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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00878267
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : September 21, 2011
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Advanced Cancer Behavioral: Interview

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Qualitative Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
Study Start Date : March 2009
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hospice Care
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878267


Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michael A. Kallen, PhD UT MD Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00878267     History of Changes
Other Study ID Numbers: 2008-0840
First Posted: April 8, 2009    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

Keywords provided by M.D. Anderson Cancer Center:
Cancer
Computer Program
Palliative Care
Patient-Reported Outcomes
PRO
Palliative and Hospice Care Practice
Electronic Health Record
EHR
Interview