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

NCT ID: NCT00400699

Last Updated: 2014-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31

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 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.

Conditions

Psychosocial Effects of Cancer and Its Treatment; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

REview

Group Type: OTHER

counseling intervention

Intervention Type: OTHER

study of socioeconomic and demographic variables

Intervention Type: OTHER

psychosocial assessment and care

Intervention Type: PROCEDURE

Interventions

counseling intervention

Intervention Type: OTHER

study of socioeconomic and demographic variables

Intervention Type: OTHER

psychosocial assessment and care

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Dwight Heron

MD, FACRO, FACR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dwight E. Heron, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

UPMC Cancer Center at UPMC McKeesport

McKeesport, Pennsylvania, United States

UPMC Cancer Center - New Castle

New Castle, Pennsylvania, United States

Mercy Cancer Institute at Mercy Hospital

Pittsburgh, Pennsylvania, United States

Somerset Oncology Center

Somerset, Pennsylvania, United States

Countries

United States

Other Identifiers

CDR0000513067

Identifier Type: REGISTRY

Identifier Source: secondary_id

PCI-0408108

Identifier Type: -

Identifier Source: org_study_id

NCT00304343

Identifier Type: -

Identifier Source: nct_alias