NCT01024166

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 7, 2013

Status Verified

June 1, 2013

Enrollment Period

2.6 years

First QC Date

November 30, 2009

Last Update Submit

June 6, 2013

Conditions

Keywords

CancerPatient-Reported Outcomes Computer SystemPROPalliative CareSymptomsQuestionnairePatientsCaregiversPalliative Care PhysiciansPalliative Care Nurses

Outcome Measures

Primary Outcomes (1)

  • Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)

    Single assessment point

Study Arms (3)

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

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
CaregiverPatient

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All patient/caregiver participants will be adults 21 years of age or older.
  • Participants will be palliative care cancer patients and/or their designated caregivers.
  • 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.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Michael A. Kallen, PhD

    UT MD Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

November 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 7, 2013

Record last verified: 2013-06

Locations