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

Обзор

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

Подробное описание

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

Вмешательства

• Другое Standard of care
  Standard of Care, no efforts will be made toward any of the study objectives
• Другое 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.

Первичные конечные точки

• Safety and adverse events (AEs). [Срок оценки: Through study completion; an average of 1 year]

Критерии участия

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• MD Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07565467 · 2026-0038 · NCI-2026-03287

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