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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400699
• Other study ID #: PCI-0408108
• Secondary ID: CDR0000513067
• Status: Completed
• Phase: N/A
• First received: November 16, 2006
• Last updated: January 30, 2014
• Start date: October 2004

Study information

• Verified date: January 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00304343

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3150
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Other:
• counseling intervention

• study of socioeconomic and demographic variables

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical stage at time of presentation (indicator of early access to system)		Observation	No
Primary	Date and nature of post-diagnosis surgery or biopsy		Observation	No
Primary	Proportion of patients compliant with treatment plan		Observation	No
Primary	Total radiation dosage per patient (curative and palliative endpoints)		Observation	No
Primary	Supportive services provided to patients		Observation	No
Primary	Rate of treatment completion		Observation	No
Primary	Accrual for clinical research protocols		Observation	No
Primary	Retention in clinical research protocols		Observation	No
Primary	Barriers to treatment (perceived and real)		Observation	No