Computerized Assessment for Patients With Cancer

NCT00194493 | Completed Phase 3 DMC

• 2 other identifiers: APP00000089R01NR008726
• Study Type: interventional
• Target: 1,058
• Locations: 1 country
• Sites: 2

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.

Conditions

Neoplasms

Keywords

Cancer; Quality of Life; Signs and Symptoms; Computers; Patient-Reported Outcomes

Outcome Measures

Primary Outcomes (4)

• Frequency of QOL and symptom topics being addressed in audiotaped patient/clinician visits

  Study end

• Frequency of QOL and symptom information being documented by clinician in the medical record within 24 hours

  Study end

• Frequency of appropriate symptom interventions recommended by clinicians and documented in the medical record

  Study end

• Frequency of appropriate referrals to specialty or support services subsequent to assessment.

  Study end

Secondary Outcomes (2)

• Process Variables (Efficiency process,Usability process)

  Study end

• Clinical Significance (Score change over time,Magnitude of change, Response shift)

  Study end

Study Arms (2)

1

EXPERIMENTAL

Patient's clinician receives graphical report of patient-reported symptoms and quality of life issues.

Behavioral: ESRA-C

2

NO INTERVENTION

Interventions

ESRA-C BEHAVIORAL

Graphical summary of patient symptoms and quality of life

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cancer

You may not qualify if:

• Less than 18 years of age
• Non-english speaking

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• University of Washington: collaborator

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Neoplasms; Signs and Symptoms

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms

Study Officials

• Donna L Berry, PHD RN

  School of Nursing, University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: April 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2008
• Last Updated: May 4, 2015

Record last verified: 2015-04

Locations

US (2)