UMIN-CTR Clinical Trial

Basic information
Public title	Psychological barriers of opioid analgesics and pain in patients with advanced recurrent cancer - A multicenter cohort study
Acronym	BAROC study
Scientific Title	Psychological barriers of opioid analgesics and pain in patients with advanced recurrent cancer - A multicenter cohort study
Scientific Title:Acronym	BAROC study
Region	Japan

Condition
Condition	advanced recurrent cancer
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Oto-rhino-laryngology Urology Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	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.
Key secondary outcomes	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.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Ryota Middle name Last name Yanaizummi
Organization	Yokohama City University Medical Center
Division name	Anesthesiology
Zip code	232-0024
Address	4-57, Urafune-cho, Minami-ku, Yokohama
TEL	0452615656
Email	yanaizumi0330@yahoo.co.jp

Public contact
Name of contact person	1st name Takehiko Middle name Last name Tsuno
Organization	Yokohama City University Medical Center
Division name	Pharmacy
Zip code	232-0024
Address	4-57, Urafune-cho, Minami-ku, Yokohama
TEL	0452615656
Homepage URL
Email	take1201@yokohama-cu.ac.jp

Sponsor
Institute	Tokyo University of Pharmacy and Life Sciences
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	YCU Center for Novel and Exploratory Clinical Trials
Address	1-1-1, Fukuura, Kanazawa-ku, Yokohama
Tel	0453707933
Email	rinri@yokohama-cu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	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）

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2020 Year 05 Month 29 Day
Date of IRB	2020 Year 08 Month 24 Day
Anticipated trial start date	2020 Year 11 Month 24 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	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.

Management information
Registered date	2020 Year 11 Month 13 Day
Last modified on	2022 Year 05 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045593