- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00194493
Computerized Assessment for Patients With Cancer (ESRA-C)
Study Overview
Detailed Description
Patients with cancer, across a wide range of diagnoses and stages, have a high incidence of symptoms that may greatly impact quality of life. The consequences of inadequate symptom assessment and management are profound, complex, and can be overwhelming to patients and their caregivers. However, clinicians are faced too often with shrinking resources, removing opportunities for comprehensive, interpersonal interactions with patients. The patient's experience, particularly symptoms and quality of life (QOL) concerns, reported in a reliable and systematic way, is an essential component of the information on which a complete clinical assessment, diagnosis and treatment plan is based. Computer technology has been developed for patient self-reporting of symptom and QOL data using validated survey instruments delivered on notebook computers, personal digital assistants, and over the Web. Not only do these devices eliminate the usual steps of abstracting patient interview data and/or keying in marked responses, but the interfaces also permit customized, confidential and private assistance with answering queries more completely. While the reports are few, the results are positive: data integrity is enhanced by the computerized assessment, and patients prefer, and are easily able to complete the computerized versions. Furthermore, computerized screening procedures have demonstrably enhanced communication between clinicians and patients and successfully identified psychologically distressed patients with cancer.
- Clinicians and researchers developed and pilot-tested the ESRA-C prototype in 2000/2001 at the University of Washington Medical Center Cancer Center. The successful implementation was published in 2004 in the Oncology Nursing Forum. [8]
- The purpose of this new randomized trial is to evaluate the clinical use of our web-based ESRA-C throughout the Seattle Cancer Care Alliance.
- Two patients per month per team (Transplant) or per provider (Radiation Oncology, Medical Oncology) will be enrolled in this study.
- Patients will use the system to self-assess their symptoms and QOL at 2 time points, before (T1) and after treatment (T2)
- At the second, on-treatment assessment, the intervention group patients will have a color-graphic summary of their answers from both T1 and T2 delivered to the clinical team before the clinic visit with the patient.
- Both intervention and control participants will have the T2 clinic visit audio-recorded. Clinician data will be anonymously entered and audio-files destroyed.
- Using chart reviews we will abstract any notations, therapies ordered, prescriptions written and referrals made, relevant to symptoms and quality of life issues. This will be documented without clinician identifiers.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington Medical Center
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Seattle, Washington, United States, 98109-1023
- Seattle Cancer Care Alliance
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diagnosis of Cancer
Exclusion Criteria:
- Less than 18 years of age
- Non-english speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
|
|
Experimental: 1
Patient's clinician receives graphical report of patient-reported symptoms and quality of life issues.
|
Graphical summary of patient symptoms and quality of life
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Frequency of QOL and symptom topics being addressed in audiotaped patient/clinician visits
Time Frame: Study end
|
Study end
|
Frequency of QOL and symptom information being documented by clinician in the medical record within 24 hours
Time Frame: Study end
|
Study end
|
Frequency of appropriate symptom interventions recommended by clinicians and documented in the medical record
Time Frame: Study end
|
Study end
|
Frequency of appropriate referrals to specialty or support services subsequent to assessment.
Time Frame: Study end
|
Study end
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Process Variables (Efficiency process,Usability process)
Time Frame: Study end
|
Study end
|
Clinical Significance (Score change over time,Magnitude of change, Response shift)
Time Frame: Study end
|
Study end
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Donna L Berry, PHD RN, School of Nursing, University of Washington
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APP00000089
- R01NR008726 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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