Cancer Symptom Data From Multiple Treatment Centers

This study is currently recruiting participants.
Verified June 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01547845
First received: March 6, 2012
Last updated: March 14, 2014
Last verified: June 2013
  Purpose

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.

Condition
Breast Cancer
Colon Cancer

Study Type: Observational
Official Title: The NCl Community Cancer Center Program Patients Reported Symptom Surveillance and Disparities Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • To investigate in symptom burden and management between racial/ethnic, socio economic status, and health insurance groups. To pilot the use of patient-reported symptom data for Quality Improvement of symptom management at centers.

Estimated Enrollment: 2550
Study Start Date: February 2012
Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547845

Contacts
Contact: Kathleen Castro, R.N. (301) 594-6642 castrok@mail.nih.gov

Locations
United States, California
St. Joseph's Orange Recruiting
Orange, California, United States, 92868
United States, Colorado
Penrose Cancer Center Recruiting
Colorado Springs, Colorado, United States
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States
United States, Georgia
Northside Hospital Recruiting
Atlanta, Georgia, United States, 30042
St. Joseph's/Candler Health System Recruiting
Savannah, Georgia, United States
United States, Louisiana
Our Lady of the Lake/ Mary Bird Perkins Recruiting
Baton Rouge, Louisiana, United States, 70806
United States, Maryland
The Cancer Institute Catholic Health Initiatives Recruiting
Towson, Maryland, United States, 21204
United States, Montana
Billings Clinical Cancer Center Recruiting
Billings, Montana, United States
United States, Nebraska
CHI, St. Fancis Recruiting
Grand Island, Nebraska, United States, 68803
CHI, Good Samaritan Recruiting
Kearney, Nebraska, United States
United States, Pennsylvania
Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18105-1556
United States, South Carolina
Spartanburg Regional Hospital Recruiting
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Health Recruiting
Sioux Falls, South Dakota, United States, 57117
United States, Wisconsin
Ascension Health Systems Recruiting
Mikwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
Investigators
Principal Investigator: Kathleen Castro, R.N. National Cancer Institute (NCI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT01547845     History of Changes
Other Study ID Numbers: 999912039, 12-C-N039
Study First Received: March 6, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Disparities
Patient Reported Outcomes
Symptoms
Symptom Surveillance

Additional relevant MeSH terms:
Breast Neoplasms
Colonic Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 16, 2014