Working Through Outreach, Navigation and Digital Enabled Referral and Recruitment Strategies (ACT WONDER²S)

Обзор

The purpose of the study is to refine, finalize, implement, and evaluate a multi-level intervention aimed at increasing enrollment of Black and Hispanic patients to National Cancer Institute (NCI)-sponsored therapeutic clinic trials at Moffitt Cancer Center.

Подробное описание

A stratified cluster randomized design will be used to assess the impact of the Advancing Clinical Trials: Working through Outreach, Navigation, and Digitally Enabled Referral and Recruitment Strategies (ACT WONDER²S) multi-level intervention on increasing referral and enrollment to NCI-sponsored therapeutic clinical trials among Black and Hispanic patients. Geospatial analytics were used to identify clusters of census tracts within the Moffitt catchment area ("priority zones") with high Black and Hispanic populations for intervention deployment. Priority zones were then matched on population characteristics and randomized to receive the intervention (n=7) or to serve as controls (n=7).

External target populations within the Catchment Area Priority Zone (CAPZ) include community residents and community physicians, while internal target populations within Moffitt Cancer Center (Moffitt) include physicians, clinical research coordinators (CRCs), and patients. The outreach and education intervention components will be facilitated by community health educators (CHEs) targeting community residents (Clinical Trial Education module and CHE support through the ACT WONDER²S Phone-line/Email), community physicians (Continuing Medical Education sessions including implicit bias training), patients at Moffitt (CHE support) and cancer center physicians/CRCs (an implicit bias training). Digitally enabled decision support tools will be developed and deployed to the CHE's (a data-empowered interactive map for outreach planning \[Precision Engagement Tool\]), community physicians (Clinical Trial Newsletters), patients at Moffitt (a clinical trial decision aid \[CHOICES DA\]), and cancer center physicians/CRCs (a recruitment dashboard to monitor clinical trial accrual rates, a clinical trial portfolio profiler, and a tool to assess the impact of clinical trial inclusion/exclusion criteria on eligibility across patient populations defined by age, race, and ethnicity \[Eligibility Criteria Calculator\]). In addition, an online portal (called the Trial Connect Portal) will be developed to connect community-based referring physicians to information about MCC trials and to facilitate their communication with cancer center physicians and CRCs. The primary outcome, enrollment to clinical trials, will be measured by comparing the percentage of Moffitt patients enrolled on NCI-supported treatment trials who are Black or Hispanic between intervention priority zones and the control priority zones. The secondary outcome, referral to Moffitt, will be measured by comparing the percentage of patients referred to Moffitt who are Black or Hispanic between the intervention priority zones and the control priority zones.

Вмешательства

• Поведенческое Continuing Medical Education Events (CME)
  An engaging 1-hour informational session focusing on topic areas such as implicit bias and emerging evidence from recent cancer clinical trials with CME credit or American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) points available.
• Поведенческое Trial Connect Portal
  A digital tool to help facilitate rapid referral of patients to clinical trial opportunities at Moffitt.
• Поведенческое Clinical Trial Newsletters
  Electronic/paper newsletters to highlight open trials at Moffitt that will be distributed by email/mail.
• Поведенческое Implicit Bias Training
  A one-hour educational module will cover information on implicit bias to support the recruitment of diverse patients.
• Поведенческое Recruitment Dashboard
  A dynamic dashboard depicting the number of patients recruited to clinical trials by gender, race, ethnicity, age, cancer type, residence in the catchment area, and other key clinical characteristics.
• Поведенческое Portfolio Profiler
  An interactive dashboard to allow cancer center physicians easily identify gaps in the current clinical trial portfolio that may be contributing to racial/ethnic disparities in trial enrollment.
• Поведенческое Eligibility Calculator
  A digital calculator that will allow for assessment of the potential impact of clinical trial eligibility criteria (e.g., comorbidities, age, lab values) that may disproportionately exclude patients who are Black and Hispanic prior to submission of clinical trial protocols to the Scientific Review Committee.
• Поведенческое Clinical Trial Education Sessions (Community Residents Only)
  An engaging 1-hour educational session delivered by a community health educator that includes basic information about clinical trials, their importance, myths, need for diversity in the trials process, and resources for finding more information about clinical trials.
• Поведенческое ACT WONDER²S Phone-line/Email (Community Residents and Moffitt Patients)
  A study team member will be available for questions via a dedicated phone-line and email for community residents and Moffitt patients with a return contact within 24-hours.
• Поведенческое New Patient Information (Moffitt Patients Only)
  Including CHOICES DA, a web-based tool to improve multiple aspects of decision-making related to participation in cancer clinical trials.

Первичные конечные точки

• Enrollment of Black and Hispanic Patients to NCI-sponsored cancer treatment clinical trials [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Referral of Black and Hispanic Patients to Moffitt Cancer Center [Срок оценки: 2 Years]
• Community residents in the intervention CAPZ [Срок оценки: 2 years]
• Community physicians in the intervention CAPZ [Срок оценки: 2 years]
• Cancer Center CRC [Срок оценки: 2 years]
• Cancer Center Physician [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Community residents: Community residents may engage with various intervention components deployed in the intervention priority zones.
• Community Physicians: may engage with various intervention components deployed in the intervention priority zones if they 1) practice medicine in one of the geographic priority zones.
• Cancer Center Physicians: may engage with various intervention components if they 1) practice medicine at Moffitt.
• Clinical Research Coordinators (CRC): may engage with various intervention components if they 1) work as a CRC at Moffitt and 2) coordinate/pre-screen patients for at least 1 therapeutic clinical trial at Moffitt.
• Cancer Center Patients: may engage with various intervention components if they have an address that maps to an intervention priority zone and 2) are newly registered patients or new existing patients (NEPs).

Критерии исключения

• Community residents, Community Physicians, Cancer Center Physicians, Clinical Research Coordinators, and Moffitt patients who do not meet the inclusion criteria.

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

Организация здравоохранения

Центры проведения

США · 1 центр

• Moffitt Cancer Center — Tampa

Идентификаторы

NCT: NCT06560398 · MCC-22140 · U01CA274971-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