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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00400699
First received: November 16, 2006
Last updated: January 30, 2014
Last verified: January 2014
  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 of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Other: counseling intervention
Other: study of socioeconomic and demographic variables
Procedure: psychosocial assessment and care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

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

Enrollment: 3150
Study Start Date: October 2004
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
REview Other: counseling intervention Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
UPMC Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
Mercy Cancer Institute at Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Somerset Oncology Center
Somerset, Pennsylvania, United States, 15501
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight E. Heron, MD University of Pittsburgh
  More Information

Additional Information:
No publications provided

Responsible Party: Dwight Heron, MD, FACRO, FACR, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00400699     History of Changes
Obsolete Identifiers: NCT00304343
Other Study ID Numbers: PCI-0408108, CDR0000513067
Study First Received: November 16, 2006
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 14, 2014