Computerized Assessment for Patients With Cancer (ESRA-C_II)

Computerized Assessment for Patients With Cancer-ESRA-C II

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 779
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute
  • Washington
    • Seattle, Washington, United States, 98115
      • University of Washington Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Patient participants in the intervention arm can access educational information about self-care strategies, track and share reports of their symptoms and quality of life issues over time, and receive coaching on how to discuss these issues with their care team.	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.
No Intervention: Control; Participants in the control arm access the ESRA-C from home or clinic to self-assess only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Symptom burden and quality of life 2-4 weeks post treatment	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings.	3 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Institute of Nursing Research (NINR); University of Washington; Fred Hutchinson Cancer Center
• Investigators: Principal Investigator: Donna L. Berry, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• Knoerl R, Hong F, Blonquist T, Berry D. Impact of Electronic Self-Assessment and Self-Care Technology on Adherence to Clinician Recommendations and Self-Management Activity for Cancer Treatment-Related Symptoms: Secondary Analysis of a Randomized Controlled Trial. JMIR Cancer. 2019 Jan 8;5(1):e11395. doi: 10.2196/11395.
• Knoerl R, Weller E, Halpenny B, Berry D. Exploring the efficacy of an electronic symptom assessment and self-care intervention to preserve physical function in individuals receiving neurotoxic chemotherapy. BMC Cancer. 2018 Dec 4;18(1):1203. doi: 10.1186/s12885-018-5093-z. Erratum In: BMC Cancer. 2019 May 13;19(1):438.
• Siefert ML, Bonquist TM, Berry DL, Hong F. Symptom-related emergency department visits and hospital admissions during ambulatory cancer treatment. J Community Support Oncol. 2015 May;13(5):188-94. doi: 10.12788/jcso.0134.
• Berry DL, Blonquist TM, Patel RA, Halpenny B, McReynolds J. Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress. J Med Internet Res. 2015 Jun 3;17(6):e136. doi: 10.2196/jmir.4190.
• Berry DL, Hong F, Halpenny B, Partridge A, Fox E, Fann JR, Wolpin S, Lober WB, Bush N, Parvathaneni U, Amtmann D, Ford R. The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC Cancer. 2014 Jul 12;14:513. doi: 10.1186/1471-2407-14-513.
• Hong F, Bosco JL, Bush N, Berry DL. Patient self-appraisal of change and minimal clinically important difference on the European organization for the research and treatment of cancer quality of life questionnaire core 30 before and during cancer therapy. BMC Cancer. 2013 Mar 28;13:165. doi: 10.1186/1471-2407-13-165.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 26, 2009
• First Submitted That Met QC Criteria: February 26, 2009
• First Posted (Estimate): February 27, 2009

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: computerized assessment; ESRA-C 2
• Other Study ID Numbers: 08-284; R01NR008726 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No