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

Primary Objective

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

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

Eligibility Criteria

Part 1 inclusion criteria:

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

Part 2 inclusion criteria:

• Female participants.
• With known deleterious/pathogenic mutation or likely pathogenic/deleterious variant in HBOC genes (BRCA1/2) or Lynch associated genes (MLH1, MSH2, MSH6, PMS2, EPCAM);
• Age criteria met by pathogenic variants as listed below:

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

Exclusion criteria

Part 1 exclusion criteria:

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

Part 2 exclusion criteria:

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