Cancer Clinical Trials Financial Reimbursement Program

NCT ID: NCT05402033

Last Updated: 2025-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-12

Study Completion Date

2027-06-01

Brief Summary

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To implement a Financial Reimbursement and Outreach Program at clinical sites within the Harold C. Simmons Comprehensive Cancer Center; and evaluate the impact of the program on clinical trial enrollment and demographics, as well as facilitators of and barriers to program participation.

Detailed Description

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The overall purpose of this study is to determine the impact of a Financial Reimbursement Program on recruitment and retention to therapeutic cancer clinical trials, including evaluating program facilitators and barriers, as well as patient acceptability and adoption of the program.

The procedures involved for this study are surveys and interviews. Subjects will complete two surveys which are expected to take about 10-15 minutes. Some of the subjects will also be invited to complete follow-up interviews after 21 days and between 30 and 90 days. The surveys and interviews are for research purposes only.

Statistical analysis: Two-sample t-tests and chi-square tests to determine the association between socio-demographic variables, financial toxicity, health literacy, and Financial Reimbursement Program participation.

Conditions

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Cancer Clinical Trials

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Survey / Interview Group

All patients (or parent / caregiver, if relevant) who provide informed consent will be asked to complete baseline assessments utilizing validated questionnaires administered through the phone or video call. The clinical research coordinator will input responses into REDCap. Alternatively, patients may request assessments be sent through secure email.

Baseline assessment consisting of sociodemographic items and study eligibility questions (call #1)

In addition, each patient will complete the Comprehensive Score for financial Toxicity Patient Reported Outcome Measure (COST PROM) and Short Assessment of Health Literacy (SAHL) survey measures.

Survey / Interview Group

Intervention Type BEHAVIORAL

Patients with any cancer type who are informed that they may be eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (typically a clinical oncologist) will be provided information about the Financial Reimbursement Program. Patients who enroll to therapeutic cancer clinical trial will be eligible for the reimbursement program and offered an opportunity to participate in this study.

Interventions

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Survey / Interview Group

Patients with any cancer type who are informed that they may be eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (typically a clinical oncologist) will be provided information about the Financial Reimbursement Program. Patients who enroll to therapeutic cancer clinical trial will be eligible for the reimbursement program and offered an opportunity to participate in this study.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Be enrolled in a therapeutic cancer clinical trial
* Speak English or Spanish

Exclusion Criteria

* Not enrolled in a clinical trial
* Does not speak English or Spanish
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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David E Gerber

Professor, Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David E Gerber, MD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rebecca Renn

Role: CONTACT

214-648-7097

Facility Contacts

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David E Gerber, MD

Role: primary

Rebecca Renn

Role: backup

214-648-7097

Other Identifiers

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STU-2021-1144

Identifier Type: -

Identifier Source: org_study_id

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