Pain Control in Hospice Patients With Cancer-Related Pain
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|ClinicalTrials.gov Identifier: NCT00609297|
Recruitment Status : Completed
First Posted : February 7, 2008
Last Update Posted : October 24, 2012
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|
- 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|
|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|
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 specifiedOther: questionnaire administration
The questionnaires will be completed at the end of week 1, week 2 and week 4.
Other Name: None SpecifiedOther: survey administration
Given to patient and caregivers throughout the study
Other Name: none specified
- Description of standard pain management methods and outcomes in the hospice setting [ Time Frame: date on study to death ]
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): NCT00609297
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Barbara A. Murphy, MD||Vanderbilt-Ingram Cancer Center|