Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. AEP strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)

Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)

Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)

Accrual

Participate in implementation discussions

Discussion

Participate in educational sessions/activities

Educational Activity

Interview

Review

Survey Administration

The Ohio State Comprehensive Cancer Center

Electra D. Paskett, PhD

Electra D Paskett, PhD

This clinical trial tests the impact of the The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) project on clinical trial referrals and enrollment in racial/ethnic minorities. Progress in cancer prevention, detection and treatment can only be made by identifying and validating new and improved methods, compounds and modalities in clinical trials. Unfortunately, participation in clinical trials is not equal across all racial and ethnic groups, limiting progress against cancer in all population groups and further widening the disparity gap. To change this picture, concerted effort needs to be directed both at the communities at risk for being left out of trials and the systems that cause the disparities at all levels involved in accrual to clinical trials. The CUSP2CT project may have the potential to increase referral and accrual of racial/ethnic minorities to prevention/control and treatment trials.

PRIMARY OBJECTIVES:

I. Conduct a baseline assessment of referral patterns and accrual of racial and ethnic minorities to clinical trials at Ohio State University Comprehensive Cancer Center (OSUCCC) by cancer disease group (breast, gastrointestinal, genitourinary, thoracic, hematologic,and others) and examine factors at the system (i.e., eligible clinical trial protocol, clinic context and culture), provider (trial discussed with patient) and patient levels (agreed or refused participation) that influence referral and accrual. (Phase I) II. Implement a multi-level intervention in a stepped wedge design in referral in 10 counties in the OSUCCC catchment area using the Accrual to Clinical Trials framework. (Phase II) III. Evaluate the impact of the intervention on referral (primary outcome) and accrual (secondary outcomes) to clinical trials. (Phase III)

OUTLINE: Counties are cluster randomized to 1 of 3 steps in Phase II of the study.

PHASE I (DEVELOPMENT): Community members, clinic staff, and providers undergo in-depth interview for intervention development on study. Researchers review baseline data on referral patterns and accrual of racial and ethnic minorities to clinical trials in each clinic site. Providers, clinical staff, and research team participate in implementation discussion. Accrual enhancement program (AEP) strategies developed and initiated in one OSUCCC/James clinic. Providers and community members participate in educational sessions on study. (Year 1)

PHASE II (IMPLEMENTATION): Participants participate in the AEP in the remaining clinics at OSUCCC/James and community clinics on study. Community members and providers participate in culturally tailored educational activities. Providers, patients, and community members participate in interviews to explore current barriers to referral and participation on study. (Years 2-4)

PHASE III (EVALUATION): Providers, clinic staff, patients, and community members participate in interviews to explore current barriers to referral and participation. (Year 5)

Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial

The Ohio State University Connecting Underrepresented Populations to Clinical Trials (CUSP2CT) Project

Calculate change in clinical trial referrals

Calculate the change in clinical trial minority enrollments

Calculate the number of clinics who adapt program

Recent regression models used for stepped wedge designs that flexibly model the effect curve of the intervention over time. Effect estimates and 95% confidence intervals will accompany significance tests, and graphical displays of the final effect curve will aid in understanding the efficacy of the intervention.

National Cancer Institute (NCI)

Ohio State University Comprehensive Cancer Center

Principal Investigator

Kiosk will consist of a patient facilitator and a computer with access to general information about clinical trials and information specific to active clinical trials at the facility. Patients will be made aware of the kiosk via a large banner visible in the clinic above the kiosk.

Clinical Trial Kiosk

The proposed study will include patients with non-haematologic cancer. Eligible patients will be invited to consent for participation in our study using standard demographic data collection forms and patient satisfaction questionnaires.

Cancer patients interested in learning more about clinical trials would be invited to go to the kiosk. A summer student approved and hired according to London Health Sciences Centre LHSC/Lawson criteria will be available from 0900-1630 daily for general assistance. If the student is overwhelmed by questions or numbers of patients, the Research Navigator or designate would be called to assist.

An information kiosk will be placed at the patient library on the ground floor of the LRCP. This kiosk will be outfitted with a computer and signage briefly outlining the title and purpose of the kiosk. Cancer patients interested in learning more about clinical trials would be invited to participate in our study by signing a consent form allowing the Research Navigator to contact them if they expressed interest in knowing more about a clinical trial.

The proposed study will include patients with non-haematologic cancer. Eligible patients will be invited to consent for participation in our study using standard demographic data collection forms and patient satisfaction questionnaires.

