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Cancer

EAQ223: Improving Diversity Participation and Enrollment in Cancer Clinical Trials, ECOG-ACRIN SUPPORT Trial

Description

Stage 1: Baseline Control Period and Approach for Localized Intervention Preparation: All participating NCORP sites will begin with a 4-month baseline “usual care” control period (i.e., pre-intervention implementation), as each site will act as its own control in our study design. Sites will be asked to identify a champion and site implementation team to take part in the intervention activities and oversee the site’s participation in SUPPORT. In Stage 1, we use a community-engaged approach, working closely with the site champion and implementation team to conduct baseline assessments and guided by findings, conduct Design Studios to support sites in preparing for intervention implementation and developing a tailored action plan.
 
SUPPORT Trial Baseline Assessments: During Stage 1, we will work closely with each NCORP site to collect baseline assessments at each site, as well as any CUSP2CT common metrics. Baseline assessments include patient surveys as well as a EHR data pull at the conclusion of the 4-month control period. Data collected during Stage 1 will serve as the data points for the site’s control condition.
 
Stage 2: NCORP Site Implementation of the SUPPORT Intervention. Stage 2 will entail NCORP sites receiving one year of the SUPPORT intervention. During this phase, champions and site implementation teams will complete the steps in the Tailored Action Plan to implement the multilevel SUPPORT intervention, consisting of the SUPPORT CT Literacy Tool: SUPPORT Trial website and SUPPORT CT Resource Navigators. All sites will receive the same intervention; there will not be differences in interventions across sites. Site champions will check in with SUPPORT Trial study staff on a monthly basis to discuss enrollment numbers to the SUPPORT Trial and challenges experienced in recruitment. The referral tracking sheet will be implemented to collect site level referrals made by treating providers. The treating provider or site-based staff will be asked to fill out the tracking sheet. The referral tracking sheet will track patients who have been identified by the site staff as eligible to participate in a clinical trial, and will include information on whether their referring provider has made a referral and whether the referred patient has consented to the clinical trial and enrolled to the referred clinical trial.
 
Typical SUPPORT Intervention Use Case: SUPPORT Navigators will: (a) implement trainings and checklist-based CT referral prompts to NCI-supported CTs for providers and site-based CT recruiters; (b) connect site-based CT staff with resources and support identifying potential CT participants; and (c) identify and address patient-level SDoH barriers to cancer CTs. The checklist of CT referral prompts includes options (based on site preference) for a printed format and/or electronic format so that providers are prompted to address CTs during the patient visit. For referring providers, the checklist will: (a) provide a link to the EA-updated list of current CTs; (b) prompt them to assess whether the patient is eligible for a trial and enter that information into the EHR; (c) if appropriate, following discussion of what to expect from treatment options in general, mention CTs as an option through which to receive treatment; (d) provide eligible patients with a pocket card with a link to the SUPPORT CT Literacy website and contact information of the SUPPORT navigator; (e) establish initial contact with the clinical research team and/or contact the SUPPORT navigator who will initiate contact. SUPPORT navigators will work with each community practice site’s team members which may include CHEs, community health workers, and patient navigators to actively address SDoH barriers to trial participation for each potential participant through resource referral at the local level, such as to NOW-POW/Aunt Bertha (free national resource) and others. SUPPORT navigators will seek out connections with treating providers to enhance identification of potential patient referrals to CTs. From the patient perspective, patients will hear from their providers that CTs may be a treatment option and have received the pocket card with the link to the SUPPORT CT Literacy website and contact information of the SUPPORT navigator. Patients will have the opportunity to visit the website to learn about CTs that will help them make an informed decision, and they will be contacted by the SUPPORT navigator who can help answer questions. The SUPPORT navigator will reach out to the participant periodically throughout the intervention period to check in with the participant and ask if they have any questions and help address any barriers to participation. The SUPPORT navigator will be in regular contact with NCORP based providers to notify providers of eligible patients as well as remind providers to complete the referral tracking sheet to collect referral data. As part of an Implementation Learning System, we anticipate sites will involve iterative improvements with regular assessment of what works and what needs to be modified with the SUPPORT intervention. All sites will receive and utilize the same SUPPORT intervention.
 
Stage 3: Sustainability & Post-Intervention Assessments. During this stage, we will conduct post-intervention follow-up assessments, along with pragmatic sustainment efforts.
 
Post-Intervention Assessments: Following the conclusion of the 12-month intervention period), trained RAs will collect effectiveness outcomes data through patient surveys at 12 months. Trial information (e.g., referral, trial entry data, trial entered, trial non-entry) will be abstracted from medical records and physicians’ clinical notes.
 
Pragmatic Sustainment: Although the 5-year study timeline precludes sufficient resources and time to study active sustainment activities, we will nonetheless, support sites’ implementation teams in developing sustainability plans informed by results from the assessments collected during Stages 2-3 that will identify any shortcomings, efficiencies, and practices that encourage sustainability. As an element of this study’s Implementation Learning System, sustainability plans will be refined through debriefings with site leaders for prioritizing strategies and opportunities to support long-term sustainability.
 
Multiple quality control strategies will be used to prevent and monitor missing data. We will program data entry and data validation controls for data collection instruments. Data analysts will assess data quality via a random case review of 10% of data collected each quarter and check to assess missingness of data; the EA data manager will attempt to resolve missing data through queries to the RAs.
 
The overall evaluation will include assessment of the clinical trials referral and accrual impacts of the SUPPORT intervention, in alignment with CUSP2CT common metrics. Data collection within each NCORP site will occur at 2 timepoints (baseline and post-intervention/12-months) and will include Patient Surveys (at baseline and 12 months), Provider Surveys (at 12 months), Stakeholder Interview (at 12 months), Patient Interviews (at 12 months), Review of CT Accrual Records, and referral tracking log of CT referral information. Each site will provide data points in both control and intervention conditions. The stakeholder interview will include healthcare providers, patients, and CT staff. Healthcare providers and patients will be randomly selected from a subset of participants who have opted in to being contacted in the future to participate in a semi-structured interview. Site champions at each site will assist with referring CT staff to participate in the stakeholder interview. The data collected from stakeholder participants will be used to inform what the needs, priorities, and barriers are to implementation of the intervention as well as strategies for communications and collaboration across stakeholders.

Inclusion Notes

For a full description of this trial, please go to the listing on www.clinicaltrials.gov 

For Medical Professionals

Inclusion Criteria: 

Eligibility Criteria for Aim 2 (Providers)

  • Participant must be a provider who specializes in medical oncology, surgery, or radiation oncology.
  • Participant must be employed at one of the participating NCORP sites.

Eligibility Criteria for Aim 2 (Patients)

  • Participant must be ≥ 18 years of age.
  • Participant must self-identify as Black and/or Latino.
  • Participant must be an oncology patient at a participating NCORP.
  • Participant must be presumed eligible (e.g. at the chart level screening) to participate in an NCI-supported clinical trial.
  • Participant must have the ability to understand and the willingness to sign a consent document.
  • Participant must be receiving care at a participating NCORP affiliated community oncology site.
  • Participant must be English or Spanish speaking.
  • Participant must have access to a landline, smartphone, computer, or tablet.

 

 

Start Date

Monday, March 2, 2026

Principal / Contact Name

Leonard Henry, MD, MBA, FACS

Phone

912-819-5704