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CompletedNCT01024166Updated Jun 7, 2013

Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study

An observational study in Advanced Cancers, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-07.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
18
Ages
21 Years and older
Sex
All
01

Study summary

The goal of this research study is to learn if palliative care patients or caregivers, and palliative care physicians or nurses can use a computer program designed to provide information about the symptoms and overall health of cancer patients.

Read the detailed description

The Patient-Reported Outcomes (PRO) Computer System:

The PRO computer system used in this study has been designed to help doctors and nurses check the symptoms and overall health status of patients with cancer by reviewing the computer entries of patients and caregivers. The system has also been designed to help doctors and nurses make decisions about how to care for patients based on the computer entries.

Questionnaire and Review Session:

If you agree to take part in this study, you will have an questionnaire and review session at the Palliative Care outpatient clinic. The session will be conducted by a research staff member, but the study chair and/or other study staff members may also attend the session. The questionnaire and review session will have 3 steps, which are described below:

  • If you are a patient receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms you may be experiencing and your overall health. If you are a caregiver for someone who is receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms that the patient you are caring for may be experiencing and their overall health. The study staff will instruct you on how to use the PRO computer system.
  • If you are a physician or nurse, you will use the PRO computer system to complete 4 questionnaires about the symptoms and overall health of patients who are receiving palliative care. The study staff will instruct you on how to use the PRO computer system.
  • You will then look at the results of the questionnaires you have completed, which will be shown to you in both number and graph form. You will also be shown other features and potential uses of the PRO computer system.
  • Last, you will be asked about how easily you were able to use the computer system. You will also be asked about any changes you think could make the program easier to use.

The questionnaire and review session should take about 30 minutes to complete.

Study Data:

Your responses to the questionnaires will be destroyed after the questionnaire and review session. The responses you give when asked about the use of the PRO computer system will be kept after the questionnaire and review session. Only the study staff will have access to your responses. However, your responses will be coded with a study ID number, not by your name. Your saved responses will be stored in password-protected files that are available only to the study staff for 3 years.

Length of Study:

Your participation in this study will be over after you complete the questionnaire and review session.

This is an investigational study.

Up to 9 patients and 9 caregivers will take part in this study. All will be enrolled at M. D. Anderson.

Up to 9 physicians and nurses (4-5 of each) will take part in this study. All will be enrolled at M. D. Anderson.

02

Conditions studied

  • Advanced Cancers

Keywords

  • Cancer
  • Patient-Reported Outcomes Computer System
  • PRO
  • Palliative Care
  • Symptoms
  • Questionnaire
  • Patients
  • Caregivers
  • Palliative Care Physicians
  • Palliative Care Nurses
03

In context

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Palliative care patients receiving care at University of Texas MD Anderson Cancer Center and their caregivers, physicians and nurses, all over the age of 21.

Inclusion criteria

  1. All patient/caregiver participants will be adults 21 years of age or older.
  2. Participants will be palliative care cancer patients and/or their designated caregivers.
  3. Participating patients should be receiving palliative care at the MD Anderson Cancer Center as an inpatient or have attended at least one outpatient appointment; participating caregivers should have provided care to their patient during an inpatient stay or have attended at least one outpatient appointment with their patient.
  4. Physicians and nurses who are experts in palliative care will be eligible for study participation. For this study's purposes, a physician or nurse with a minimum of four years of experience working in a palliative care setting will be considered an expert in palliative care.

Exclusion criteria

Exclusion Criteria:

  1. Patients or caregivers who are not able to report on symptom status using the electronic measurement system.
  2. Patient, caregivers, physicians, or nurses who do not agree to sign the study's informed consent documents.
05

Study design

Time perspective
Prospective
Enrollment
18 participants (actual)

Groups and cohorts

  • Patient

    Patient computer system use questionnaire

    Behavioral: Questionnaire and Review Session

  • Caregiver

    Caregiver computer system use questionnaire

    Behavioral: Questionnaire and Review Session

  • Healthcare Provider

    Physician and Nurse computer system use questionnaire

    Behavioral: Questionnaire and Review Session

Interventions

  • BehavioralQuestionnaire and Review Session

    Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete. Review session about use of computer system and suggested changes.

    Also known as: Survey, Computer Program

  • BehavioralQuestionnaire and Review Session

    Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete. Review session about use of computer system and suggested changes.

    Also known as: Survey, Computer Program

06

What researchers measure

Primary outcomes

  1. Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)

    Time frame: Single assessment point

07

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01024166
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Dec 2, 2009
Start date
Nov 2009
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Jun 7, 2013

Study contacts

Michael A. Kallen, PhD
study chair · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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