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Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer

This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), April 2008

Sponsors and Collaborators: UPMC Cancer Center at UPMC McKeesport
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00400699
  Purpose

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.


Condition Intervention
Psychosocial Effects/Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: counseling
Procedure: psychosocial assessment and care
Procedure: study of socioeconomic and demographic variables

MedlinePlus related topics:   Cancer   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Open Label
Official Title:   UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical stage at time of presentation (indicator of early access to system) [ Designated as safety issue: No ]
  • Date and nature of post-diagnosis surgery or biopsy [ Designated as safety issue: No ]
  • Proportion of patients compliant with treatment plan [ Designated as safety issue: No ]
  • Total radiation dosage per patient (curative and palliative endpoints) [ Designated as safety issue: No ]
  • Supportive services provided to patients [ Designated as safety issue: No ]
  • Rate of treatment completion [ Designated as safety issue: No ]
  • Accrual for clinical research protocols [ Designated as safety issue: No ]
  • Retention in clinical research protocols [ Designated as safety issue: No ]
  • Barriers to treatment (perceived and real) [ Designated as safety issue: No ]

Estimated Enrollment:   3150
Study Start Date:   October 2004

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 and/or 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 3,150 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS:

  • Newly diagnosed cancer
  • Receiving radiation therapy and/or chemotherapy
  • Minority and/or economically disadvantaged population

PATIENT CHARACTERISTICS:

  • Within any of the following service areas of 5 different hospitals in western Pennsylvania:

    • New Castle
    • Pittsburgh Metro
    • Somerset
    • Mckeesport
    • Johnstown
  • Any race, ethnicity, gender, or HIV status allowed

    • HIV serostatus is not evaluated specifically for study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400699

Locations
United States, Pennsylvania
Mercy Cancer Institute at Mercy Hospital     Recruiting
      Pittsburgh, Pennsylvania, United States, 15219
      Contact: Rudy Varesko, MD     412-232-7474        
Somerset Oncology Center     Recruiting
      Somerset, Pennsylvania, United States, 15501
      Contact: David S. Parda     814-444-1424        
UPMC Cancer Center - New Castle     Recruiting
      New Castle, Pennsylvania, United States, 16105
      Contact: Julian W. Proctor, MD, PhD     724-656-5870     proctorj@upmc.edu    
UPMC Cancer Center at UPMC McKeesport     Recruiting
      McKeesport, Pennsylvania, United States, 15132
      Contact: Clinical Trials Office - UPMC Cancer Center at UPMC McKeesport     412-647-8073        

Sponsors and Collaborators
UPMC Cancer Center at UPMC McKeesport
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Dwight E. Heron, MD     UPMC Cancer Center at UPMC McKeesport    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000513067, PCI-0408108
First Received:   November 16, 2006
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00400699
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
psychosocial effects/treatment  
unspecified adult solid tumor, protocol specific  

ClinicalTrials.gov processed this record on September 05, 2008




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