Implementation of eHealth Delivery Alternatives for Cancer Genetic Testing for Hereditary Cancer (eREACH3)

Обзор

The purpose of the study is to understand patient interest in telehealth and digital tools for pre-test genetic education and/or disclosure of genetic test results. Participants will receive telehealth genetic counseling in the home and may be offered various digital tools to help with the counseling and testing process. These are optional and participants can still speak with a genetic counselor if they wish.

Подробное описание

The goal of the eREACH3 Study is to evaluate the implementation of these tools into remote genetic services, evaluating uptake and use of digital tools and outcomes in representative clinical populations. The initial protocol will include two genetic counseling visits, providing comparison outcomes. Future amendments will be provided as digital tools are ready for implementation.

Specific Aim 1: (Reach) Evaluate the uptake, use and acceptability of digital delivery alternatives in remote genetic services provided as alternatives to the traditional two-visit model with a genetic counselor.

Specific Aim 2: (Effectiveness) Evaluate short-term and 6 month patient reported cognitive, affective and behavioral outcomes (2a) with remote genetic services and digital alternatives in representative clinical populations and moderators of outcomes (2b).

Specific Aim 3: (Implementation) Evaluate provider time associated with implementation of remote telehealth services and digital delivery alternatives and barriers and facilitators to future clinical implementation.

Первичные конечные точки

• Uptake of Visit 1 [Срок оценки: Through 6 months]
• Uptake of Digital Visit 1 [Срок оценки: Through 6 months]
• Uptake of genetic testing [Срок оценки: Through 6 months]

Вторичные конечные точки (6)

• The KnowGene Scale [Срок оценки: Through study completion, an average of 6 months]
• Test result recall [Срок оценки: Through study completion, an average of 6 months]
• Impact of Events Scale (IES) [Срок оценки: Through study completion, an average of 6 months]
• Satisfaction with genetic services [Срок оценки: Through study completion, an average of 6 months]
• Multi-dimensional Impact of Cancer Risk Assessment Questionnaire (MICRA) [Срок оценки: Through study completion, an average of 6 months]
• Decisional Regret Scale [Срок оценки: Through study completion, an average of 6 months]

Критерии участия

Критерии включения

• 18 years of age or older
• Speak and understand English
• Meet current National Comprehensive Cancer Network (NCCN) or other national guidelines for germline genetic testing or are interested in genetic counseling based on personal or family history of cancer. Patients with prior genetic testing are eligible if they meet criteria for updated testing, or if post-test genetic counseling services are requested.

Критерии исключения

• Communication difficulties such as:
• Uncorrected or uncompensated hearing and/or vision impairment. Patients who can successfully use clinical assistance devices are not excluded.
• Uncorrected or uncompensated speech defects. Patients who can successfully use clinical assistance devices are not excluded.
• 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

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Abramson Cancer Center at the University of Pennsylvania — Philadelphia

Идентификаторы

NCT: NCT07471958 · UPCC 12025 · IRB#858825

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