Pain Control in Hospice Patients With Cancer-Related Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Opioid Titration in the Hospice Setting: Barriers Assessment and Modification of the Model Order Sheet and Protocol Stage 2, Part A

Conditions
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Pain, Solid Tumor

Intervention / Treatment
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* Other: medical chart review
* Other: questionnaire administration
* Other: survey administration


Participation Criteria
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Eligibility Criteria
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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: PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Supportive Care<br>Alive Hospice Patients with Pain | Other: medical chart review<br>* The Research Nurse will conduct a chart review after the patient's death.<br>* Other names: None specified;Other: questionnaire administration<br>* The questionnaires will be completed at the end of week 1, week 2 and week 4.<br>* Other names: None Specified;Other: survey administration<br>* Given to patient and caregivers throughout the study<br>* Other names: none specified;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of standard pain management methods and outcomes in the hospice setting |  | date on study to death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, pain