NAVAH for Cancer

Overseen By Shearwood McClelland III, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Disqualifiers: Non-African-American, No breast/prostate cancer

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new approach to radiation therapy, called NAVAH, which could improve outcomes for African-American patients with breast or prostate cancer. The focus is on making radiation treatment more accessible and timely, aiming to reduce current inequalities. Participants will receive assistance from a navigator to better manage their treatment and overcome barriers. Individuals with confirmed breast or prostate cancer who identify as African-American might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to more equitable cancer care.

Do I need to stop my current medications for the NAVAH for Cancer trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What prior data suggests that the NAVAH protocol is safe for cancer patients?

Research shows that Navigator-Assisted Hypofractionation (NAVAH) offers a new way to deliver radiation therapy to cancer patients. Current studies are examining how this method can improve access to radiation treatment for African-American patients. Detailed reports on side effects or safety issues specific to NAVAH have not yet emerged. However, the safety of radiation therapy, a common cancer treatment, is generally well understood.

This trial is in an early stage, focusing primarily on patient completion of the treatment. Further progress in the trial would provide more evidence about its safety. Since NAVAH involves radiation, similar safety guidelines are likely being followed. Patients should consult their doctors to understand any potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NAVAH for cancer because it seeks to enhance the patient experience during radiation therapy through a personalized approach. Unlike traditional treatments that focus solely on the medical procedures, NAVAH introduces a navigator who guides patients before, during, and after their therapy. This method aims to reduce stress and improve overall patient satisfaction by providing tailored support and addressing financial concerns. By focusing on the human aspect of cancer treatment, NAVAH could lead to better patient outcomes and a more holistic treatment process.

What evidence suggests that NAVAH is effective for cancer?

Research shows that the NAVAH program, which participants in this trial will experience, might help African-American cancer patients access radiation therapy (RT) more effectively. Studies have found that patient navigators can reduce delays and ensure patients complete RT treatments. NAVAH focuses on shortening RT for breast and prostate cancer, helping to avoid treatment delays. Previous findings suggest that patient navigation improves access to cancer care and outcomes. This approach could significantly benefit communities with limited access to quality cancer treatment. ^{1 2 6 7 8}

Who Is on the Research Team?

Shearwood McClelland III, MD

Principal Investigator

University Hospitals Cleveland Medical Center Seidman Cancer Center

Are You a Good Fit for This Trial?

This trial is specifically for African-American adults over 18 with confirmed breast or prostate cancer. Participants must be able to give informed consent and understand the study requirements. It's not open to individuals who are not of African-American ethnicity or those without a confirmed diagnosis.

Inclusion Criteria

Subjects must be of African-American race

My cancer in the breast or prostate has been confirmed by lab tests.

I am older than 18 years.

Exclusion Criteria

Subjects NOT of African-American ethnicity

I do not have confirmed breast or prostate cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy Simulation

Navigator discussion with patients prior to the start of radiation therapy simulation and administration of survey after completion of simulation

1 week

1 visit (in-person)

Radiation Therapy

Participants receive navigator-assisted hypofractionation radiation therapy

4-6 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including administration of post-treatment and financial toxicity surveys

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NAVAH

Trial Overview The NAVAH intervention is being tested to see if it can improve the completion rates of radiation therapy among African-American patients with breast or prostate cancer, addressing disparities in access to optimal cancer care.

How Is the Trial Designed?

Group I: Navigator-Assisted Hypofractionation (NAVAH) Experimental Treatment 1 Intervention

This pilot cohort study is designed as follows: 1. Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes). 2. Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes) 3. Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

University Hospitals Cleveland Medical Center

Collaborator

Trials

348

Recruited

394,000+

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Susan G. Komen Breast Cancer Foundation

Collaborator

Trials

68

Recruited

220,000+

Published Research Related to This Trial

In a study of 373 patients from 11 phase I clinical trials, ipilimumab-related grade 3/4 adverse events were more common in patients who responded to treatment, indicating a potential link between therapeutic response and toxicity.

The likelihood of experiencing severe adverse events increased with the number of additional agents used alongside ipilimumab, while longer treatment duration was associated with more low-grade toxicities but not high-grade ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic and predictive factors associated with ipilimumab-related adverse events: a retrospective analysis of 11 NCI-sponsored phase I clinical trials. Chauhan, A., Kabir, T., Wu, J., et al.[2023]

The North Central Cancer Treatment Group developed a real-time toxicity reporting system to enhance the monitoring of severe side effects in NCI-sponsored clinical trials, aiming to improve patient safety.

This system has been effective in monitoring phase II and III trials, such as the N9741 study on advanced colorectal cancer, allowing for timely modifications to ongoing clinical trials based on reported adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early detection of toxicity and adjustment of ongoing clinical trials: the history and performance of the North Central Cancer Treatment Group's real-time toxicity monitoring program. Goldberg, RM., Sargent, DJ., Morton, RF., et al.[2016]

A new tool for clinicians in inpatient oncology units has been developed to prevent adverse events and enhance patient safety, focusing specifically on cancer patients.

The tool includes a catalog of adverse events and a risk map, which helps healthcare providers implement best practices in their daily activities to improve clinical safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety in the inpatient setting through risk assessment and mitigation. Reche Navarro, MN.[2016]

In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).

The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. Zhang, Y., Zhou, S., Tao, W., et al.[2023]

The number of post-authorization safety and effectiveness studies (PASSs/PAESs) for oncology drugs has significantly increased, from just 1 study between 2006-2010 to 47 studies from 2016-2020, indicating a growing emphasis on real-world evidence for drug safety and effectiveness.

Most of these studies (64.1%) focused on safety/risk assessment, particularly regarding adverse events, while effectiveness studies primarily aimed at measuring overall survival, highlighting the need for more comparative analyses in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regulator-Requested Non-Interventional Postauthorization Safety and Effectiveness Studies for Oncology Drugs: A Systematic Review. Zhang, X., Chen, L., Bracco, OL., et al.[2022]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.5_suppl.313

Validation of navigator-assisted hypofractionation (NAVAH) ... This study is a report of the NAVAH program experience piloting a culturally sensitive survey in African-American prostate cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9518767/

Navigator-assisted hypofractionation (NAVAH) to address ... This is the first study to investigate the impact of patient navigation on reducing RT access disparities facing African-American breast cancer patients.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07014618

Navigator-Assisted Hypofractionation (NAVAH) on ... This study will use patient-completed surveys to evaluate the impact of patient navigation on access to short-course RT by using a culturally sensitive survey ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13732

Examination of post-radiation survey data from the ... The presence of patient navigation was noted to be helpful and positively contribute to cancer care, and participation in a clinical trial was ...

5. aacrjournals.org aacrjournals.org/clincancerres/article/31/12_Supplement/P5-09-15/752621/Abstract-P5-09-15-Impact-of-Patient-Navigation-on

Abstract P5-09-15: Impact of Patient Navigation on Radiation ... The Navigator-Assisted Hypofractionation (NAVAH) program is the first to formally assess the impact of patient navigation on RT in Black breast ...

6. journals.viamedica.pl journals.viamedica.pl/rpor/article/view/90034

Navigator-assisted hypofractionation (NAVAH) to address ... Navigator-assisted hypofractionation (NAVAH) to address radiation therapy access disparities facing African-Americans with breast cancer.

7. cureus.com cureus.com/articles/376042-longitudinal-impact-of-adjuvant-radiation-therapy-on-financial-toxicity-in-african-american-breast-cancer-patients-early-findings-from-the-navigator-assisted-hypofractionation-navah-program-phase-i-clinical-trial

Longitudinal Impact of Adjuvant Radiation Therapy on ... To address this gap, we conducted a prospective study as part of the ongoing Navigator-Assisted Hypofractionation (NAVAH) clinical trial. NAVAH ...

8. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.e18501

Navigator utilization rates in breast cancer patients by race ... Methods: Our study is a prospective survey-based evaluation of the impact of patient navigation on access to hypo-fractionated RT and financial ...