Psychological barriers to the use of opioid analgesics for treating pain in patients with advanced recurrent cancer (BAROC): protocol for a multicentre cohort study

Abstract

IntroductionOpioid analgesics are essential for treating cancer pain. However, patients are sometimes reluctant to use them because of concerns about addiction and dependence. Rapid pain relief following opioid administration may help overcome the psychological barriers to opioid analgesic use. This study aims to determine the relationship between psychological resistance to strong opioid analgesic use and pain amelioration speed in patients with advanced recurrent cancer.Methods and analysisThis ongoing, multicentre, observational study enrols patients aged 20 years or older with distant metastasis or advanced recurrent cancer receiving strong opioid analgesics for cancer pain for the first time. All participants, both inpatient and outpatient, were recruited from five Japanese hospitals. We are investigating the relationship between psychological barriers at the start of treatment and pain relief during the first week of treatment in these patients. The primary outcome is the Japanese version of the Barriers Questionnaire-II score at baseline. The secondary outcomes are the relationships between psychological barriers to strong opioid analgesic use and changes in pain over time. The participants are asked to fill out an electronic patient-reported outcome daily during the first week of treatment. The sample size was determined based on the number of patients in the year prior to study commencement who used strong opioid analgesics, met the eligibility criteria and could be expected to consent to participate in the study.Ethics and disseminationThe study protocol was approved by the ethics committee (approval ID B200600091) of Yokohama City University on 24 August 2020. The protocol has been reviewed by the institutional review boards at the four participating study sites. The results will be published in a peer-reviewed journal and will be presented at a relevant meeting.Trial registration numberUMIN000042443.

Psychological barriers to the use of opioid analgesics for treating pain in patients with advanced recurrent cancer (BAROC): a multicenter cohort study

“…This was a multicenter, longitudinal, observational study. The eligibility criteria are described in a previously published protocol [12]. The main inclusion criterion was distant metastasis or advanced, recurrent cancer in patients who received strong opioid analgesics for cancer pain during their rst treatment.…”

“…Initially, the sample size was set at 200 [12]. However, after the study was initiated, there were di culties in collecting cases due to the number of eligible patients who were administered strong opioid analgesics decreased by 20% in 2020 as compared to the previous year, the di culty in obtaining consent due to general conditions at the time of administration, and the di culty in nding eligible patients with opioid prescriptions outside of palliative care outpatient clinics.…”