing (GT), recommend considering a genetic counseling (GC) appointment for further information, and provide a link to the Rutgers Cancer Institute high-risk clinic website. The study team will assist in facilitating GT upon request. Results will be shared with the participant and their oncologist and tailored according to the findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- User/Usability Testing
- Age 18 or older
- Diagnosed with ovarian, fallopian tube, peritoneal, breast, pancreatic, colorectal, endometrial or prostate cancer
- Speak/read and understand English
- Capable of providing informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Agent (RA)Also: Alex, Chatbot, Digital health tool, Decision support toolConsists of a clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among cancer survivors. | Behavioural | Relational Agent (RA) |
| Enhanced Usual Care (EUC)Consists of a clinical letter and recommendation for genetic testing for hereditary cancer risk among cancer survivors. | Behavioural | Enhanced Usual Care (EUC) |
Primary outcome
Genetic Testing (GT) Uptake
Time frame: 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.
4 secondary outcomes
Acceptability of the Relational Agent (RA)
Time frame: 1-month follow-up
Genetic Testing (GT) Intentions
Time frame: Baseline, 1-month, 6-month follow-up
Informed Decision-Making Indicators
Time frame: Baseline, 1-month, 6-month follow-up
Genetic Counseling (GC) Uptake
Time frame: 1-month, 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Derived from this study: PubMed 42332242Tundealao S, Heidt E, Grumet S, Schwartz MD, Peshkin BN, An J, Walters ST, O'Boyle L, Toppmeyer D, Kinney AY. Development and feasibility testing of a conversational chatbot supporting genetic education and testing for hereditary cancer. J Community Genet. 2026 Jun 22;17(3):49. doi: 10.1007/s12687-026-00873-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Y Kinney, PhD, RN principal investigator
Director at Rutgers Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Relational Agent (RA) in people with Ovarian Cancer and Fallopian Tube Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic Testing (GT) Uptake (time frame: 1-month, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.