Psychological barriers of opioid analgesics and pain in patients with advanced recurrent cancer - A multicenter cohort study

Psychological barriers of opioid analgesics and pain in patients with advanced recurrent cancer - A multicenter cohort study - BAROC study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042443

Enrollment

Registered

2020-11-15

Start date

2020-11-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced recurrent cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with distant metastases or diagnosed with advanced recurrent cancer 2. Patients using strong opioid analgesics for cancer pain for the first time 3. Patients with most intense pain NRS (Numeric rating scale) of 4 or more in the past 24 hours 4. Patients with written consent to participate in the study

Exclusion criteria

Exclusion criteria: 1. Patients who are considered difficult to collect ePRO (e.g., do not have a smartphone or cannot use a tablet) 2. Patients who have cognitive problems that make it difficult to respond to PROs 3. Patients who have mental health issues that make it difficult to answer the PROs 4. Patients whose primary mechanism of pain is neuropathic pain 5. Patients deemed unfit by a physician

Design outcomes

Primary

Measure	Time frame
Total JBQ-II score, subscales: barriers related to physiological effects (distrust of symptomatic treatment), barriers related to fatalism (fatalistic resignation), barriers related to communication (disinclination), barriers related to harmful effects (fear of side effects), barriers related to disease progression (from disease We calculated the mean and point estimates of the scores of the (escape defense) scale, and estimated the 95% confidence intervals. In addition, we will classify all observations into groups using the PGI-S, which was installed as an anchor, and estimate the 95% confidence intervals by calculating the mean and point estimates of the total score and the score of the association scale in each group.	—

Measure

Time frame

Total JBQ-II score, subscales: barriers related to physiological effects (distrust of symptomatic treatment), barriers related to fatalism (fatalistic resignation), barriers related to communication (disinclination), barriers related to harmful effects (fear of side effects), barriers related to disease progression (from disease We calculated the mean and point estimates of the scores of the (escape defense) scale, and estimated the 95% confidence intervals. In addition, we will classify all observations into groups using the PGI-S, which was installed as an anchor, and estimate the 95% confidence intervals by calculating the mean and point estimates of the total score and the score of the association scale in each group.

—

Secondary

Measure	Time frame
Scores of JBQ-II for baseline, JBQ-II for Visit 2 and DRS Change in baseline and Visit 2 in JBQ-II scores Percentage of PPGs achieved through Day 7 The JBQ-II score or Anchor was used to classify the groups, and the differences in DRS score and PPG achievement rate between the two groups were estimated and tested.	—

Countries

Japan

Contacts

Public ContactTakehiko Tsuno

Yokohama City University Medical Center Pharmacy

take1201@yokohama-cu.ac.jp0452615656

Outcome results