Increasing Access to Definitive Treatment for Prostate Cancer

NCT06034431 | Not Yet Recruiting

• 1 other identifier: 23-285
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators will address the overarching challenge of advancing health equity and reducing disparities in prostate cancer by informing efforts to reduce travel burden in prostate cancer (PCa) treatment access among Black men.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Number of participants receiving definitive treatment within 90 days of diagnosis

  Surgery or radiation within 90 days of diagnosis, among men with prostate cancer diagnosed at localized or regional-intermediate stage. Investigators will identify patients with localized or regional intermediate- or high-risk PCa receiving definitive therapy (surgery and radiation to the prostate) within 90 days of diagnosis. Although there are no existing guidelines that recommend specific thresholds of timely receipt of treatment, initiating treatment within 90 days of diagnosis is considered enough time to account for logistics and the possible delay caused by seeking a second opinion. Registries only record the first treatment, so Investigators will rely on these measures to assess differences in travel burden to different locations, depending on the type of treatment. Investigators will estimate delays in treatment initiation by calculating the days between diagnosis and treatment initiation

  Within 90 days of diagnosis

Secondary Outcomes (2)

• Rate of Missed appointments

  Within 18 months of surgery date

• Exit Interview

  30 months after surgery date

Study Arms (1)

Ride Share Participants

EXPERIMENTAL

Investigators will recruit Black men with intermediate or high-risk PC who are seeking definitive treatment at Mass General Brigham Prostate Cancer Outreach Clinic, as Black men are more likely to report travel burden when accessing care and, therefore, most likely to benefit from ridesharing services. Investigators will implement a pre/post-evaluation design with matched historical controls to estimate the impact of rideshares on reducing missed appointments. Historical controls will be sampled from the pre-intervention period of April 2022 to September 2024 and the post-intervention period between October 2024 and November 2025, where October 2024 represents the initiation of the intervention. Participants who identify as Black, reside in a census tract in Massachusetts, and have been recognized as having a high travel burden based on results from Aim 1 will be eligible to receive the rideshare intervention

Other: Ride Share

Interventions

Ride Share OTHER

The Investigators' proposed study addresses the Prostate Cancer Research Program overarching challenge of Advancing Health Equity and Reducing Disparities in PCa by examining and addressing travel burden to PCa treatment centers. Investigators will focus on Black men (including those of Caribbean descent), a high-risk population experiencing poorer health outcomes for unjust and preventable reasons. This research will inform efforts to reduce travel burden in the healthcare acquisition process and improve the timeliness of treatment in Black men with PCa in Massachusetts and other states. This project will improve the quality of life and enhance outcomes and overall health and wellness for this group. Investigators will use findings from this pilot study to obtain future funding for a multicenter randomized clinical trial that will estimate the effect of equity - oriented programs that remove transportation barriers to treatment and reduce Black-White disparities in PCa outcomes

Ride Share Participants

Eligibility Criteria

• Age: 22 Years+
• Gender Eligibility Details: This study deals with prostate cancer which requires male patients.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Black man
• Intermediate-or high-risk prostate cancer
• Seeking prostate cancer definitive treatment (surgery or radiation) at the Mass General Brigham Prostate Cancer Outreach Clinic
• Reside in a census tract in Massachusetts recognized as having a high travel burden based on results of Aim1 of the Project OR identifies as having difficulties or challenges when it comes to transportation, particularly in relation to getting to and from medical appointments

You may not qualify if:

• None

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• United States Department of Defense: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Quoc-Dien Trinh, MD,MBA

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wesley Chung

CONTACT

617-525-8710; wchung7@bwh.havard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

US (1)