Computerized Assessment for Patients With Cancer (ESRA-C)
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | May 7, 2012 | ||||
| Start Date ICMJE | April 2005 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00194493 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computerized Assessment for Patients With Cancer | ||||
| Official Title ICMJE | Computerized Assessment for Patients With Cancer | ||||
| Brief Summary | The traditional procedure for cancer symptom and quality of life instrument administration is a paper questionnaire completed by the patient or research participant. The use of standardized, patient report instruments as routine assessment in clinical cancer care has been promoted, but infrequently reported and the utilization rate is low. Barriers to clinical use include the personnel cost of data collection, management of written questionnaires and the clinicians' unfamiliarity with the nature of the queries and numerical scale scores. Web-based electronic technology now has been developed and tested for feasibility using touchscreen, notebook computers and the computerized assessment program, a screening assessment providing usable and easily interpreted graphic output to cancer clinicians. The purpose of this study is to design and evaluate the clinical integration of the web-based computerized assessment in a major, multi-disciplinary academic medical center and cancer center. Consecutive outpatients who are evaluated for cancer therapy in each of the 2 setting sites, the University of Washington Medical Center and the Seattle Cancer Care Alliance, are able to communicate in English (or through one of the many interpreters available at the institutions), and are competent to understand the study information and give informed consent will be invited to participate. Clinicians caring for the patients in the sample will be invited to participate in evaluating the organizational impact. We will compare the outcomes of conducting assessment in the usual practices and procedures to the outcomes of using the computerized assessment program: appropriateness of referrals, efficiency, and usability. The computerized assessment will be completed prior to each participant's visit with the clinician, conducted at the first clinic visit, during the 4-6th week of treatment and again at a 30 day follow up visit. Graphical output will be immediately available to clinicians. Descriptive, comparative statistics will be used to evaluate the impact of the screening and longitudinal assessments. |
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| 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.
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Neoplasms | ||||
| Intervention ICMJE | Behavioral: ESRA-C
Graphical summary of patient symptoms and quality of life |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1058 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00194493 | ||||
| Other Study ID Numbers ICMJE | APP00000089, R01NR008726 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute | ||||
| Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||
| Collaborators ICMJE | University of Washington | ||||
| Investigators ICMJE |
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| Information Provided By | Dana-Farber Cancer Institute | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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