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

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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

Tracking Information
First Submitted Date  ICMJE June 6, 2023
First Posted Date  ICMJE August 7, 2023
Last Update Posted Date March 12, 2024
Estimated Study Start Date  ICMJE June 1, 2024
Estimated Primary Completion Date July 1, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2023)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2023)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NAVAH Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
Official Title  ICMJE Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast & Prostate Cancer Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Prostate Cancer
Intervention  ICMJE Behavioral: NAVAH
Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy
Study Arms  ICMJE 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).
Intervention: Behavioral: NAVAH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2023)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 11, 2028
Estimated Primary Completion Date July 1, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shearwood McClelland III, MD 216-702-8700 Shearwood.mcclelland@uhhospitals.org
Contact: Shearwood McClelland III, MD drwood@post.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05978232
Other Study ID Numbers  ICMJE CASE1123
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Case Comprehensive Cancer Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Case Comprehensive Cancer Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Susan G. Komen Breast Cancer Foundation
  • Gilead Sciences
  • University Hospitals Cleveland Medical Center
Investigators  ICMJE
Principal Investigator: Shearwood McClelland III, MD University Hospitals Cleveland Medical Center Seidman Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP