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A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record

21 Years
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Advanced Cancer

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Trial Information

A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record

The Computer Program:

In this study, researchers will interview cancer patients receiving palliative care, their
caregivers, and doctors and nurses who work in palliative care.

The computer program will be designed to help doctors and nurses monitor the symptoms of
patients. The program will also be designed to help doctors and nurses make decisions about
how to care for patients.

Interview Session:

If you agree to take part in this study, you will be interviewed by a research staff member.
The study chair may also attend the interview. The interview will be held at the
Palliative Care outpatient clinic.

The interview session will be done in 3 steps, which are described below. Each step will
take about 10 minutes.

First, you will read questionnaires about patient symptoms. These questionnaires are drafts
of the ones that will be included in the software program.

You will then look at a draft of the computer program's layout.

Last, you will be interviewed. You will be asked to discuss your experiences as a patient
or caregiver in reporting symptoms and health status to doctors and nurses. You will also
be asked to discuss what might make the program more usable.

During the interview, you may also be asked to answer sample questions on the draft
questionnaires and discuss how readable you think the questions are. For example, you will
discuss your opinion about the font size, text placement, and color scheme.

Study Data:

The interview session will be audio-taped. To protect your confidentiality, only your first
name will be used during the interview session. Patients and their caregivers will also be
interviewed separately to protect privacy.

Patient responses will not be disclosed to caregivers, and caregiver responses will not be
disclosed to patients. The patient's palliative care doctor will be told, however, if
patients or caregivers show signs of emotional difficulties.

When the audio recording is transcribed (typed) by the research staff, all names will be
coded so that no one can be identified by name. The audio recordings will be stored in
password-protected files that are available only to the study chair and staff.

After the results of the study are published, the audio recordings will be destroyed by the
study staff.

Length of Study:

Your study participation will be over after the interview session.

This is an investigational study.

Up to 26 participants will be enrolled in this study. This includes up to 9 patients and 9
caregivers in this part of the study, and up to 4 doctors and 4 nurses in a second part of
the study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. All patient/caregiver participants will be adults 21 years of age or older.

2. Patient participants will be palliative care cancer patients and their caregivers.

3. Participating patients should be receiving palliative care at the MD Anderson Cancer

4. Patient must be able to speak, read and write English

5. Physician and nurse experts in palliative care will be eligible for participation on
the study's expert panel. (For study purposes, a physician or nurse expert is defined
as a physician or nurse with a minimum of four years experience working in a
palliative care setting.

6. Physician and nurse experts will be eligible for participation in study interviews if
they have a minimum of four years experience working in a palliative care setting.

Exclusion Criteria:

1. Patients who are not able to self-report their symptom status using either
paper-and-pencil or electronic tools.

2. Patients or caregivers who do not agree to sign the study's informed consent

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Define Patient-Reported Outcomes (PRO)-based Palliative/Hospice Care Model Integrating PRO Results with Evidence-based Treatment Guidelines and Pathways to Care

Outcome Description:

Through focused interviews with specific tasks: review PRO domains and questionnaires for the care mode; review user interface design and work flow; discuss user expectations of the system to assess the usability of a system's user interface design.

Outcome Time Frame:

2 Years

Safety Issue:


Principal Investigator

Michael A. Kallen, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

March 2009

Completion Date:

September 2011

Related Keywords:

  • Advanced Cancer
  • Cancer
  • Computer Program
  • Palliative Care
  • Patient-Reported Outcomes
  • PRO
  • Palliative and Hospice Care Practice
  • Electronic Health Record
  • EHR
  • Interview
  • Neoplasms



UT MD Anderson Cancer CenterHouston, Texas  77030