Cancer Clinical TrialsNCT05402033
Cancer Clinical Trials Financial Reimbursement Program
An observational study of Cancer Clinical Trials, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer Clinical Trials
- What is being tested?
- Survey / Interview Group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2022to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be recruited from among patients seen in the cancer clinics of the Harold C. Simmons Comprehensive Cancer Center, including those at UT Southwestern Medical Center, Parkland Health and Hospital System, and Children's Health. Patients with any cancer type who are informed that they are eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (generally a medical oncologist) will be offered the opportunity to determine if they are interested in and eligible for the Financial Reimbursement Program and this Research Study to evaluate the Program.
Who may be able to join
- Be enrolled in a therapeutic cancer clinical trial
- Speak English or Spanish
Who cannot join
- Not enrolled in a clinical trial
- Does not speak English or Spanish
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
David E Gerber, MD
Rebecca Renn, 214-648-7097, Rebecca.Renn@utsouthwestern.edu
About this study
Official title: Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
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.
Read the detailed description
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
- Cancer Clinical Trials
- Being tested
- Survey / Interview Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey / Interview GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Survey / Interview Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical trial enrollment retention rate measured by COST PROM
Use COST PROM to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Measured: Up to first 60 days after enrollment to a therapeutic cancer trial.
Clinical trial enrollment retention rate measured by SAHL
Use SAHL to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Measured: Up to first 60 days after enrollment to a therapeutic cancer trial.
Sociodemographic characteristics of the patients measured by COST PROM
Use COST PROM to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Measured: Up to first 60 days after enrollment to a therapeutic cancer trial.
Sociodemographic characteristics of the patients measured by SAHL
Use SAHL to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Measured: 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
The Financial Reimbursement Program will provide monthly de-identified reports to the Project team on reimbursed expenses by category, and total dollars reimbursed, stratified by study participation. Categories of financial needs/expenses are hotels, flights, parking, gas, tolls, travel companion, bus, subway, taxi/ride hailing app, car/boat service, childcare, internet access, and miscellaneous.
Measured: Up to first 60 days after enrollment to a therapeutic cancer trial.
Identify impact of participation in a Financial Reimbursement Program
Use COST PROM questionnaires to determine factors affecting patient participation decisions .
Measured: Up to first 60 days after enrollment to a therapeutic cancer trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start12 Jul 2022
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Clinical TrialsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Parkland Health and Hospital System
- Responsible party
- Principal investigator, David E Gerber, University of Texas Southwestern Medical Center
- Investigators
- David E Gerber, MD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402033
- Sponsor's protocol ID
- STU-2021-1144
- Status last verified
- Aug 2026
- First submitted
- 24 May 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Access to and Diversity in Cancer Clinical Trials Through a Financial Reimbursement and Outreach Program
- ClinicalTrials.gov ID
- NCT05402033
- Acronym / sponsor ID
- STU-2021-1144
- Conditions
- Cancer Clinical Trials
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Cancer Prevention Research Institute of Texas, Parkland Health and Hospital System
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survey / Interview Group | – | Behavioral: Survey / Interview GroupAll 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be recruited from among patients seen in the cancer clinics of the Harold C. Simmons Comprehensive Cancer Center, including those at UT Southwestern Medical Center, Parkland Health and Hospital System, and Children's Health. Patients with any cancer type who are informed that they are eligible for participation in any phase therapeutic cancer clinical trial by their treating physician (generally a medical oncologist) will be offered the opportunity to determine if they are interested in and eligible for the Financial Reimbursement Program and this Research Study to evaluate the Program.
Key inclusion criteria (2 listed)
- Be enrolled in a therapeutic cancer clinical trial
- Speak English or Spanish
Key exclusion criteria (2 listed)
- Not enrolled in a clinical trial
- Does not speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey / Interview GroupPatients 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. | Behavioural | Survey / Interview Group |
Primary outcome
Clinical trial enrollment retention rate measured by COST PROM
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use COST PROM to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Clinical trial enrollment retention rate measured by SAHL
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use SAHL to calculate the clinical trial enrollment and retention rates of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Sociodemographic characteristics of the patients measured by COST PROM
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use COST PROM to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Sociodemographic characteristics of the patients measured by SAHL
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use SAHL to determine the sociodemographic characteristics of the patients eligible for and participate in the Financial Reimbursement Program (FRP) versus those that decline to participate in the FRP.
Characteristics of patients enrolled in a Financial Reimbursement Program who do versus do not submit expense documentation for reimbursement
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
The Financial Reimbursement Program will provide monthly de-identified reports to the Project team on reimbursed expenses by category, and total dollars reimbursed, stratified by study participation. Categories of financial needs/expenses are hotels, flights, parking, gas, tolls, travel companion, bus, subway, taxi/ride hailing app, car/boat service, childcare, internet access, and miscellaneous.
Identify impact of participation in a Financial Reimbursement Program
Time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.
Use COST PROM questionnaires to determine factors affecting patient participation decisions .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Cancer Clinical Trials
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David E Gerber, MD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Clinical Trials, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Renn (214-648-7097, Rebecca.Renn@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical trial enrollment retention rate measured by COST PROM (time frame: Up to first 60 days after enrollment to a therapeutic cancer trial.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.