Pain Control in Hospice Patients With Cancer-Related Pain

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. Identifier: NCT00609297
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 24, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment
Pain Solid Tumor Other: medical chart review Other: questionnaire administration Other: survey administration

Detailed Description:


  • To obtain prospective data describing standard pain management methods and outcomes in the hospice setting.

OUTLINE: Data regarding pain and pain management is obtained from three sources: the patient, the caregiver(s), and the medical records.

  • Patient assessment*: At baseline, patients provide demographic data and complete the Pain Assessment Form verbally via interview. The form addresses average pain, worst pain, pain relief, hours in pain, pain-related distress, and barriers to pain control. Patients are asked to rate pain control. Patients also complete the Pain Communication Survey to assess how they communicate with health care providers about their pain. After the baseline assessment is completed, pain is assessed by the research nurse through home visits* 3 times weekly and telephone interviews twice weekly. During each visit or telephone contact, patients are interviewed to complete the Pain Assessment Form. Patients are followed until the time of death.

NOTE: *If a patient is not available for the scheduled home visit, the interview will take place over the phone; if a patient is hospitalized or transferred to the inpatient hospice facility, the patient interview will take place there.

  • Primary caregiver assessment**: At baseline, primary caregivers complete a demographic survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain Management Scale (CSEPMS), the Caregiver Pain Management Questionnaire (CPMQ), and the Stressful Caregiver Adult Reactions to Experiences of Dying (SCARED). Caregivers are then interviewed by the study nurse using the Pain Assessment Form as a guideline. Follow-up data from caregivers is obtained through a daily diary, interviews, and structured surveys. Primary caregivers complete the Pain Assessment Form daily and are instructed to provide their assessment of the patient's pain. In addition, caregivers are interviewed daily by a study nurse, who reviews the daily Pain Assessment Form and obtains detailed information regarding the adequacy of patient pain control, side effects of medication, barriers to pain control, and caregiver concerns and burdens. Primary caregivers also complete CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4 as part of follow-up. Primary caregivers are contacted after the patient's death to assess pain control at the time of death.
  • Secondary caregiver assessment: At baseline, secondary caregivers complete the same baseline evaluation as primary caregivers over the phone. They complete the Pain Assessment Form weekly and the CSEPMS, CPMQ, and SCARED questionnaires at the end of weeks 1, 2, and 4. Secondary caregivers also undergo a post-mortem interview based on the Pain Assessment Form.
  • Chart review: Chart review is conducted by the research Nurse after a patient's death. Cancer and cancer-related treatment are obtained and documentation about pain management is recorded. From the time of study entry, all staff notes are reviewed to document: pain assessment, calls to physicians or other support personnel (including pharmacy calls), identified barriers to pain control, and treatment modifications (including medications to treat side effects).

NOTE: **Patients and primary caregivers are interviewed independently.

Study Type : Observational
Actual Enrollment : 22 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part A
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
Supportive Care
Alive Hospice Patients with Pain
Other: medical chart review
The Research Nurse will conduct a chart review after the patient's death.
Other Name: None specified
Other: questionnaire administration
The questionnaires will be completed at the end of week 1, week 2 and week 4.
Other Name: None Specified
Other: survey administration
Given to patient and caregivers throughout the study
Other Name: none specified

Primary Outcome Measures :
  1. Description of standard pain management methods and outcomes in the hospice setting [ Time Frame: date on study to death ]

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
Patients in Alive hospice who have pain and their caregivers.

Inclusion Criteria:

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

Exclusion Criteria:


  • Not specified

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 identifier (NCT number): NCT00609297

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Barbara A. Murphy, MD Vanderbilt-Ingram Cancer Center

Responsible Party: Barbara Murphy, MD, Professor of Medicine, Vanderbilt-Ingram Cancer Center Identifier: NCT00609297     History of Changes
Other Study ID Numbers: VICC SUPP 0731
First Posted: February 7, 2008    Key Record Dates
Last Update Posted: October 24, 2012
Last Verified: October 2012

Keywords provided by Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center:
unspecified adult solid tumor, protocol specific