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

February 26, 2009
October 21, 2013
October 2008
July 2011   (final data collection date for primary outcome measure)
Symptom burden and quality of life 2-4 weeks post treatment [ Time Frame: 3 years ] [ Designated as safety issue: No ]
The primary objective of this protocol is to compare the impact of ESRA-C 2 summaries delivered to patients and clinicians, to ESRA-C 2 summaries delivered solely to clinical providers. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00852852 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Computerized Assessment for Patients With Cancer
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.

  • 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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancer
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.
  • 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.
    Intervention: Behavioral: Electronic Self-Report Assessment - Cancer (ESRA-C)
  • No Intervention: Control
    Participants in the control arm access the ESRA-C from home or clinic to self-assess only.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
952
December 2014
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00852852
08-284, R01NR008726
Yes
Donna Berry, PhD, RN, FAAN, ACON, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Fred Hutchinson Cancer Research Center
  • University of Washington
  • National Institute of Nursing Research (NINR)
Principal Investigator: Donna L. Berry Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP