ACT-GEN (Adherence And Care Tracking In GENetic Cancer Syndromes)

To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.

Study Overview

• Status: Not yet recruiting
• Conditions: ACT-GEN; Genetic Cancer Syndromes
• Intervention / Treatment: Other: Interviews; Other: Standard of care

Detailed Description

Primary Objective

1. The primary objective of this study is to assess feasibility of the intervention by achieving benchmarks, including:

1. Design and development of the iPhone/Android application;
2. Collation of a network of providers with expertise in BRCA1/2 and Lynch Syndrome by state/region for enrolled participants;
3. Enrollment of participants within a 6-month period;
4. Engagement of participants via standardized digital user analytics (number of downloads, active users, monthly active users, conversion rate); and
5. Completion of baseline and interval surveys

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jose Rauh-Hain, MD; Phone Number: 713-794-1759; Email: jarauh@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center
      • Contact: Jose Rauh-Hain, MD; Phone Number: 713-794-1759; Email: jarauh@mdanderson.org
      • Principal Investigator: Jose Rauh-Hain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Eligibility Criteria

Part 1 inclusion criteria:

1. Female participants.
2. 18 years of age or older;
3. With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
4. Speaks and reads English or Spanish; and
5. Has access to a smartphone with operating system compatible with iOS/Android applications.

Part 2 inclusion criteria:

1. Female participants.
2. With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);

3. Age criteria met by pathogenic variants as listed below:

   1. BRCA1 pathogenic variant or deleterious mutation: ≥ 35 years old
   2. BRCA2 pathogenic variant or deleterious mutation: ≥ 40 years old
   3. MLH1 pathogenic variant or deleterious mutation: ≥ 20 years old
   4. MSH2 pathogenic variant or deleterious mutation: ≥ 20 years old
   5. MSH6 pathogenic variant or deleterious mutation: ≥ 30 years old
   6. PMS2 pathogenic variant or deleterious mutation: ≥ 30 years old
   7. EPCAM pathogenic variant or deleterious mutation: ≥ 20 years old
4. Speaks and reads English or Spanish.
5. Has access to a smartphone with operating system compatible with iOS/Android applications; and
6. Has not previously undergone bilateral salpingo-oophorectomy.

Exclusion Criteria

Part 1 exclusion criteria:

1. Unwilling or unable to provide consent; or
2. Does not have access to a smartphone or is unable to access the application on their phone;

Part 2 exclusion criteria:

1. Unwilling or unable to provide consent;
2. No deleterious or pathogenic variant in HBOC genes (BRCA1/2), or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, or EPCAM);
3. Does not have access to a smartphone or is unable to access the application on their phone.
4. Actively being treated for malignancy with cytotoxic therapy.
5. History of gynecologic or breast malignancy; or
6. Has previously undergone bilateral salpingo-oophorectomy (for BRCA1/2).
7. Participated in Part 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Design and development; This part of the study is a qualitative study that will include Qualitative Interviews with participants to help design a patient-centered digital application.	Other: Interviews; Up to three interviews may be conducted per participant, and they may take place remotely via a secure videoconferencing service to limit disruptions to the participants schedule as well as any financial burden associated with travel.
Experimental: Part 2: Feasibility study with two-arm randomization; Patients will be randomized in a 1:1 ratio through REDCap to one of the two study arms described below.	Other: Standard of care; Standard of Care, no efforts will be made toward any of the study objectives

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and adverse events (AEs).	Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	Through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Jose Rauh-Hain, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Quality Indicators, Health Care; Interviews as Topic; Standard of Care
• Other Study ID Numbers: 2026-0038; NCI-2026-03287 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

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