Hereditary Cancer SyndromesNCT06654466
Closing the GAPS: Guideline Adherence, Prevention and Surveillance in Hereditary Cancer
A study testing Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale. in people with Hereditary Cancer Syndromes and Clinical Decision Support, run by Nest Genomics at 1 site in United States.
Trial summary
The goal of this clinical trial is to see if a software platform can improve cancer screening in young adults with genetic risk for cancer. The trial will also help improve the software platform (Nest). Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Hereditary Cancer Syndromes, Clinical Decision Support
- What is being tested?
- Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-49 years, inclusive
- previous cancer genetic testing with a finding of a pathogenic or likely pathogenic variant resulting in an increased risk of cancer warranting clinical management.
- English-speaking and -reading
- Receiving care at Dana Farber Cancer Institute
- Not in active cancer therapy at the time of approach
Who cannot join
- Age <18 or >49 years
- Has not had genetic testing for hereditary cancer syndromes or has been tested but no pathogenic or likely pathogenic variant was identified.
- Non-English speaking and reading
- Not receiving care at Dana Farber Cancer Institute
- Active cancer with therapy in progress
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
The goal of this clinical trial is to see if a software platform can improve cancer screening in young adults with genetic risk for cancer.
The trial will also help improve the software platform (Nest). The main questions it aims to answer are:
Read more
- Do Nest users know more about their cancer risks and recommended care than non-users?
- Do Nest users have less psychological distress than non-users?
- Do Nest users share cancer risks with family and other doctors more than non-users?
- Are Nest users more likely than non-users to have up-to-date care plans?
Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening.
Participants will:
- Have a genetic counseling or follow up visit
- Take a post-visit survey
- Intervention arm only: use the Nest Patient Navigator
- Complete screening and follow-up care recommended by doctors
Read the detailed description
The overall objective of this project is to refine and study Nest, a software platform that integrates genetic data into patient care, with a goal of improving adherence to recommended care and empowering patients and clinicians to utilize genetic information longitudinally. Nest stores structured genetic results in the electronic medical record (EMR) and provides an interface for clinicians to order guidelines-based, personalized care plans with automated charting. For patients, the mobile friendly platform serves as a secure tool to store results, understand risks and recommended care, adhere to care, and share results with at-risk relatives. To facilitate continuity of care, patients can share genetic results and care plans with other clinicians. For this application, the investigators propose two phases. During Phase 1, the investigators will pilot the EMR-integrated Nest platform to ensure that the intervention is feasible and acceptable to clinicians and patients. Phase 2 will test Nest efficacy to improve patient and clinician experiences and outcomes, including patient knowledge of cancer risks and recommended care, and will assess implementation outcomes to facilitate future dissemination. The investigators will leverage a team with complementary expertise in genomic data, business, software development, and care of young adults with cancer risk. This team has already successfully collaborated in development of a patient-facing intervention for adolescents and young adults (AYAs) with cancer risk syndromes, and now seeks to meet the critical need for integrated and coordinated care, crossing patients, clinicians, and health systems. The long-term goal of this application is to harness an EMR integrated platform to improve care and outcomes for AYAs with cancer risk syndromes, as an initial step toward genomic data integration for an ever-increasing array of conditions with clinical implications.
Phase 1 Aims:
Aim 1: Pilot Nest among 20 young adult hereditary cancer patients and up to 20 clinicians, refining implementation to ensure feasibility and acceptability. Our working hypothesis is that the Nest intervention will be feasible and acceptable to patients and clinicians.
Phase 2 Aims:
In Phase 2, the investigators will Implement the Nest intervention by conducting a randomized trial at a single large cancer center and its associated community-based satellites.
Aim 1: Measure the impact of the Nest intervention on patient knowledge of cancer risk and recommended care, psychological distress, and information sharing with family and clinicians.
Our working hypothesis is that patients assigned to the Nest intervention will have increased knowledge of cancer risks and recommended care, without increased psychological distress, and will have increased frequency of information sharing with family and other clinicians.
