Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

NCT ID: NCT05759143

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2026-07-30

Brief 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)

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.

Conditions

Genetic Predisposition to Disease; Genetic Predisposition

Keywords

Genetic Predisposition to Disease; Genetic Predisposition; Genetic Testing; Cancer Risk Syndromes; VUS; Variant of Uncertain Significance; Pathogenic Variant

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Nest Refinement Phase

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.

Group Type: EXPERIMENTAL

Nest Platform

Intervention Type: BEHAVIORAL

Patient- and clinician-facing portal via secure link

Nest Pilot Phase

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).

Group Type: EXPERIMENTAL

Nest Platform

Intervention Type: BEHAVIORAL

Patient- and clinician-facing portal via secure link

Interventions

Nest Platform

Patient- and clinician-facing portal via secure link

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nest Genomics

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Mack, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Mack, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer Mack, MD

Role: CONTACT

Phone: 617-632-6818

Email: Jennifer_mack@dfci.harvard.edu

Facility Contacts

Jennifer Mack, MD

Role: primary

Other Identifiers

22-657

Identifier Type: -

Identifier Source: org_study_id