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Trial registered on ANZCTR


Registration number
ACTRN12622000853741
Ethics application status
Approved
Date submitted
5/06/2022
Date registered
16/06/2022
Date last updated
16/06/2022
Date data sharing statement initially provided
16/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of Edmonton Classification System for Cancer Pain in Patients with Bone Metastasis: a cohort study
Scientific title
The Edmonton Classification System for Cancer Pain in Patients with Bone Metastasis: A descriptive cohort study
Secondary ID [1] 307285 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bone metastasis 326566 0
Condition category
Condition code
Cancer 323848 323848 0 0
Any cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study involves a single cross-sectional survey of cancer patients with bone metastasis to assess the five different components of the Edmonton Classification System for Cancer Pain (ECSCP):pain mechanism, incident pain, addictive behaviour, psychological distress and cognitive impairment. Each survey will take an average of 1-hour to complete. Pain mechanism was determined clinically by palliative care physician/specialist through a face-face or telehealth history and/or examination. Incident pain was documented using the Breakthrough pain assessment tool (BAT). Evidence of addictive behaviour was considered present if a patient score one or greater using the Cut down, Annoyed, Guilty and Eye-opener questionnaire adapted to include drugs (CAGE-AID). Cognitive function was assessed using the Short Orientation Memory Concentration Test (SOMCT) with score of 0-8: normal-minimum, 9-19: minimal to moderate and 20-28: severe cognitive impairment. Psychological distress was determined as present when scored four or greater using the Distress Thermometer (score range from 0-10).

In addition to the ECS-CP features above, pain intensity scores were measured using the 11-point numeric rating scale with 0 representing no pain and 10 representing worse pain imaginable. Pharmacological pain management, including background opioid in oral morphine equivalent daily dose (OMEDD) and daily frequency of breakthrough opioid analgesia requirement were obtained from the participants directly or through the inpatient electronic Medication Management chart.
Intervention code [1] 323729 0
Early Detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331604 0
Pain intensity assessed using an 11-point numeric rating scale
Timepoint [1] 331604 0
Once only at the time of enrolment
Primary outcome [2] 331660 0
Incident pain - typical duration using the Breakthrough pain assessment tool (BAT)
Timepoint [2] 331660 0
once only at time of enrolment
Primary outcome [3] 331661 0
incident pain - average daily frequency in the last week using the Breakthrough pain assessment tool (BAT)
Timepoint [3] 331661 0
once only at time of enrolment
Secondary outcome [1] 410458 0
Addictive behaviour assessed using the Cut down, Annoyed, Guilty and Eye-opener questionnaire adapted to include drugs (CAGE-AID)
Timepoint [1] 410458 0
Once only at the time of enrolment
Secondary outcome [2] 410459 0
Cognitive function assessed using the Short Orientation Memory Concentration Test (SOMCT)
Timepoint [2] 410459 0
Once only at the time of enrolment
Secondary outcome [3] 410460 0
Psychological distress using the distress thermometer
Timepoint [3] 410460 0
Once only at the time of enrolment
Secondary outcome [4] 410653 0
pain mechanism as assessed by palliative care physician on history and/ or physical examination
Timepoint [4] 410653 0
once only at the time of enrolment
Secondary outcome [5] 410654 0
Background oral morphine equivalent daily dose by review of medication charts, participant self-report
Timepoint [5] 410654 0
once only at the time of enrolment
Secondary outcome [6] 410655 0
average daily breakthrough opioid frequency in last 72 hours by review of medication charts, participant self-report
Timepoint [6] 410655 0
once only at the time of enrolment

Eligibility
Key inclusion criteria
(a) adults >/=18 years of age with a diagnosis of solid tumour or haematological malignancy, (b) confirmation of bone metastasis on imaging
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to complete clinical assessment due to (a) language barrier, (b) significant cognitive impairment or mental health condition, and (c) too unwell to participate in the study as determined by the patient’s treating physician.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Patient demographics and pain characteristics were described using proportions for categorical variables, means and standard deviations (SDs) or medians and inter-quartile ranges (IQRs) as appropriate for continuous data distribution. Correlation between each and sum of negative ECS-CP features and pain intensity, breakthrough pain characteristics and opioid requirements were analysed. Independent sample t-test was performed to assess the association between each EC-SCP feature, pain intensity and opioid requirements. Multivariable regression analysis was used to analyse the relationship between ECSS-CP composite score and pain intensity. A two-tailed p value <0.05 indicated statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/01/2021
Date of last participant enrolment
Anticipated
Actual
21/02/2022
Date of last data collection
Anticipated
Actual
21/02/2022
Sample size
Target
150
Accrual to date
Final
140
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22489 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 22490 0
Cabrini Hospital - Prahran - Prahran East
Recruitment postcode(s) [1] 37724 0
3144 - Malvern
Recruitment postcode(s) [2] 37725 0
3181 - Prahran East

Funding & Sponsors
Funding source category [1] 311581 0
Other Collaborative groups
Name [1] 311581 0
Cabrini Institute
Country [1] 311581 0
Australia
Primary sponsor type
Individual
Name
Dr Merlina Sulistio
Address
Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran
VIC 3181
Country
Australia
Secondary sponsor category [1] 313018 0
Individual
Name [1] 313018 0
A/prof Natasha Michael
Address [1] 313018 0
Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran
VIC 3181
Country [1] 313018 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311030 0
Cabrini Research Governance Office
Ethics committee address [1] 311030 0
Ethics committee country [1] 311030 0
Australia
Date submitted for ethics approval [1] 311030 0
31/12/2020
Approval date [1] 311030 0
07/01/2021
Ethics approval number [1] 311030 0
04-04-02-21

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119750 0
Dr Merlina Sulistio
Address 119750 0
Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran VIC 3181
Country 119750 0
Australia
Phone 119750 0
+61433502901
Fax 119750 0
Email 119750 0
msulistio@cabrini.com.au
Contact person for public queries
Name 119751 0
Merlina Sulistio
Address 119751 0
Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran VIC 3181
Country 119751 0
Australia
Phone 119751 0
+61 395085027
Fax 119751 0
Email 119751 0
msulistio@cabrini.com.au
Contact person for scientific queries
Name 119752 0
Merlina Sulistio
Address 119752 0
Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran VIC 3181
Country 119752 0
Australia
Phone 119752 0
+61 395085027
Fax 119752 0
Email 119752 0
msulistio@cabrini.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of individual deidentified data of trial participants
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator
email: msulistio@cabrini.com.au
Add: Cabrini Supportive, Psychosocial and Palliative Care Research Department
646 High St Prahran VIC 3181 Australia


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Edmonton Classification System for Cancer Pain in Patients with Bone Metastasis: a descriptive cohort study.2023https://dx.doi.org/10.1007/s00520-023-07711-9
N.B. These documents automatically identified may not have been verified by the study sponsor.