Computerized Assessment for Patients With Cancer

Neoplasms Clinical Trial

— ESRA-C  

Official title:

Computerized Assessment for Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00194493
• Other study ID #: APP00000089
• Secondary ID: R01NR008726
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: April 30, 2015
• Start date: April 2005
• Est. completion date: June 2008

Study information

• Verified date: April 2015
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1058
• Est. completion date: June 2008
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of Cancer

Exclusion Criteria:

• Less than 18 years of age

• Non-english speaking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Behavioral:
• ESRA-C
Graphical summary of patient symptoms and quality of life

Locations

Country	Name	City	State
United States	Seattle Cancer Care Alliance	Seattle	Washington
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of QOL and symptom topics being addressed in audiotaped patient/clinician visits		Study end	No
Primary	Frequency of QOL and symptom information being documented by clinician in the medical record within 24 hours		Study end	No
Primary	Frequency of appropriate symptom interventions recommended by clinicians and documented in the medical record		Study end	No
Primary	Frequency of appropriate referrals to specialty or support services subsequent to assessment.		Study end	No
Secondary	Process Variables (Efficiency process,Usability process)		Study end	No
Secondary	Clinical Significance (Score change over time,Magnitude of change, Response shift)		Study end	No