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Completed

NCT Number: NCT00852852

Computerized Assessment for Patients With Cancer

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electronic Self-Report Assessment - Cancer (ESRA-C)

Behavioral

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.

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. To assess the feasibility of delivering a patient oriented, patient-controlled ESRA-C directly to patients outside clinically settings.

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • Fred Hutchinson Cancer Center
  • National Institute of Nursing Research (NINR)
  • University of Washington

Registry information

Official study title

Computerized Assessment for Patients With Cancer-ESRA-C II

Acronym: ESRA-C_II

Important dates

Study start
2008
Primary completion
2011
Study completion
2013
First posted
Feb 27, 2009
Registry last updated
Feb 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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