Computerized Assessment for Patients With Cancer

Cancer Clinical Trial

— ESRA-C_II  

Official title:

Computerized Assessment for Patients With Cancer-ESRA-C II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00852852
• Other study ID #: 08-284
• Secondary ID: R01NR008726
• Status: Completed
• Phase: N/A
• First received: February 26, 2009
• Last updated: January 30, 2018
• Start date: October 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2018
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study will test a new online computer program for patients, the Electronic Self-Report Assessment-Cancer (ESRA-C 2). The program allows patients to report symptoms and quality of life issues and learn information about how to deal with these experiences. The computer program is being tested to see if it can improve communications between patients and their care team and if it can improve patients' experiences during and after treatment.

Description:

• This study includes two groups of participants: 1) Clinician Participants and 2) Patient Participants.

• Patient participants will have already completed one ESRA-C 2 report, which is a usual report in the clinic. If they decide to participate in the study, that report will be used in the study as the first report (Timepoint 1). In addition, they will complete a second report (Timepoint 2) and two more reports (Timepoint 3 and 4). Timepoint 3 will be 6-8 weeks after the participants treatment begins; Timepoint 4 will be 2-4 weeks after their treatment ends.

• The Timepoint 2 report will be within 24 hours before a clinic visit. The conversation between the patient participant and the health care providers will be audio recorded.

• Half of the patient participants will also see additional information in the computer program. The patient participants that are in this group can complete as many more ESRA-C 2 reports as they wish and will be able to read additional information about managing symptoms and quality of life issues, view graphs of their reports, add journal entries, and share all their reports with caregivers.

• Clinician Participants will be asked to report brief demographics (age group, gender, race/ethnicity, position). During clinic appointments, research staff will place a 3" by 5" audio-recorder in the exam room just prior to some of the participant's visits. Recordings will be de-identified before coding.

• After these visits, a research staff member will ask the clinician participant to report briefly on their satisfaction in the visit. The participant can check their responses on a piece of paper or dictate them.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 779
• Est. completion date: December 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Eligible clinician participants (Inclusion):

• Nurses, physicians, or physician assistants

• Perform consults/exams in clinics that have implemented routine use of the ESRA-C 2 screening tool as a standard of care

Eligible patient participants (Inclusion):

• 18 years of age or older

• Diagnosis of malignant disease

• Plan to have treatment in a study clinic

• Speak and read English at a 6th grade level or higher

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Electronic Self-Report Assessment - Cancer (ESRA-C)
The Electronic Self-Report Assessment-Cancer (ESRA-C) is a program allowing patients to report symptoms and quality of life issues and learn information about how to deal with these experiences.

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of Washington Medical Center	Seattle	Washington

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Fred Hutchinson Cancer Research Center, National Institute of Nursing Research (NINR), University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom burden and quality of life 2-4 weeks post treatment		3 years
Secondary	To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings.		3 years