Cancer Symptom Data From Multiple Treatment Centers

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer

• NCT number: NCT01547845
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Status: Completed
• Start date: February 10, 2012
• Completion date: May 23, 2019