ACT-GEN, Genetic Cancer Syndromes
Conditions
Brief summary
To help people with high-risk cancer variants to follow cancer surveillance guidelines and lower their risk of developing the disease.
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
Interventions
OTHERStandard of care
Standard of Care, no efforts will be made toward any of the study objectives
OTHERInterviews
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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and adverse events (AEs). | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTJose Rauh-Hain, MD
PRINCIPAL_INVESTIGATORJose Rauh-Hain, MD
M.D. Anderson Cancer Center
Outcome results
None listed