Cancer Symptom Data From Multiple Treatment Centers



Status:Completed
Conditions:Breast Cancer, Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:8/11/2018
Start Date:February 10, 2012

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The NCl Community Cancer Center Program Patients Reported Symptom Surveillance and Disparities Study

Background:

- Cancer and cancer treatments can cause symptoms and side effects. Pain, fatigue, and
emotional distress are three common symptoms. Accurate reporting of these symptoms can
improve treatment methods and outcomes. Even though symptom reporting is important to
treatment, there is no method to collect and compare patient data from multiple cancer care
centers. Researchers want to develop a method for collecting cancer patient symptom
information from multiple centers. This method may help improve cancer treatment at hospitals
and other care centers.

Objectives:

- To collect patient-reported symptom information from multiple cancer care centers.

Eligibility:

- Individuals at least 21 years of age who were treated for breast or colon cancer in the
past year.

- Participants will come from one of the participating cancer care centers.

Design:

- Participants will answer a short questionnaire about their symptoms during cancer
treatment. Questions will ask about symptom severity and experiences. Other questions
will ask how well the doctors and nurses managed the symptoms.

- Participant responses will be compared with other medical and personal information. This
information may include cancer type, age at diagnosis, and type of treatment.

- Treatment will not be provided as part of this study.

Background:

- Cancer and its treatment lead to symptoms and side effects. Pain, fatigue, and emotional
distress are three of the most common and distressing symptoms. Patient report is the
gold standard for assessing these symptoms and is critical to patient-centered care.

- Symptoms are often under-reported or under-treated leading to impairments in quality of
life, functioning, and treatment adherence. Factors contributing to
under-reporting/treatment occur within patients (e.g., fear of addiction to pain meds),
providers (e.g., lack of training), and the healthcare system (e.g., under-insurance).

- A limited number of studies suggest that the burden symptoms falls unevenly on certain
racial/ethnic, socioeconomic status (SES), and insurance status groups.

- Despite the importance of symptoms in cancer care, there is no method for systematically
collecting patient reported data at institutional or national levels. Such a system
could identify at risk groups, inform intervention, and ultimately improve quality of
care.

- This study uses existing resources to design a cost-effective symptom surveillance
system. The NCI Community Cancer Center Program (NCCCP) provides the infrastructure for
efficiently conducting a multi-site pilot in a real-world setting with a diverse sample
of patients. The Commission on Cancer s Rapid Quality Reporting System (RQRS) will
automate sampling to minimize burden on the cancer center s staff, facilitate data
collection during or soon after treatment, and protect patients personal identifiers.
The survey instrument is based upon previously validated measures.

Objectives:

- To pilot a method for collecting patient reports of symptom-related experiences that
could be used for surveillance at institutional and, in the future, population levels.

- To investigate disparities in symptom burden and management between racial/ethnic, SES,
and health insurance status groups.

- To pilot the use of patient-reported symptom data for quality improvement of symptom
management at participating cancer centers.

Eligibility:

- Diagnosed with Stage I-III breast or colon cancer as first primary cancer between
February 2011 and January 2013

- Age of 21 years or older

- Received cancer care from one of 17 participating NCCCP Cancer Centers.

Design:

- This cross-sectional survey will collect reports of symptoms and related experiences
from patients 3-12 months after cancer diagnosis via mailed questionnaire. A
methodological experiment will randomize patients after the second mailing to compare
telephone follow-up to a third mailing. Data on cost and Cancer Center staff time will
be collected to provide scalable estimates of overall cost and examine
cost-effectiveness of telephone follow-up.

- The study will provide prevalence estimates for various symptoms and symptom management
items. More complex, model-based statistics will be used to investigate symptom
disparities (Aim 2). For these models, outcomes will be either continuous (e.g., pain
severity) or ordinal (e.g., symptom management items) and will be analyzed using
Generalized Linear Mixed Models (GLMM) to take into account the two-level structure of
the data (patients nested within Cancer Centers). We expect to enroll 2,550 patients.

- INCLUSION CRITERIA:

The respondent universe will consist of all cancer patients at the 16 participating NCCCP
Cancer Centers who satisfy the following conditions:

- Diagnosed with Stage I-III breast or colon cancer as first primary cancer between
February 2011 and January 2013

- Eligible for one of the RQRS breast or colon Quality of Care Indicators

- Age of 21 or older

- Not known to be deceased at the time of contact

The NCCCP is a network of 30 community hospitals in 22 states supporting cancer research
and enhancing cancer care for patients close to home. Most cancer patients in the U.S. are
diagnosed and treated at community hospitals; not in NCI Comprehensive Cancer Centers where
much research is conducted. The National Cancer Institute Community Cancer Centers Program
(NCCCP) is expanding cancer research and bringing advanced cancer treatments to patients in
community hospitals in rural, suburban and inner-city areas.

This study is being conducted at the 16 pilot NCCCP sites that first entered the program in
2007. All 16 participate in RQRS. These 16 pilot sites are located in 14 states throughout
the United States.

EXCLUSION CRITERIA:

- Patients will be excluded for the following reasons:Patient is ineligible for one of
the 5 RQRS breast or colon quality indicators

- Patient is deceased at the time of sampling

- Patient has Stage IV cancer
We found this trial at
15
sites
Newark, Delaware 19713
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
Lehigh Valley Hospital At Lehigh Valley Health Network, we continually go the extra mile to...
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Allentown, PA
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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Atlanta, GA
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Baton Rouge, Louisiana 70806
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Baton Rouge, LA
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Billings, MT
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Colorado Springs, Colorado 80907
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Colorado Springs, CO
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Grand Island, Nebraska 68803
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Grand Island, NE
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hartford, CT
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Kearney, Nebraska
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Kearney, NE
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2301 North Lake Drive
Milwaukee, Wisconsin 53211
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Milwaukee, WI
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Orange, California 92868
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Orange, CA
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Savannah, Georgia 31405
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Savannah, GA
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Sioux Falls, South Dakota 57104
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Sioux Falls, SD
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Towson, MD
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