Genetic Predisposition to DiseaseNCT05759143
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing
A study testing Nest Platform in people with Genetic Predisposition to Disease and Genetic Predisposition, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Genetic Predisposition to Disease, Genetic Predisposition
- What is being tested?
- Nest Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 30 Nov 2026
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- YA Patients:
- Ages 18-39 years, inclusive.
- Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team.
- English-speaking and -reading.
- Receiving care at DFCI.
- Not undergoing active cancer therapy at the time of approach.
Show all 21Show fewer
- Clinicians:
- Cancer risk physicians (oncologists, gastroenterologists, geneticists), oncologists, nurse practitioners, physician assistants, or genetic counselors.
- English-speaking and -reading.
- Cares for YAs aged 18-39 with cancer risk syndromes.
- YA Patients:
- Ages 18-39 years, inclusive.
- Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team.
- English-speaking and -reading.
- Receiving care at Dana-Farber Cancer Institute.
- Did not participate in a stakeholder interview (Aim 1).
- Not undergoing active cancer therapy at the time of approach.
- Clinicians:
- Oncologists, nurse practitioners, cancer risk physicians, or genetic counselors.
- English-speaking and -reading.
- Caring for a participating YA.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
This research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS).
The name of the intervention used in this research study is:
Nest portal (electronic platform for patients and clinicians)
Read the detailed description
The goal of the electronic platform Nest is to help patients understand and manage genetic test results and recommended care and to help clinicians with access to results and recommendations, facilitating orders, and documentation. The portal has two parts, one for participants and one for clinicians.
For the first phase of the study, participants will give their feedback on the Nest portal's content and processes that will guide refinement of the portal. The Pilot phase will test the feasibility and acceptability of the intervention.
The research study procedures include a baseline survey, using the portal after receiving a brief orientation from the study team, a follow-up survey, and then a 30-minute interview.
Participants will be in this research study for up to 2 hours.
It is expected that about 40 people will take part in this research study.
The electronic platform is being developed by Nest Genomics.
- Being tested
- Nest Platform
- Keywords
- Genetic Predisposition to Disease, Genetic Predisposition, Genetic Testing, Cancer Risk Syndromes, VUS, Variant of Uncertain Significance, Pathogenic Variant
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nest PlatformBehavioural
Patient- and clinician-facing portal via secure link
| Study group | Role | What they receive |
|---|---|---|
| Nest Refinement Phase | Experimental | 20 participants and clinicians will complete study procedures as outlined:
* Nest portal orientation and access.
* Semi-structured, 30-minute interviews. Solicited feedback on content and processes will refine the intervention for a pilot phase. Receives: Behavioral: Nest Platform |
| Nest Pilot Phase | Experimental | 10 Participants and 10 clinicians will complete study procedures as outlined:
* Baseline survey (participant).
* Standard clinic visit.
* Nest portal orientation and access (participant and clinician).
* Post-visit survey (participant and clinician).
* Brief, 30-minute, semi-structured interview (participant and clinician). Receives: Behavioral: Nest Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participant Utilization (Feasibility)
Defined as > 70% of consenting participants who use the intervention.
Measured: 2 hours
Proportion of Clinician Utilization (Feasibility)
Defined as > 70% of consenting clinicians who use the intervention.
Measured: 2 hours
Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4
Defined as >70% of clinicians consider the intervention feasible as assessed by the post-visit survey.
Measured: At post-visit survey, up to 2 hours
Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4
Defined as > 70% of young adult participants consider the intervention successful as measured by a post-visit AIM score >4
Measured: At post-visit survey, up to 30 days
Proportion of Clinicians with AIM Score > 4
Defined as > 70% of clinicians consider the intervention successful as measured by a post-visit AIM score >4
Measured: at post-visit survey, up to 2 hours
Secondary outcomes (2)
Change in knowledge of cancer risk
Change in cancer knowledge will be assessed by participant survey at baseline and post visit.
Measured: Baseline and post visit up to 2 hours
Change in Recommended screening
Change in Recommended screening will be assessed by participant survey at baseline and post visit.
Measured: Baseline and post visit up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start1 May 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic Predisposition to DiseaseStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nest Genomics
- Responsible party
- Principal investigator, Jennifer Mack, MD, Dana-Farber Cancer Institute
- Investigators
- Jennifer Mack, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759143
- Sponsor's protocol ID
- 22-657
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2023
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 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
- NCT05759143
- Acronym / sponsor ID
- 22-657
- Keywords
- Genetic Predisposition to Disease, Genetic Predisposition, Genetic Testing, Cancer Risk Syndromes, VUS, Variant of Uncertain Significance, Pathogenic Variant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Nest Genomics
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Mar 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 research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS).
The name of the intervention used in this research study is:
Nest portal (electronic platform for patients and clinicians)
Detailed description
The goal of the electronic platform Nest is to help patients understand and manage genetic test results and recommended care and to help clinicians with access to results and recommendations, facilitating orders, and documentation. The portal has two parts, one for participants and one for clinicians.
For the first phase of the study, participants will give their feedback on the Nest portal's content and processes that will guide refinement of the portal. The Pilot phase will test the feasibility and acceptability of the intervention.
The research study procedures include a baseline survey, using the portal after receiving a brief orientation from the study team, a follow-up survey, and then a 30-minute interview.
Participants will be in this research study for up to 2 hours.
It is expected that about 40 people will take part in this research study.
The electronic platform is being developed by Nest Genomics.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nest Refinement Phase | Experimental | Behavioral: Nest Platform20 participants and clinicians will complete study procedures as outlined: * Nest portal orientation and access. * Semi-structured, 30-minute interviews. Solicited feedback on content and processes will refine the intervention for a pilot phase. |
| Nest Pilot Phase | Experimental | Behavioral: Nest Platform10 Participants and 10 clinicians will complete study procedures as outlined: * Baseline survey (participant). * Standard clinic visit. * Nest portal orientation and access (participant and clinician). * Post-visit survey (participant and clinician). * Brief, 30-minute, semi-structured interview (participant and clinician). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- YA Patients:
- Clinicians:
- YA Patients:
- Clinicians:
Key exclusion criteria (0 listed)
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 PlatformPatient- and clinician-facing portal via secure link | Behavioural | Nest Pilot Phase, Nest Refinement Phase |
Primary outcome
Proportion of Participant Utilization (Feasibility)
Time frame: 2 hours
Defined as > 70% of consenting participants who use the intervention.
Proportion of Clinician Utilization (Feasibility)
Time frame: 2 hours
Defined as > 70% of consenting clinicians who use the intervention.
Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4
Time frame: At post-visit survey, up to 2 hours
Defined as >70% of clinicians consider the intervention feasible as assessed by the post-visit survey.
Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4
Time frame: At post-visit survey, up to 30 days
Defined as > 70% of young adult participants consider the intervention successful as measured by a post-visit AIM score >4
Proportion of Clinicians with AIM Score > 4
Time frame: at post-visit survey, up to 2 hours
Defined as > 70% of clinicians consider the intervention successful as measured by a post-visit AIM score >4
2 secondary outcomes
Change in knowledge of cancer risk
Time frame: Baseline and post visit up to 2 hours
Change in Recommended screening
Time frame: Baseline and post visit up to 2 hours
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 26 Aug 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Jennifer 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 Platform in people with Genetic Predisposition to Disease and Genetic Predisposition, run by Dana-Farber Cancer Institute 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 21 inclusion and 0 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 26 Aug 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?
Proportion of Participant Utilization (Feasibility) (time frame: 2 hours). 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 26 Aug 2026.