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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05978232
Recruitment Status : Not yet recruiting
First Posted : August 7, 2023
Last Update Posted : March 12, 2024
Sponsor:
Collaborators:
Susan G. Komen Breast Cancer Foundation
Gilead Sciences
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Behavioral: NAVAH Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
Estimated Study Start Date : June 1, 2024
Estimated Primary Completion Date : July 1, 2027
Estimated Study Completion Date : July 11, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Navigator-Assisted Hypofractionation (NAVAH)

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


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of barriers to navigator access [ Time Frame: Immediately following radiotherapy treatment ]
    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.


Secondary Outcome Measures :
  1. Assess the impact of patient navigation on patient access to radiation oncology care [ Time Frame: Immediately following radiotherapy treatment ]
    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.

  2. Minority financial toxicity differences [ Time Frame: Immediately following radiotherapy treatment ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Subjects NOT of African - American ethnicity.
  • Subjects WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05978232


Contacts
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Contact: Shearwood McClelland III, MD 216-702-8700 Shearwood.mcclelland@uhhospitals.org
Contact: Shearwood McClelland III, MD drwood@post.harvard.edu

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Contact: Shearwood McClelland III, MD    216-702-8700    Shearwood.mcclelland@uhhospitals.org   
Principal Investigator: Shearwood McClelland III, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Susan G. Komen Breast Cancer Foundation
Gilead Sciences
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Shearwood McClelland III, MD University Hospitals Cleveland Medical Center Seidman Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05978232    
Other Study ID Numbers: CASE1123
First Posted: August 7, 2023    Key Record Dates
Last Update Posted: March 12, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
Radiation Therapy
Navigator-Assisted Hypofractionation
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases