Nest Software for Cancer Syndromes

Overseen By Jennifer W Mack, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Nest Genomics

Disqualifiers: Age, No genetic variant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

How does the Nest Software treatment for cancer syndromes differ from other treatments?

Nest Software for Cancer Syndromes is unique because it likely involves a computational approach to analyze and interpret complex cancer data, which can help identify specific gene modules and regulatory networks. This method is different from traditional treatments as it focuses on understanding the genetic and molecular basis of cancer to potentially guide personalized therapeutic strategies. ^{1 2 3 4 5}

What is the purpose of this trial?

The goal of this clinical trial is to see if a software platform can improve cancer screening in young adults with genetic risk for cancer. The trial will also help improve the software platform (Nest). The main questions it aims to answer are: * Do Nest users know more about their cancer risks and recommended care than non-users? * Do Nest users have less psychological distress than non-users? * Do Nest users share cancer risks with family and other doctors more than non-users? * Are Nest users more likely than non-users to have up-to-date care plans? Researchers will compare Nest users to non-users to see if the Nest users are more likely to do recommended cancer screening. Participants will: * Have a genetic counseling or follow up visit * Take a post-visit survey * Intervention arm only: use the Nest Patient Navigator * Complete screening and follow-up care recommended by doctors

Research Team

Jennifer Mack, MD

Principal Investigator

Dana-Farber Cancer Institute

Huma Q Rana, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for young adults at genetic risk for cancer. Participants must be willing to use the Nest software, attend genetic counseling or follow-up visits, take surveys, and complete recommended screenings and care. Specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I can speak and read English.

Receiving care at Dana Farber Cancer Institute

I am not currently undergoing cancer treatment.

Exclusion Criteria

Not receiving care at Dana Farber Cancer Institute

I do not speak or read English.

I have not had genetic testing for cancer or my test did not find any high-risk gene changes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Pilot

Pilot Nest among young adult hereditary cancer patients and clinicians to refine implementation for feasibility and acceptability

8 weeks

1 visit (in-person) for genetic counseling or follow-up

Phase 2: Randomized Trial

Implement the Nest intervention in a randomized trial to measure its impact on patient knowledge, psychological distress, and information sharing

12 weeks

1 visit (in-person) for genetic counseling or follow-up, plus use of Nest Patient Navigator

Follow-up

Participants are monitored for outcomes such as knowledge of cancer risks, psychological distress, and information sharing

4 weeks

Treatment Details

Interventions

• Nest

Trial Overview The trial tests if the Nest software platform can improve knowledge about cancer risks, reduce psychological distress, encourage sharing of cancer information with family/doctors, and ensure up-to-date care plans compared to non-users.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Patients in the intervention arm will complete a genetic counseling or follow-up visit with a clinician using Nest Clinical Decision Support and a post visit-survey. Intervention arm patients will be given access to the Nest Patient Navigator.

Group II: Control Arm Active Control 1 Intervention

Patients in the control arm will complete a standard genetic counseling or follow-up visit and a post-visit survey.

Who Is Running the Clinical Trial?

Nest Genomics

Lead Sponsor

Trials

2

Recruited

140+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

National Human Genome Research Institute (NHGRI)

Collaborator

Trials

273

Recruited

299,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

INsPeCT: INtegrative Platform for Cancer Transcriptomics. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Systems-level network modeling of Small Cell Lung Cancer subtypes identifies master regulators and destabilizers. [2023]

3. England pubmed.ncbi.nlm.nih.gov

BCIP: a gene-centered platform for identifying potential regulatory genes in breast cancer. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Navigating Multi-Scale Cancer Systems Biology Towards Model-Driven Clinical Oncology and Its Applications in Personalized Therapeutics. [2023]

5. England pubmed.ncbi.nlm.nih.gov

COMMO: a web server for the identification and analysis of consensus gene modules across multiple methods. [2023]