Cancer Clinical Trials Financial Reimbursement Program

Официальное название

Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Clinical trial enrollment retention rate measured by COST PROM [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]
• Clinical trial enrollment retention rate measured by SAHL [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]
• Sociodemographic characteristics of the patients measured by COST PROM [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]
• Sociodemographic characteristics of the patients measured by SAHL [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]
• Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]
• Identify impact of participation in a Financial Reimbursement Program [Срок оценки: Up to first 60 days after enrollment to a therapeutic cancer trial.]

Критерии участия

Критерии включения

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

Критерии исключения

• Not enrolled in a clinical trial
• Does not speak English or Spanish

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Экологическое

Центры проведения

США · 1 центр

• University of Texas Southwestern Medical Center — Dallas

Идентификаторы

NCT: NCT05402033 · STU-2021-1144

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