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Computerized Assessment for Patients With Cancer-ESRA-C II

Phase 3
18 Years
Open (Enrolling)

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Trial Information

Computerized Assessment for Patients With Cancer-ESRA-C II

- 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.

Inclusion 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

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Symptom burden and quality of life 2-4 weeks post treatment

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Donna L. Berry

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

December 2012

Related Keywords:

  • Cancer
  • ESRA-C 2
  • computerized assessment



University of Washington Medical Center Seattle, Washington  98195-6043
Dana-Farber Cancer Institute Boston, Massachusetts  02115