Aim 2: Examine impact of the Nest intervention on clinician behavior, including guideline-concordant orders and referrals as well as EMR documentation. Our working hypothesis is that patients assigned to the Nest intervention will have higher rates of guidelines-concordant orders and referrals and Nest Clinical Decision Support (CDS) summaries in EMR documentation.
Aim 3: Evaluate implementation outcomes, including patient and clinician utilization of Nest features, to facilitate future dissemination. The investigators will examine the frequency of utilization of Nest features, including patient access and sharing of information and clinician use of orders and documentation templates, to assess features that are most useful and/or in need of further refinement.
Impact: At the completion of the proposed research, our expected outcomes are: to have a refined platform that results in increased knowledge, information sharing, and guidelines concordant care.
- Being tested
- Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.
- Keywords
- Hereditary Cancer Syndromes, Cancer Surveillance, Cancer Prevention, Guideline Adherence, Clinical Decision Support, Adolescent and Young Adult Cancer
- Medical subject headings
- Neoplastic Syndromes, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.Device
The Nest software platform includes the Nest Care Studio, Nest Patient Navigator and the Analytics Dashboard. Nest Care Studio is a clinician facing portal that can be used standalone or electronic medical record (EMR) integrated. Care Studio enables clinicians to effectively manage patients' genetic information over time. Clinicians can see a list of patients that meet criteria for testing, run risk assessment calculations, order genetic tests, manage patients based on results and view education modules.The Nest Patient Navigator is a secure mobile device accessible platform that provides a centralized location for patients to store, manage, and follow-up with their genetic results. The Analytics Dashboard is an interactive dashboard that can track outcomes of genomic programs and trigger interventions to optimize them.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey. |
| Intervention Arm | Experimental | Patients in the intervention arm will complete a genetic counseling or follow-up visit with a clinician using Nest Clinical Decision Support and a post visit-survey. Intervention arm patients will be given access to the Nest Patient Navigator. Receives: Device: Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention Measure (AIM)
A 4-item measure of intervention acceptability on a 5-point Likert response scale designed for a range of stakeholders. Demonstrated to be associated with intervention success.
Measured: within 7 days of visit
Gist Comprehension of Genetic Cancer Risk
Modified items from the Gist Comprehension of Genetic Cancer Risk (alpha=.85) ask patients their likelihood of future cancer on a 5-point Likert scale, higher score indicating greater comprehension.
Measured: Baseline, within 7 days of visit
Knowledge of Cancer Screening
An 11-item true-false scale (Cronbach's alpha=.81) will measure knowledge of cancer screening recommendations. Higher score indicates greater knowledge, minimum score=0, maximum score=11. Items will be modified for cancer risk syndromes under study.
Measured: Baseline, within 7 days of visit
Psychosocial Aspects of Hereditary Cancer (PAHC)
A 26-item questionnaire organized into six problem domains: genetics, practical issues, family, living with cancer, emotions, and children. Higher score indicates greater emotional distress. Validated in adults with hereditary cancer risk.
Measured: Baseline, within 7 days of visit
Distress Thermometer (DT)
A visual-analog scale from 0-"no distress" to 10-"extreme distress" to assess general psychological distress. Higher score indicates greater distress. Pairing with the PAHC enhances sensitivity and specificity.
Measured: Baseline, within 7 days of visit
Secondary outcomes (1)
Uncertainty of Illness Measures
self-report - Mischel Illness Uncertainty Scale (Cronbach's α=.74-.92).5-point Likert scale ranging from "Strongly Agree" to "Strongly Disagree". Higher scores indicate greater uncertainty.
