Computerized Assessment for Patients With Cancer (ESRA-C_II)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Washington
Information provided by (Responsible Party):
Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00852852
First received: February 26, 2009
Last updated: October 21, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Computerized Assessment for Patients With Cancer-ESRA-C II

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Symptom burden and quality of life 2-4 weeks post treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 952
Study Start Date: October 2008
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852852

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Fred Hutchinson Cancer Research Center
University of Washington
Investigators
Principal Investigator: Donna L. Berry Dana-Farber Cancer Institute
  More Information

No publications provided by Dana-Farber Cancer Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Donna Berry, PhD, RN, FAAN, ACON, Assoc. Professor, Harvard Medical School; Director, The Phyllis F. Cantor Center, Research in Nursing and Patient Care Services; Affiliate Professor, University of Washington School of Nursing, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00852852     History of Changes
Other Study ID Numbers: 08-284, R01NR008726
Study First Received: February 26, 2009
Last Updated: October 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
ESRA-C 2
computerized assessment

ClinicalTrials.gov processed this record on August 27, 2014