Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

NCT05759143 | Recruiting

• 1 other identifier: 22-657
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

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

Outcome Measures

Primary Outcomes (5)

• Proportion of Participant Utilization (Feasibility)

  Defined as \> 70% of consenting participants who use the intervention.

  2 hours

• Proportion of Clinician Utilization (Feasibility)

  Defined as \> 70% of consenting clinicians who use the intervention.

  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.

  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

  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

  at post-visit survey, up to 2 hours

Secondary Outcomes (2)

• Change in knowledge of cancer risk

  Baseline and post visit up to 2 hours

• Change in Recommended screening

  Baseline and post visit up to 2 hours

Study Arms (2)

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.

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).

Behavioral: Nest Platform

Interventions

Nest Platform BEHAVIORAL

Patient- and clinician-facing portal via secure link

Nest Pilot Phase; Nest Refinement Phase

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Nest Genomics: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Mack, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Mack, MD

CONTACT

617-632-6818; Jennifer_mack@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 8, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)