Cancer disease site teams (DSTs) were asked to prioritize trials that open from May 1 to Sept.30, 2018 and likely to accrue three patients over six months for major accruing tumour sites (lung, breast, GI, GU, melanoma and symptom control/supportive care/multi-site such as oligometastatic) and one patient over six months for other sites.

Patients are made aware of the kiosk via advertising in the facility including a card given at registration each day outlining the existence, location and purpose of the kiosk. The location will be marked by visual cues (banner and balloons). Cancer patients interested in learning more about clinical trials would be invited to go to the kiosk. A summer student approved and hired according to LHSC/Lawson criteria will be available from 0900-1630 daily from July 3-Aug 31 for general assistance. If the student is overwhelmed by questions or numbers of patients, the Research Navigator or designate would be called to assist.

An information kiosk will be placed at the patient library on the ground floor of the LRCP. This kiosk will be outfitted with a computer and signage briefly outlining the title and purpose of the kiosk. Cancer patients interested in learning more about clinical trials would be invited to participate in our study by signing a consent form allowing the Research Navigator to contact them if they expressed interest in knowing more about a clinical trial. They would still be able to read a lay online or printed paper document giving them background information on clinical trials (i.e. what is a clinical trial?) whether they consented or not. To save on resources, the pilot will utilize general information available to the public from the Stanford Cancer Institute Clinical Trials website at http://med.stanford.edu/cancer/trials.html and a Canadian website http://itstartswithme.ca/why-participate/ . Information specific to clinical trials at London Regional Cancer Program (LRCP) will be made available by linking to an internal resource. Patients will be asked if they would be interested in seeing brief summaries of selected clinical trials currently available at the LRCP. They would then be asked to review a list of possible trials they may be eligible for based on their cancer diagnosis. Patients will have the option to click on each of the applicable trials to obtain more information including: trial title, NCT number, a lay description, why the study is important, principal investigator name, and a short list of eligibility criteria. Additionally, patients have the option to send any trial information they might be interested in to their home their email address or obtain a paper copy of the information.

Finally, at the kiosk patients who signed a consent, would have the option to submit electronically their first/last name and DOB in order to grant permission for a member of the Clinical Research Unit (CRU) staff, the Research Navigator, to review their request for further clinical trial information, contact them with potential options and contact their oncologist(s) to discuss their potential enrollment in a specific trial. This consent, patient name and PIN numbers would then be emailed to the CRU. Alternatively, they could fill this out on a paper form that would be dropped into a secure mailbox at the kiosk that would be collected at the end of each day. The information would be logged on a secure electronic database by HM and the paper documents except for consent destroyed (or kept in a secure area). The Research Navigator would contact the patient by phone to provide further details of the trial(s) of interest and to determine eligibility. If the patient is interested and eligible, an indication of the clinical trial of interest would be added to the scheduling list beside the patient's name.

After a two week run in phase, accrual, logistical and communications issues will be reviewed to ensure the kiosk project is functioning efficiently and to review patient satisfaction.

Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study

Present at meetings and publish in peer reviewed journal

Demographic correlations of patients seeking additional information. This will include age, sex, urban/rural status obtained from electronic health records. Patients will also be asked to voluntarily provide information on income, occupational status and whether they had previously been approached about a cancer clinical trial.

Our primary objective is to quantify the clinical trial accrual rates in a subset of trials that are selected as priority trials and are open both two months before and three months after implementation of the clinical trial information kiosk. Accrual rates before and after implementation will be compared.

1. To determine the proportion of patients who accessed the kiosk provided information so that they could be contacted by the Research Navigator.

2. To determine what proportion of patients who were contacted the research navigator were eligible to participate in a clinical trial.

To determine what proportion of patients eligible for a clinical trial actually participated.

To evaluate patient satisfaction with the clinical trial information kiosk using a Likert scale.

To determine the number of individuals who interacted with the information kiosk compared to total number of cancer patients seen in clinic when the kiosk is open.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outreach Project to Connect Underrepresented Populations to Clinical Trials at Ohio State University, CUSP2CT Project Trial	NCT06314672	Hematopoietic a... Malignant Solid...	Accrual Discussion Educational Act... Interview Review Survey Administ...	-	Ohio State University Comprehensive Cancer Center
Can Electronic Information Kiosks Enhance Patient Accrual for Cancer Clinical Trials? A Pilot and Feasibility Study	NCT03747276	Malignant Neopl...	Clinical Trial ...	18 Years -	Lawson Health Research Institute

Spots Global Cancer Trial Database for accrual

Every month we try and update this database with for accrual cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for accrual

Every month we try and update this database with for accrual cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for accrual cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.