Viewing Study NCT00400699



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Last Modification Date: 2024-10-26 @ 9:29 AM
Study NCT ID: NCT00400699
Status: COMPLETED
Last Update Posted: 2014-01-31
First Post: 2006-11-16

Brief Title: Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: UPMC McKeesportROCOG Radiation Oncology Minorities Outreach Program
Status: COMPLETED
Status Verified Date: 2014-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE An outreach program may help minority or low-income cancer patients overcome problems that keep them from receiving quality care

PURPOSE This clinical trial is studying how well a radiation therapy outreach program works in minority or low-income patients with newly diagnosed cancer
Detailed Description: OBJECTIVES

Develop over five years and implement a shared infrastructure that will permit participating community cancer centers to participate in radiation oncology clinical research and dramatically increase their rate of trial accrual above historical patterns
Increase access to radiation oncology services and clinical trials for underserved minority andor low-income patients in the target areas through community and professional education and outreach activities
Assess and ensure the quality of radiation oncology services at participating facilities through the use of a new integrated radiation oncology outcomes database and a quality assurance program benchmarking daily practice patterns to clinical practice protocol
Compare treatment approaches and outcomes for cervical colorectal lung prostate breast and head and neck cancers across racial and socioeconomic status groups
Conduct community intervention pilot programs that advance the understanding of factors that lead to health disparities
Develop and implement clinical treatment studies that attempt to reduce or eliminate health disparities through novel treatment approaches
Develop and refine a model program that can be sustained by the community treatment facilities long after study completion and that the National Cancer Institute or other similarly motivated funders can replicate within other regions

OUTLINE This is a multicenter study

Patients are enrolled in the Patient Navigator program an initiative to promote equal access and quality of cancer care Patients undergo an interview with the Patient Navigator who is an oncology health professional over approximately 1 hour to identify specific needs in terms of receiving cancer care The interview serves as a basis for developing a plan to assist patients through treatment and follow up The Patient Navigator meets the patient in person or over the phone at various times during treatment to help the patient overcome barriers to completion of cancer therapy The Patient Navigator then provides yearly follow up to facilitate continued medical follow up Patients complete surveys before and after program participation

Patients are followed periodically to determine their current status in cancer therapy

TELESYNERGY a portable live-time interactive telemedicine system is utilized in developing the necessary infrastructure and professional education in the community It is used for sharing information and approaches for case presentation treatment planning conferences and other specialized presentations by invited speakers and expert panels Activities using the TELESYNERGY system are videotaped to create a library of topic-centered presentations that can be shared with the larger community Components and summaries are placed on an Internet site to encourage communication with the larger oncology community

PROJECTED ACCRUAL A total of 3150 patients will be accrued for this study

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CDR0000513067 REGISTRY PDQ Physician Data Query None