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

21 Years
Open (Enrolling)
Breast Cancer, Colon Cancer

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Trial Information

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


- 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.


- 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.


- 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.


- 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.


- 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

Type of Study:


Study Design:


Outcome Measure:

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

Principal Investigator

Kathleen Castro, R.N.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

February 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • Disparities
  • Patient Reported Outcomes
  • Symptoms
  • Symptom Surveillance
  • Breast Neoplasms
  • Colonic Neoplasms



Lehigh Valley Hospital Allentown, Pennsylvania  18103
Hartford Hospital Hartford, Connecticut  06102-5037
Penrose Cancer Center Colorado Springs, Colorado  80933
Northside Hospital Atlanta, Georgia  30342
Christiana Care Health Services Newark, Delaware  19713
St. Joseph's/Candler Health System Savannah, Georgia  31405
Sanford Health Sioux Falls, South Dakota  57104
St. Joseph's Orange Orange, California  92868
Our Lady of the Lake/ Mary Bird Perkins Baton Rouge, Louisiana  70806
The Cancer Institute Catholic Health Initiatives Towson, Maryland  21204
Billings Clinical Cancer Center Billings, Montana  
CHI, St. Fancis Grand Island, Nebraska  68803
CHI, Good Samaritan Kearney, Nebraska  
Spartanburg Regional Hospital Spartanburg, South Carolina  29303
Ascension Health Systems Mikwaukee, Wisconsin  53211