Clinical trial NCT00400699: Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer
Official title: UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Effects of Cancer and Its Treatment
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: psychosocial effects of cancer and its treatment
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-17
Enrollment: 3150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Clinical stage at time of presentation (indicator of early access to system)
timeFrame: Observation
measure: Date and nature of post-diagnosis surgery or biopsy
timeFrame: Observation
measure: Proportion of patients compliant with treatment plan
timeFrame: Observation
measure: Total radiation dosage per patient (curative and palliative endpoints)
timeFrame: Observation
measure: Supportive services provided to patients
timeFrame: Observation
measure: Rate of treatment completion
timeFrame: Observation
measure: Accrual for clinical research protocols
timeFrame: Observation
measure: Retention in clinical research protocols
timeFrame: Observation
measure: Barriers to treatment (perceived and real)
timeFrame: Observation
Secondary outcomes:
Other outcomes:
Locations:
city: McKeesport
country: United States
facility: UPMC Cancer Center at UPMC McKeesport
state: Pennsylvania
city: New Castle
country: United States
facility: UPMC Cancer Center - New Castle
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Mercy Cancer Institute at Mercy Hospital
state: Pennsylvania
city: Somerset
country: United States
facility: Somerset Oncology Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Dwight E. Heron, MD
role: PRINCIPAL_INVESTIGATOR
References: