Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

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)

Study Overview

• Status: Recruiting
• Conditions: Genetic Predisposition to Disease; Genetic Predisposition
• Intervention / Treatment: Behavioral: Nest Platform

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Mack, MD; Phone Number: 617-632-6818; Email: Jennifer_mack@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Dana Farber Cancer Institute
      • Contact: Jennifer Mack, MD; Phone Number: 617-632-6622; Email: JMACK@PARTNERS.ORG
      • Principal Investigator: Jennifer Mack, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Nest Platform; Patient- and clinician-facing portal via secure link
Experimental: 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).	Behavioral: Nest Platform; Patient- and clinician-facing portal via secure link

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Nest Genomics
• Investigators: Principal Investigator: Jennifer Mack, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 6, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Genetic Testing; Genetic Predisposition; Variant of Uncertain Significance; Genetic Predisposition to Disease; VUS; Cancer Risk Syndromes; Pathogenic Variant
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Susceptibility; Genetic Predisposition to Disease
• Other Study ID Numbers: 22-657

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No