Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: A Qualitative Study

September 20, 2011 updated by: M.D. Anderson Cancer Center

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

The goal of this research study is to collect information to plan how to design a computer program for cancer patients receiving palliative care, their caregivers, and doctors and nurses who work in palliative care. Researchers want to learn how to make this program practical for use by future patients, caregivers, doctors, and nurses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

UT MD Anderson Cancer Center (MDACC) cancer patients, 21 years of age or older, receiving palliative care, their caregivers, and UT MDACC physicians and nurses who work in palliative care.

Description

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 Center.
  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 document.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Interview
Behavioral: Interview
3 step process including person to person meeting and questionnaires taking about 30 minutes.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Define Patient-Reported Outcomes (PRO)-based Palliative/Hospice Care Model Integrating PRO Results with Evidence-based Treatment Guidelines and Pathways to Care
Time Frame: 2 Years
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.
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Michael A. Kallen, PhD, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

April 7, 2009

First Submitted That Met QC Criteria

April 7, 2009

First Posted (Estimate)

April 8, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-0840

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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