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Computerized Assessment for Patients With Cancer (ESRA-C_II)

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ClinicalTrials.gov Identifier: NCT00852852
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 1, 2018
Sponsor:
Collaborators:
Fred Hutchinson Cancer Research Center
University of Washington
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Donna Berry, PhD, RN, FAAN, AOCN, Dana-Farber Cancer Institute

Tracking Information
First Submitted Date  ICMJE February 26, 2009
First Posted Date  ICMJE February 27, 2009
Last Update Posted Date February 1, 2018
Study Start Date  ICMJE October 2008
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2011)
Symptom burden and quality of life 2-4 weeks post treatment [ Time Frame: 3 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
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 ]
Change History Complete list of historical versions of study NCT00852852 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2009)
To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings. [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Computerized Assessment for Patients With Cancer
Official Title  ICMJE Computerized Assessment for Patients With Cancer-ESRA-C II
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2014)
779
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
952
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00852852
Other Study ID Numbers  ICMJE 08-284
R01NR008726 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Donna Berry, PhD, RN, FAAN, AOCN, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Fred Hutchinson Cancer Research Center
  • University of Washington
  • National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: Donna L. Berry Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date January 2018

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