Ignite Creation Date:
2024-05-06 @ 12:19 AM
Last Modification Date:
2024-10-26 @ 10:48 AM
Study NCT ID:
NCT01547845
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2012-03-06
Brief Title:
Cancer Symptom Data From Multiple Treatment Centers
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The NCl Community Cancer Center Program Patients Reported Symptom Surveillance and Disparities Study
Status:
COMPLETED
Status Verified Date:
2019-05-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
- 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
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-reportingtreatment occur within patients eg fear of addiction to pain meds providers eg lack of training and the healthcare system eg under-insurance
A limited number of studies suggest that the burden symptoms falls unevenly on certain racialethnic 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 racialethnic 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 eg pain severity or ordinal eg 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 2550 patients
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-reportingtreatment occur within patients eg fear of addiction to pain meds providers eg lack of training and the healthcare system eg under-insurance
A limited number of studies suggest that the burden symptoms falls unevenly on certain racialethnic 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 racialethnic 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 eg pain severity or ordinal eg 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 2550 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 12-C-N039 | None | None | None |