Computerized Assessment for Patients With Cancer (ESRA-C)
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|ClinicalTrials.gov Identifier: NCT00194493|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : May 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Behavioral: ESRA-C||Phase 3|
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. 
- 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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||1058 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Computerized Assessment for Patients With Cancer|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2008|
Patient's clinician receives graphical report of patient-reported symptoms and quality of life issues.
Graphical summary of patient symptoms and quality of life
|No Intervention: 2|
- Frequency of QOL and symptom topics being addressed in audiotaped patient/clinician visits [ Time Frame: Study end ]
- Frequency of QOL and symptom information being documented by clinician in the medical record within 24 hours [ Time Frame: Study end ]
- Frequency of appropriate symptom interventions recommended by clinicians and documented in the medical record [ Time Frame: Study end ]
- Frequency of appropriate referrals to specialty or support services subsequent to assessment. [ Time Frame: Study end ]
- Process Variables (Efficiency process,Usability process) [ Time Frame: Study end ]
- Clinical Significance (Score change over time,Magnitude of change, Response shift) [ Time Frame: Study end ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194493
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109-1023|
|University of Washington Medical Center|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Donna L Berry, PHD RN||School of Nursing, University of Washington|