NCT00609297

Brief Summary

RATIONALE: Gathering information over time about cancer-related pain from patients in a hospice and their caregivers may help doctors learn more about pain control. PURPOSE: This clinical trial is studying how well standard pain control works in hospice patients with cancer-related pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 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

July 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 24, 2012

Status Verified

October 1, 2012

Enrollment Period

8 months

First QC Date

February 6, 2008

Last Update Submit

October 23, 2012

Conditions

PainSolid Tumor

Keywords

unspecified adult solid tumor, protocol specificpain

Outcome Measures

Primary Outcomes (1)

  • Description of standard pain management methods and outcomes in the hospice setting

    date on study to death

Study Arms (1)

Supportive Care

Alive Hospice Patients with Pain

Other: medical chart reviewOther: questionnaire administrationOther: survey administration

Interventions

medical chart reviewOTHER

The Research Nurse will conduct a chart review after the patient's death.

Also known as: None specified
Supportive Care
questionnaire administrationOTHER

The questionnaires will be completed at the end of week 1, week 2 and week 4.

Also known as: None Specified
Supportive Care
survey administrationOTHER

Given to patient and caregivers throughout the study

Also known as: none specified
Supportive Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Alive hospice who have pain and their caregivers.

You may qualify if:

  • Patient eligibility includes:
  • Alive Hospice outpatient
  • Diagnosis of carcinoma
  • Pain requiring fixed dose opioids
  • Age \> 21 years
  • Not pregnant or lactating
  • Willing and able to sign informed consent -Able to speak/comprehend English
  • Caregiver eligibility will include:
  • Caregiver for an Alive Hospice patient
  • Willing and able to sign informed consent
  • Able to speak/comprehend English

You may not qualify if:

  • PRIOR CONCURRENT THERAPY:
  • Not specified

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Barbara A. Murphy, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 7, 2008

Study Start

July 1, 2007

Primary Completion

March 1, 2008

Study Completion

May 1, 2011

Last Updated

October 24, 2012

Record last verified: 2012-10

Locations

US(1)