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Completed

NCT Number: NCT00400699

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

study of socioeconomic and demographic variables

Other

psychosocial assessment and care

Procedure

Primary outcomes

  1. Clinical stage at time of presentation (indicator of early access to system)

    Time frame: Observation

  2. Date and nature of post-diagnosis surgery or biopsy

    Time frame: Observation

  3. Proportion of patients compliant with treatment plan

    Time frame: Observation

  4. Total radiation dosage per patient (curative and palliative endpoints)

    Time frame: Observation

  5. Supportive services provided to patients

    Time frame: Observation

  6. Rate of treatment completion

    Time frame: Observation

  7. Accrual for clinical research protocols

    Time frame: Observation

  8. Retention in clinical research protocols

    Time frame: Observation

  9. Barriers to treatment (perceived and real)

    Time frame: Observation

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program

Important dates

Study start
2004
Primary completion
2009
First posted
Nov 17, 2006
Registry last updated
Jan 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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