Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194493
Status:
COMPLETED
Last Update Posted:
2015-05-04
First Post:
2005-09-12
Brief Title:
Computerized Assessment for Patients With Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Computerized Assessment for Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2015-04
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:
ESRA-C
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 participants 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
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 patients 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 andor 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 20002001 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
Clinicians and researchers developed and pilot-tested the ESRA-C prototype in 20002001 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 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 |
|---|---|---|---|
| R01NR008726 | NIH | None | httpsreporternihgovquickSearchR01NR008726 |