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Breast CancerNCT05978232

NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

A study testing NAVAH in people with Breast Cancer and Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

African-Americans have disparately limited access to optimal cancer care. They have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Prostate Cancer
What is being tested?
NAVAH
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Jul 2023to 3 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have histologically or cytologically confirmed Breast or Prostate Cancer.
  • Subjects must be Age >18 years. This study requires informed consent by the subject; as children are not able to perform this without parental approval, subjects < age 18 are excluded from this study.
  • Subjects must be of African - American race.
  • Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Subjects NOT of African - American ethnicity.
  • Subjects WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106

Other trials in United States

About this study

Official title: Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients

African-Americans have disparately limited access to optimal cancer care. They have the highest overall cancer death rate and shortest survival time of any racial or ethnic group in the United States. Elucidation of disparities in access to cancer care are important since previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group (RTOG) prospective randomized trials is granted, race does not independently affect outcomes, a finding similar to work conducted in Level I evidence-proven optimal management of curable neurologic conditions. Breast cancer is the most common cancer in African-American women and Prostate cancer is the most common cancer in African-American men. African-American breast \& prostate cancer participants are less likely to receive standard-of-care radiation therapy.

Previous work has identified that compared to Caucasian women with breast cancer, African-American women are 48% more likely to have RT omission during treatment, 167% less likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to complete RT, and significantly more likely to experience RT treatment delays. Shorter course radiation therapy may reduce disparities in radiation therapy care facing African-American breast cancer participants.

Being tested
NAVAH
Keywords
Radiation Therapy, Navigator-Assisted Hypofractionation
Medical subject headings
Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NAVAHBehavioural

    Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy

Study groups in NCT05978232
Study groupRoleWhat they receive
Navigator-Assisted Hypofractionation (NAVAH)ExperimentalThis 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).
Receives: Behavioral: NAVAH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of barriers to navigator access

    Survey-based methods will be used to assess barriers facing under-represented minority cancer patient access to patient navigation. This study will use a patient-completed, culturally sensitive survey adapted from "Walking Forward," a patient navigator program providing culturally appropriate community education on cancer, screening and treatment, to include barriers to specific RT regimens, and concerns regarding transportation.

    Measured: Immediately following radiotherapy treatment

Secondary outcomes (2)

  1. Assess the impact of patient navigation on patient access to radiation oncology care

    Qualitative mechanisms will be used to assess the impact of patient navigation on patient access to radiation oncology care and consequently utilization of standard of care modalities. 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 adapted from "Walking Forward", a patient navigator program providing culturally appropriate community education on cancer, screening and treatmen. The feedback provided by patients on the impact of patient navigation will be compared- before and after RT, and will also be compared against feedback from patients who did not received patient navigation.

    Measured: Immediately following radiotherapy treatment

  2. Minority financial toxicity differences

    This study will use patient-completed surveys to evaluate the impact of financial hardship in African-American breast cancer patients. Patient scores from an evidence-based tool, "The COmprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)" will be used to compare financial hardship in each group of patients with early-stage breast cancer who have received a lumpectomy. Surveys will investigate differences in financial toxicity survery scores experienced by underrepresented minorities receiving conventional versus short-course RT.

    Measured: Immediately following radiotherapy treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start1 Jul 2023
  3. Primary completion3 Nov 2025
  4. Study completion3 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05978232
Sponsor's protocol ID
CASE1123
Status last verified
Nov 2025
First submitted
6 Jun 2023
Last updated
5 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • McClelland S 3rd, Burnette U, Onyewadume L, Smith TK, Speers CW. Impact of Patient Navigation on Radiation Therapy Completion in Black Breast Cancer Patients: Early Phase I Trial Results From the Navigator-Assisted Hypofractionation (NAVAH) Program. Am J Clin Oncol. 2026 Mar 1;49(3):125-126. doi: 10.1097/COC.0000000000001257. Epub 2025 Oct 15.

    PubMed 41091946

  • Posani S, Burnette UJ, McClelland S 3rd. Quantification of Postdiagnosis Cancer Patient Navigation. Am J Clin Oncol. 2025 Dec 1;48(12):610-613. doi: 10.1097/COC.0000000000001225. Epub 2025 Jun 17.

    PubMed 40525892

  • Davis KJ, Burnette UJ, Sun Y, Stephens MJ, Onyewadume L, McClelland S 3rd. Medical Racism and Physician Trust Impressions of African-American Breast Cancer Patients Enrolled on the Navigator-Assisted Hypofractionation (NAVAH) Phase I Clinical Trial. Am J Clin Oncol. 2025 Jul 1;48(7):339-341. doi: 10.1097/COC.0000000000001183. Epub 2025 Mar 3.

    PubMed 40025854

Questions about this trial

What is this clinical trial studying?

A study testing NAVAH in people with Breast Cancer and Prostate Cancer, run by Case Comprehensive Cancer 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 4 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: finished, as of the sponsor's last update on 5 Nov 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of barriers to navigator access (time frame: Immediately following radiotherapy treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05978232, which also lists 3 linked publications.

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 5 Nov 2025.

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