IGNITE-TX Phase III: (Identifying Individuals for Genetic Testing & Treatment) Intervention

Обзор

This trial aims to implement and compare an evidence- and theory-based intervention strategy (IGNITE-TX Intervention) to support probands and their ARRs in family communication, informed decision-making, and navigation to CGT with standard of care, free genetic testing/counseling, and intervention with free genetic testing/counseling.

Подробное описание

Primary Objectives:

1. Determine the impact of IGNITE-TX on the uptake of cascade genetic testing (CGT) in at-risk relatives (ARRs) at 6 months. 2. Use a mixed methods approach, guided by the NIMHD framework, to evaluate the impact of IGNITE-TX on informational, social, and emotional support outcomes within families at 6 months. 3. Employ formative and process evaluations and stakeholder engagement to guide IGNITE-TX implementation and dissemination through the RE-AIM QuEST framework.

Secondary Objective:

Analyze the correlation of CGT completion rates within families to understand the influence of familial relationships on genetic testing uptake.

Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.

Exploratory Objective:

Evaluate the effectiveness of social media as a mechanism to drive outreach, recruitment, and engagement with the IGNITE-TX intervention.

Determine the impact of the IGNITE-TX Intervention on the uptake of CGT, informational, social, and emotional support outcomes within families at 12 months.

Вмешательства

• Другое IGNITE-TX program
  Participants will complete a questionnaire
• Другое Genetic Counseling and Testing
  Participants will complete a questionnaire

Первичные конечные точки

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

Критерии участия

Критерии включения

Probands:

• 18 years of age or older
• Speaks and reads English or Spanish
• Resides in the United States
• Has a pathogenic or suspected pathogenic variant in BRCA1, BRCA2, MLH1, MSH2/EPCAM, MSH6, or PMS2\*
• Has access to the internet or phone and can send and receive email and/or text messages at a US telephone number.
• Attests to have at least one at-risk relative who meets inclusion criteria for first-degree relative

• For cancer patients who are unaware of their mutation status, we will share existing local and national genetics resources, like those provided in the usual care family letter.

At-Risk Relatives (ARR):

• 18 years of age or older
• Speaks and reads English or Spanish
• Resides in the United States
• Has a first or second degree relative who has a deleterious/suspected deleterious HBOC or LS variant present
• Has access to internet or phone and can send and receive email and/or text messages at a US telephone number

SAB:

1\. Eligible SAB will include any groups connected to HBOC or Lynch syndrome, including those that focus on underserved populations or specific ethnic communities.

Clinicians:

1\. Eligible clinicians will include gynecologic oncologists, general gynecologists, medical oncologists, and advanced practice providers who interact with individuals diagnosed with HBOC or Lynch syndrome and/or their at-risk relatives.

Критерии исключения

Probands:

• Has no eligible at-risk relatives (ARRs) or is unable/unwilling to provide their contact information
• Has negative germline genetic testing or only variant of uncertain significance
• Unwilling or unable to provide consent

At-Risk Relatives (ARR):

• Unwilling or unable to provide consent
• Reports no known HBOC or LS variant within the family
• Has already been tested for the variant identified in the proband
• Already listed as an ARR for another proband

SAB:

1\. SAB members will be excluded if they are not connected to HBOC or Lynch syndrome-related groups or if their organizations do not focus on these conditions or the communities impacted by them.

Clinicians:

1\. Clinicians will be excluded if they do not provide direct care to individuals diagnosed with HBOC or Lynch syndrome or their at-risk relatives, or if they do not practice within the specified eligible clinician roles.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• The University of Texas M. D. Anderson Cancer Center — Houston

Идентификаторы

NCT: NCT07318363 · 2025-1276 · NCI-2025-09245

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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