Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

Not Applicable

Recruiting

• Conditions: Genetic Predisposition to Disease; Genetic Predisposition
• Interventions: Behavioral: Nest Platform

• Registration Number: NCT05759143
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2023-02-24
• Study First Submitted QC: 2023-03-06
• Study First Posted: 2023-03-08
• Study Start: 2023-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-11-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nest Refinement Phase	Nest Platform	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.
Nest Pilot Phase	Nest Platform	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).

Primary Outcome Measures

Name	Time	Method
Proportion of Clinician Utilization (Feasibility)	2 hours	Defined as \> 70% of consenting clinicians who use the intervention.
Proportion of Clinicians with FIM (Feasibility of Intervention Measure) Score > 4	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 Clinicians with AIM Score > 4	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
Proportion of Participant Utilization (Feasibility)	2 hours	Defined as \> 70% of consenting participants who use the intervention.
Proportion of Participants with AIM (Acceptability of Intervention Measure) Score > 4	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

Secondary Outcome Measures

Name	Time	Method
Change in knowledge of cancer risk	Baseline and post visit up to 2 hours	Change in cancer knowledge will be assessed by participant survey at baseline and post visit.
Change in Recommended screening	Baseline and post visit up to 2 hours	Change in Recommended screening will be assessed by participant survey at baseline and post visit.

Trial Locations

Locations (1)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States