Measured: Baseline, within 7 days of visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start10 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Cancer SyndromesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nest Genomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, National Human Genome Research Institute (NHGRI)
- Responsible party
- Sponsor
- Investigators
- Huma Q Rana, MD, Principal investigator, Dana-Farber Cancer InstituteJennifer W Mack, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654466
- Sponsor's protocol ID
- 22-657
- Other IDs
- 1R42HG013908-01
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
- ClinicalTrials.gov ID
- NCT06654466
- Acronym / sponsor ID
- 22-657
- Keywords
- Hereditary Cancer Syndromes, Cancer Surveillance, Cancer Prevention, Guideline Adherence, Clinical Decision Support, Adolescent and Young Adult Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nest GenomicsIndustry (pharma, biotech, devices)
- Collaborators
- Dana-Farber Cancer Institute, National Human Genome Research Institute (NHGRI)
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Oct 2024 (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.
The goal of this clinical trial is to see if a software platform can improve cancer screening in young adults with genetic risk for cancer.
The trial will also help improve the software platform (Nest). The main questions it aims to answer are:
- Do Nest users know more about their cancer risks and recommended care than non-users?
- Do Nest users have less psychological distress than non-users?
- Do Nest users share cancer risks with family and other doctors more than non-users?
- Are Nest users more likely than non-users to have up-to-date care plans?
Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening.
Participants will:
- Have a genetic counseling or follow up visit
- Take a post-visit survey
- Intervention arm only: use the Nest Patient Navigator
- Complete screening and follow-up care recommended by doctors
Detailed description
The overall objective of this project is to refine and study Nest, a software platform that integrates genetic data into patient care, with a goal of improving adherence to recommended care and empowering patients and clinicians to utilize genetic information longitudinally. Nest stores structured genetic results in the electronic medical record (EMR) and provides an interface for clinicians to order guidelines-based, personalized care plans with automated charting. For patients, the mobile friendly platform serves as a secure tool to store results, understand risks and recommended care, adhere to care, and share results with at-risk relatives. To facilitate continuity of care, patients can share genetic results and care plans with other clinicians. For this application, the investigators propose two phases. During Phase 1, the investigators will pilot the EMR-integrated Nest platform to ensure that the intervention is feasible and acceptable to clinicians and patients. Phase 2 will test Nest efficacy to improve patient and clinician experiences and outcomes, including patient knowledge of cancer risks and recommended care, and will assess implementation outcomes to facilitate future dissemination. The investigators will leverage a team with complementary expertise in genomic data, business, software development, and care of young adults with cancer risk. This team has already successfully collaborated in development of a patient-facing intervention for adolescents and young adults (AYAs) with cancer risk syndromes, and now seeks to meet the critical need for integrated and coordinated care, crossing patients, clinicians, and health systems. The long-term goal of this application is to harness an EMR integrated platform to improve care and outcomes for AYAs with cancer risk syndromes, as an initial step toward genomic data integration for an ever-increasing array of conditions with clinical implications.
Phase 1 Aims:
Aim 1: Pilot Nest among 20 young adult hereditary cancer patients and up to 20 clinicians, refining implementation to ensure feasibility and acceptability. Our working hypothesis is that the Nest intervention will be feasible and acceptable to patients and clinicians.
Phase 2 Aims:
In Phase 2, the investigators will Implement the Nest intervention by conducting a randomized trial at a single large cancer center and its associated community-based satellites.
Aim 1: Measure the impact of the Nest intervention on patient knowledge of cancer risk and recommended care, psychological distress, and information sharing with family and clinicians.
Our working hypothesis is that patients assigned to the Nest intervention will have increased knowledge of cancer risks and recommended care, without increased psychological distress, and will have increased frequency of information sharing with family and other clinicians.
Aim 2: Examine impact of the Nest intervention on clinician behavior, including guideline-concordant orders and referrals as well as EMR documentation. Our working hypothesis is that patients assigned to the Nest intervention will have higher rates of guidelines-concordant orders and referrals and Nest Clinical Decision Support (CDS) summaries in EMR documentation.
