Expanding Genetic Access for Prostate Cancer Survivors

Официальное название

Expanding Genetic Access and Guided Education for Prostate Cancer Survivors

Обзор

The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors. The study will: Test the effectiveness of a digital guide (DG+) vs. print guide (Print+) vs. enhanced usual care (EUC) on engagement in genetic education and uptake of genetic testing. Evaluate the impact of the DG+ vs. Print+ vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes). Explore the ways (methods) that influence how participants experience the intervention. The main questions this study aims to answer are: which group - the digital guide (DG+) group, print (Print+) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education. Participants will be randomly assigned to either the digital guide (DG+) group, the print guide (Print+) group or EUC group. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the three groups to determine which is most most likely to complete genetic testing (GT) and which group engages more with genetic education.

Подробное описание

Research Design and Methods:

This study will employ a 3-arm parallel group randomized controlled trial to evaluate the efficacy of the DG+ and Print+ interventions compared to EUC among 500 prostate cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the interventions on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3).

Research Procedures:

The design for this study is a 3-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC), DG+ or Print+ in a 1:2:2 ratio - with 100 participants randomized to EUC (control) arm and 200 randomized the each of the intervention arms (DG+ and Print+).

The investigators will utilize the EHRs at our participating sites to identify prostate cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be men who have a history of prostate cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.

Вмешательства

• Поведенческое Print Genetic Education Guide
  Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
• Поведенческое Digital Guide Genetic Education Guide
  Consists of clinical letter, genetic testing kit, and access to a genetic education digital guide along with streamlined access to genetic testing for hereditary cancer risk.
• Поведенческое Enhanced Usual Care
  Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.

Первичные конечные точки

• Uptake of Germline Genetic Testing [Срок оценки: 6-Months]
• Survey Assessment of Impact of DG+ vs. Print+ vs. EUC [Срок оценки: 1-Month and 6-Month surveys]
• Survey Assessment of Mediators and Moderators of Efficacy [Срок оценки: Baseline, 1-Month and 6-Month surveys]

Вторичные конечные точки (1)

• Survey Assessment of Engagement with Genetic Education [Срок оценки: 1-Month Survey]

Критерии участия

Критерии включения

• 18-80 years of age
• At least 6-months post diagnosis with prostate cancer
• Have not had genetic testing for hereditary cancer
• Have received care at one of the participating sites in the prior five years
• Meet National Comprehensive Cancer Network criteria for germline GT
• Able to read and speak in English
• Capable of providing informed consent
• Have internet access (via smartphone, tablet or computer)
• Comfortable using a computer or mobile phone independently to access information

Критерии исключения

• Do not speak English
• Unable to access the Internet
• Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)
• Are unable to provide informed consent

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

• Georgetown University Medical Center/Lombardi Comprehensive Cancer Center — Washington D.C.
• Rutgers University/Rutgers Cancer Institute — New Brunswick

Идентификаторы

NCT: NCT07618520 · 25-08-272 · R01CA296911

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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