Studying Different Doses of Opioids in Hospice Patients With Cancer-Related Pain

2014-08-27 03:18:14 | BioPortfolio


RATIONALE: Opioids lessen pain caused by cancer. Giving different doses of opioids in may give better pain relief. Gathering information about pain control from patients with cancer and their caregivers may help doctors improve patients' quality of life and help patients live more comfortably.

PURPOSE: This clinical trial is studying the side effects of different doses of opioids and to see how well they work in hospice patients with cancer-related pain.



- To determine the safety and feasibility of an oral opioid-titration order sheet in the hospice setting in patients with cancer-related pain.

OUTLINE: Patients receive oral opioid doses based on their expressed desire for an adjustment in their treatment regimen due to unsatisfactory pain control. Patients who express a desire for a modest increase in opioids receive a 25% increase in the 24-hour opioid total. Patients who express a desire for a significant increase in opioids receive a 50% increase in the 24-hour opioid total. Patients who feel that their dose of opioids is too high due to toxicity have a 25% decrease in opioid doses. Based on the severity of pain, patients are contacted every 24-72 hours for 4 weeks in order to determine whether their pain regimen is satisfactory.

Data regarding pain and pain management are obtained from three sources: the patient, the caregiver, and the medical records.

- Patient assessment: At baseline, patients provide demographic data and complete the Pain Assessment Form and the Pain Communication Survey. The pain assessment 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 healthcare providers about their pain. After the baseline assessment is completed, patients complete the Pain Assessment form on a daily basis. Pain is also assessed by the research nurse at least 3 times weekly (1 home visit* and 2 telephone interviews). Patients are followed until the time of death.

NOTE: *If a patient is hospitalized or transferred to the inpatient hospice facility, the patient interview will take place there.

- Caregiver assessment: At baseline, caregivers complete a demographic survey, a Pain Assessment Form, the Pain Communication Survey, Caregiver Self-Efficacy in Pain Management Scale (CSEPMS), 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 to obtain more detailed information about adequacy of the patient's pain control, side effects of medication, barriers to pain control, and caregiver concerns and burden. Follow-up data from caregivers is obtained through completion of CSEPMS, CPMQ, and SCARED questionnaires and their assessment of patient's pain form at the end of weeks 1, 2, and 3.

- Chart review: A research nurse conducts a chart review after patient's death. Cancer and cancer-related treatment data is 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 physician or other support personnel (including pharmacy calls), identified barriers to pain control, and treatment modifications (including medications to treat side effects).

Study Design

Masking: Open Label, Primary Purpose: Supportive Care




telephone-based intervention, communication intervention, intervention by caregiver, medical chart review, questionnaire administration, survey administration, end-of-life treatment/management, pain therapy, psychosocial assessment and care




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:18:14-0400

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