Aim 3: Evaluate implementation outcomes, including patient and clinician utilization of Nest features, to facilitate future dissemination. The investigators will examine the frequency of utilization of Nest features, including patient access and sharing of information and clinician use of orders and documentation templates, to assess features that are most useful and/or in need of further refinement.
Impact: At the completion of the proposed research, our expected outcomes are: to have a refined platform that results in increased knowledge, information sharing, and guidelines concordant care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey. |
| Intervention Arm | Experimental | Device: Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.Patients in the intervention arm will complete a genetic counseling or follow-up visit with a clinician using Nest Clinical Decision Support and a post visit-survey. Intervention arm patients will be given access to the Nest Patient Navigator. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Ages 18-49 years, inclusive
- previous cancer genetic testing with a finding of a pathogenic or likely pathogenic variant resulting in an increased risk of cancer warranting clinical management.
- English-speaking and -reading
- Receiving care at Dana Farber Cancer Institute
- Not in active cancer therapy at the time of approach
Key exclusion criteria (5 listed)
- Age <18 or >49 years
- Has not had genetic testing for hereditary cancer syndromes or has been tested but no pathogenic or likely pathogenic variant was identified.
- Non-English speaking and reading
- Not receiving care at Dana Farber Cancer Institute
- Active cancer with therapy in progress
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 |
|---|---|---|
| Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale.The Nest software platform includes the Nest Care Studio, Nest Patient Navigator and the Analytics Dashboard. Nest Care Studio is a clinician facing portal that can be used standalone or electronic medical record (EMR) integrated. Care Studio enables clinicians to effectively manage patients' genetic information over time. Clinicians can see a list of patients that meet criteria for testing, run risk assessment calculations, order genetic tests, manage patients based on results and view education modules.The Nest Patient Navigator is a secure mobile device accessible platform that provides a centralized location for patients to store, manage, and follow-up with their genetic results. The Analytics Dashboard is an interactive dashboard that can track outcomes of genomic programs and trigger interventions to optimize them. | Device | Intervention Arm |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: within 7 days of visit
A 4-item measure of intervention acceptability on a 5-point Likert response scale designed for a range of stakeholders. Demonstrated to be associated with intervention success.
Gist Comprehension of Genetic Cancer Risk
Time frame: Baseline, within 7 days of visit
Modified items from the Gist Comprehension of Genetic Cancer Risk (alpha=.85) ask patients their likelihood of future cancer on a 5-point Likert scale, higher score indicating greater comprehension.
Knowledge of Cancer Screening
Time frame: Baseline, within 7 days of visit
An 11-item true-false scale (Cronbach's alpha=.81) will measure knowledge of cancer screening recommendations. Higher score indicates greater knowledge, minimum score=0, maximum score=11. Items will be modified for cancer risk syndromes under study.
Psychosocial Aspects of Hereditary Cancer (PAHC)
Time frame: Baseline, within 7 days of visit
A 26-item questionnaire organized into six problem domains: genetics, practical issues, family, living with cancer, emotions, and children. Higher score indicates greater emotional distress. Validated in adults with hereditary cancer risk.
Distress Thermometer (DT)
Time frame: Baseline, within 7 days of visit
A visual-analog scale from 0-"no distress" to 10-"extreme distress" to assess general psychological distress. Higher score indicates greater distress. Pairing with the PAHC enhances sensitivity and specificity.
1 secondary outcome
Uncertainty of Illness Measures
Time frame: Baseline, within 7 days of visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Nest GenomicsLink provided by the sponsor.
- 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.
Huma Q Rana, MD principal investigator
Dana-Farber Cancer Institute
Jennifer W Mack, MD principal investigator
Dana-Farber 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 Nest, an electronic medical record (EMR)-integrated software platform to deliver longitudinal, genetics-based care at scale. in people with Hereditary Cancer Syndromes and Clinical Decision Support, run by Nest Genomics 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 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?
This study is still under way. Results are not available in the source record yet.
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?
Acceptability of Intervention Measure (AIM) (time frame: within 7 days of visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.