eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Официальное название

A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer

Обзор

This randomized non-inferiority study will use a 2x2 design where traditional standard-of-care pre-test (visit 1) and post-test (visit 2: disclosure) counseling delivered by a genetic counselor are replaced with a self-directed web-based eHealth intervention to provide critical data to inform optimal ways to deliver clinical genetic testing in eligible individuals, while maintaining quality of care and favorable cognitive, affective and behavioral outcomes.

Подробное описание

Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Access to genetic specialists is limited in many areas in the US, and the traditional medical delivery model of pre- and post-test counseling with a genetic professional will not support the rising indications for genetic testing. Recent data from the National Health Interview Survey found that \<20% of eligible patients with a personal or family history of breast or ovarian cancer underwent genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes.

This study aims to evaluate the effectiveness of offering web-based eHealth delivery alternatives of pre/post-test genetic counseling to provide equal or improved timely uptake of genetic services and testing, and short-term cognitive (e.g. understanding), affective (e.g. distress and uncertainty) and behavioral (risk reducing and screening behaviors and communication to providers and relatives) outcomes in patients with barriers to genetic testing as compared to the traditional two-visit delivery model with a genetic counselor.

Вмешательства

• Другое Pre-Test Intervention
  Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.
• Другое Standard of Care
  Standard of Care with a Genetic Counselor by Remote Services
• Другое Post-Test Intervention
  Secure and accessible by private code only, the web-based intervention will provide users with a the results of their clinical genetic testing results and a detailed summary of what those results mean. Additionally, an individualized summary will also be included.

Первичные конечные точки

• The KnowGene Scale [Срок оценки: Through study completion, an average of 1 year]
• Patient Reported Outcome Measurement Information System (PROMIS) [Срок оценки: Through study completion, an average of 1 year]
• Uptake of Genetic Services [Срок оценки: Through study completion, an average of 1 year]

Вторичные конечные точки (6)

• Patient Reported Outcome Measurement Information System (PROMIS) [Срок оценки: Through study completion, an average of 1 year]
• Impact of Events Scale (IES) [Срок оценки: Through study completion, an average of 1 year]
• Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) [Срок оценки: Through study completion, an average of 1 year]
• Satisfaction with genetic services [Срок оценки: Through study completion, an average of 1 year]
• Decisional Regret Scale [Срок оценки: Through study completion, an average of 1 year]
• Provider Time [Срок оценки: Through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 18 years of age or older
• Speak and understand English
• Male or Female
• No prior germline genetic testing
• Meet current National Comprehensive Cancer Network (NCCN) guidelines for germline genetic testing

Критерии исключения

-Communication difficulties such as:

• Uncorrected or uncompensated hearing and/or vision impairment
• Uncorrected or uncompensated speech defects
• Uncontrolled psychiatric/mental condition or severe physical, neurological or cognitive deficits rendering individual unable to understand study goals and tasks

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Abramson Cancer Center at the University of Pennsylvania — Philadelphia

Публикации

• Mastaglio E, Egleston B, Lee KT, Fetzer D, Brown S, Domchek SM, Fleisher L, Wen KY, Wagner L, Roberts JS, Cacioppo C, Christiansen J, Howe S, Wood EM, Weinberg M, Karpink K, Selmani E, Feng J, John S, Schweickert K, McLeod B, Bradbury AR. A Randomized Hybrid Type I Effectiveness-Implementation Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer (eREACH2): stud PMID 41332807

Идентификаторы

NCT: NCT05427240 · 13021 · 850242

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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