Novel Outreach Methods to Increase Enrollment to Early Phase Clinical Trials

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05886764

Collaborator

Stand Up To Cancer (Other)

180

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This trial will study different outreach methods to assess impact on enrollment of underrepresented minorities (specifically African Americans) to early phase cancer clinical treatment trials. Both patients and providers (those seeing enrolled patients) will be enrolled and receive the study interventions or no intervention (control arm).

Condition or Disease	Intervention/Treatment	Phase
Cancer Malignancy Malignant Neoplasm	Other: Digital Intervention Other: Community Outreach	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Masking Description:

Patient participants will not be informed of which intervention they are assigned.

Primary Purpose:

Other

Official Title:

Randomized Trial of Recruitment Strategies for Early Phase Therapeutic Cancer Trials

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2027

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Arm 1 (No Intervention) Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods. Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.
Experimental: Arm 2 (Digital Intervention) Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.	Other: Digital Intervention Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.
Experimental: Arm 3 (Digital Intervention + Community Outreach) Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.	Other: Digital Intervention Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. Other: Community Outreach Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Arm

Intervention/Treatment

No Intervention: Arm 1 (No Intervention)

Patient participants in this arm will receive no intervention but will be approached by their providers for participation in treatment clinical trials as per the usual methods. Provider participants will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Experimental: Arm 2 (Digital Intervention)

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Other: Digital Intervention

Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Experimental: Arm 3 (Digital Intervention + Community Outreach)

Patient participants in this arm will receive digital messages (email, text, etc.) which include general educational information about clinical trials and available resources. They will also be invited to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial. Provider participants will also receive digital messages with educational materials and will receive information on available clinical trials for which their patient participant may be eligible from study staff per usual methods. Provider participants will be asked to complete surveys.

Other: Digital Intervention

Digital messages (email, text, etc.) which include general educational information about clinical trials and available resources.

Other: Community Outreach

Invitation to contact a Community Ambassador for further information and support in the decision to participate in a clinical trial.

Outcome Measures

Primary Outcome Measures

Percentage of patients that enroll to early phase cancer treatment clinical trials. [within 2 months of randomization]

Secondary Outcome Measures

Number of successfully completed outreach efforts [after 30 participants are enrolled to each of arms 2 and 3]
Percentage of patients that enroll to early phase cancer treatment clinical trials post intervention. [2 years from randomization]
Percent change in number of African Americans that enroll to cancer clinical trials [2 years after study start]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for Patient Subjects:

Aged 18 years or older
Self-described African American race (patients who self-describe as "more than one race" will be included)
Scheduled for new or consult oncology appointment at the study site
Scheduled for return outpatient oncology appointment at the study site with a biopsy or radiology encounter within 2 weeks prior to provider visit.
for prostate cancer patients: 2 or more increasing prostate specific antigen (PSA) values i the 6 months prior to visit
other patient identified by research team as potentially having a change in treatment prior to next outpatient oncology appointment at the study site

Inclusion Criteria for Provider Subjects:

oncology provider at study site scheduled to see patients meeting criteria above

Exclusion Criteria for Patient Subjects:

Estimated glomerular filtration rate (GFR) less than 30 ml/min/1.73m2 documented within last 2 months and without documented resolutions
Bilirubin greater than 3.0 ng/dl documented within last 2 months and without documented resolution
Initiated new anti-cancer therapy within last 2 months
Evaluated for possible enrollment/randomization in the last 2 months
Prior enrollment/randomization on this recruitment trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Chicago
Stand Up To Cancer

Investigators

Principal Investigator: Walter Stadler, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT05886764

Other Study ID Numbers:

IRB23-0221

First Posted:

Jun 2, 2023

Last Update Posted:

Jun 2, 2023

Last Verified:

May 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Jun 2, 2023