Addressing Genomic Disparities in Cancer Survivors

Обзор

The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will: 1. Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing. 2. Evaluate the impact of the chatbot vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes). 3. Explore the ways (methods) that influence how participants experience the intervention. 4. Explore the feasibility of incorporating a Family Sharing Portal (FSP) for participants who receive a positive test result, to facilitate family communication of these test results and genetic testing of first-degree biological relatives after they have received genetic education by the RA. The main questions this study aims to answer are which group - the chatbot (RA) 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 chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.

Подробное описание

Research Design and Methods:

This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the RA intervention compared to EUC among 428 Black 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 RA intervention on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3). In response to patient identified needs, we will also explore the feasibility of incorporating a Family Sharing Portal (FSP). All participants who receive a positive test result will be input into the FSP (Aim 4).

Research Procedures:

The design for this study is a 2-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) or RA. Randomization will be balanced in a 1:1 ratio - with 214 participants randomized to each arm. Because this study is designed to address the disparity of low genetic testing utilization in Black cancer patients, all study participants will be Black and approximately 10% will be Hispanic.

The investigators will utilize the EHRs at our participating sites to identify cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC), MedStar Washington Cancer Institute (MWCI) and MedStar Franklin Square Medical Center 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 women and men who self-identify as Black or African American, have a history of breast, ovarian, uterine, colorectal, prostate, or pancreatic 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 Relational agent (RA) / Chatbot
  Consists of clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors.
• Поведенческое Enhanced Usual Care (EUC)
  Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors.

Первичные конечные точки

• Uptake of Germline Genetic Testing [Срок оценки: 6-months]
• Survey Assessment of Impact of RA vs. EUC [Срок оценки: 1-month and 6-month survey]
• 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
• Self-identify as Black or African American
• At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
• 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: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 2 центра

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

Публикации

• An J, Huq M, Speiser E, Grumet S, Peshkin BN, Heidt E, Adams-Campbell L, Grisham C, Tundealao S, Yesha R, Toppmeyer D, Isaacs C, Sorgen L, Tan N, Hooda-Nehra A, Nix MA, Reed DJ, Staton J, Schwartz MD, Kinney AY. Expanding access to cancer genetic care for cancer survivors: Rationale and design for a randomized controlled trial of a chatbot-based genetic education and testing. Contemp Clin Trials. PMID 41554333

Идентификаторы

NCT: NCT06073626 · Pro2022001513 · R01CA277599

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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