Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

Genetic Predisposition Clinical Trial

Official title:

Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05759143
• Other study ID #: 22-657
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: March 30, 2026

Study information

• Verified date: November 2023
• Source: Dana-Farber Cancer Institute
• Contact: Jennifer Mack, MD
• Phone: 617-632-6818
• Email: Jennifer_mack[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

The name of the intervention used in this research study is:

Nest portal (electronic platform for patients and clinicians)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria AIM 1:

• 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.

• 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.

Inclusion Criteria AIM 2:

• 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.

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease

Intervention

Behavioral:
• Nest Platform
Patient- and clinician-facing portal via secure link

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Nest Genomics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participant Utilization (Feasibility)	Defined as > 70% of consenting participants who use the intervention.	2 hours
Primary	Proportion of Clinician Utilization (Feasibility)	Defined as > 70% of consenting clinicians who use the intervention.	2 hours
Primary	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.	At post-visit survey, up to 2 hours
Primary	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	At post-visit survey, up to 30 days
Primary	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	at post-visit survey, up to 2 hours
Secondary	Change in knowledge of cancer risk	Change in cancer knowledge will be assessed by participant survey at baseline and post visit.	Baseline and post visit up to 2 hours
Secondary	Change in Recommended screening	Change in Recommended screening will be assessed by participant survey at baseline and post visit.	Baseline and post visit up to 2 hours