Unique ID issued by UMIN | UMIN000042443 |
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Receipt number | R000045593 |
Scientific Title | Psychological barriers of opioid analgesics and pain in patients with advanced recurrent cancer - A multicenter cohort study |
Date of disclosure of the study information | 2020/11/15 |
Last modified on | 2022/05/16 14:04:23 |
Psychological barriers of opioid analgesics and pain in patients
with advanced recurrent cancer - A multicenter cohort study
BAROC study
Psychological barriers of opioid analgesics and pain in patients
with advanced recurrent cancer - A multicenter cohort study
BAROC study
Japan |
advanced recurrent cancer
Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Oto-rhino-laryngology | Urology | Anesthesiology |
Malignancy
NO
To determine the presence of psychological resistance to strong opioid analgesics before and after the introduction of opioid analgesics in patients with advanced recurrent cancer, and the relationship between the speed with which pain improves and the dose of analgesic medication.
Pharmacodynamics
Confirmatory
Pragmatic
Not applicable
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.
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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
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
50
1st name | Ryota |
Middle name | |
Last name | Yanaizummi |
Yokohama City University Medical Center
Anesthesiology
232-0024
4-57, Urafune-cho, Minami-ku, Yokohama
0452615656
yanaizumi0330@yahoo.co.jp
1st name | Takehiko |
Middle name | |
Last name | Tsuno |
Yokohama City University Medical Center
Pharmacy
232-0024
4-57, Urafune-cho, Minami-ku, Yokohama
0452615656
take1201@yokohama-cu.ac.jp
Tokyo University of Pharmacy and Life Sciences
Self-funding
Self funding
YCU Center for Novel and Exploratory Clinical Trials
1-1-1, Fukuura, Kanazawa-ku, Yokohama
0453707933
rinri@yokohama-cu.ac.jp
NO
横浜市立大学附属市民総合医療センター(神奈川県)、国立がん研究センター東病院(千葉県)、東京医科大学病院(東京都)、横浜南共済病院(神奈川県)、亀田総合病院(千葉県)
2020 | Year | 11 | Month | 15 | Day |
Unpublished
Completed
2020 | Year | 05 | Month | 29 | Day |
2020 | Year | 08 | Month | 24 | Day |
2020 | Year | 11 | Month | 24 | Day |
2021 | Year | 12 | Month | 31 | Day |
2021 | Year | 12 | Month | 31 | Day |
Study type: Multicenter prospective observational study
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.
2020 | Year | 11 | Month | 13 | Day |
2022 | Year | 05 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045593
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