Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000262202
Ethics application status
Approved
Date submitted
1/02/2018
Date registered
20/02/2018
Date last updated
7/04/2024
Date data sharing statement initially provided
2/07/2019
Date results information initially provided
7/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessment of pain in patients with advanced cancer using physical activity monitor readings
Scientific title
Assessing physical activity as an outcome of pain management in patients with advanced cancer
Secondary ID [1] 293939 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Cancer 306427 0
Pain 306432 0
Condition category
Condition code
Cancer 305517 305517 0 0
Any cancer
Physical Medicine / Rehabilitation 305582 305582 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will receive an accelerometer which will be similar in size/design to a watch. Participants are to wear the monitor for the duration of the study for a total of 6 days. It will record a number of activities during this time like sleep, steps taken, body position etc. Participants will return to a scheduled clinic appointment on day 7 and return accelerometer and diaries collected during the 6 days. Nil follow-up regarding the trial is required, Participants will continue to see the doctor as per scheduled appointments.

Intervention code [1] 300245 0
Not applicable
Comparator / control treatment
The same intervention will be applied to all subject in the study. Subjects will be using a national rating scale scoring 0 - 10 for pain.
Control group
Active

Outcomes
Primary outcome [1] 304647 0
Assessing the feasibility of using tri-acclerometers in improving pain management and more accurate and meaningful measure of patient function and response to treatment Feasibility will be achieved if greater than or equal to 60% of participants wear the accelerometer for greater than or equal to 80% of the time during the 6 day trial period
Timepoint [1] 304647 0
Participant pain will be assessed from baseline to day 7. Participants will wear the tri-acclerometers for 6 days, Data will be collected from the tri-acclerometer. Nil follow on after this time
Secondary outcome [1] 342658 0
Correlation between physical function/activity and pain rated on numerical pain rating scale.
Activity output to be monitored - raw acceleration, physical activity intensity, total sleep time, activity counts, activity bouts, wake after sleep onset, energy expenditure, sedentary bouts, sleep efficiency, MET rates, body positions, steps taken, sleep latency, heart rate RR interval
Participants will be using the Edmonton Symptom Assessment System (ESAS) to rate pain on a scale, rating of 0(no pain) to 10(worst possible pain).
Timepoint [1] 342658 0
Participant pain will be assessed from baseline to day 7. Participants will wear the tri-acclerometers for 6 days to monitor physical activity/function, data will be collected from the tri-acclerometer. Nil follow on after this time

Eligibility
Key inclusion criteria
- Age > 18 years old
- Participants with advanced cancer who are patients at Mater Misericordiae Ltd or St Vincent's Private Hospital, Brisbane
- Who have an average pain score greater than or equal to 3 on numeric rating scale (NRS)
- Willing and able to comply with study requirements and provide written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The aim is to recruit 20 participants across the two sites over a 12 month recruitment period. Feasibility will be achieved if great than or equal to 60% of participants wear the accelerometer for greater than or equal to 80% of the time during the 6 day trial period. No specific sample size is needed to achieve this endpoint. Based on prior clinical trial experience, This will give an adequate sample size to define feasibility, provide sufficient numbers to detect a correlation of R equal 0.4 at power of 80% and alpha equal 0.05 between accelerometer data and pain score, as well as determine if this method could be used as the basis for future multi-centre studies with the ability to recruit adequate number of participants to answer clinically important research questions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2018
Actual
27/07/2018
Date of last participant enrolment
Anticipated
30/06/2020
Actual
18/05/2021
Date of last data collection
Anticipated
10/07/2020
Actual
25/05/2021
Sample size
Target
20
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9925 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [2] 9926 0
Mater Private Hospital - South Brisbane
Recruitment hospital [3] 9927 0
St Vincent's Hospital Brisbane - Kangaroo Point
Recruitment postcode(s) [1] 18737 0
4101 - South Brisbane
Recruitment postcode(s) [2] 18738 0
4169 - Kangaroo Point

Funding & Sponsors
Funding source category [1] 298566 0
Hospital
Name [1] 298566 0
Mater Misericordiae Ltd
Country [1] 298566 0
Australia
Primary sponsor type
Hospital
Name
Mater Misericordiae Ltd
Address
Raymond Terrace, South Brisbane, Qld 4101
Country
Australia
Secondary sponsor category [1] 297715 0
None
Name [1] 297715 0
Address [1] 297715 0
Country [1] 297715 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299533 0
Mater Misericordiae Lth Human Research Ethics Commitee (MML HREC)
Ethics committee address [1] 299533 0
Raymond Terrace, South Brisbane, Qld 4101
Ethics committee country [1] 299533 0
Australia
Date submitted for ethics approval [1] 299533 0
14/11/2017
Approval date [1] 299533 0
03/01/2018
Ethics approval number [1] 299533 0
HREC/17/MHS/131

Summary
Brief summary
This study will evaluate the effectiveness of using activity monitors to assess pain and physical activity in patients with advanced cancer.

Who is it for?
To be eligible for the study participants are to be over the age of 18 years, diagnosed with advanced cancer, are experiencing pain, and are patients at Mater Misericordaie Ltd or St Vincent's Private Hospital, Brisbane.

Study Details:
Participants will receive an tri- accelerometer which will be similar in size/design to a watch. Participants are to wear the monitor for the duration of the study for a total of 6 days. It will record a number of activities during this time like sleep, steps taken, body position etc. Participants will be required to keep a diary at home, where they are to complete daily pain score assessments. Participants are to return to a scheduled clinic appointment on day 7 and return tri-accelerometer and diaries. Nil follow-up regarding the trial is required; participants will continue to see the doctor as per scheduled appointments.

This research will help determine whether we may assess the effectiveness of pain management programs in an objective way. This in turn will allow us to determine which pain management methods are most effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80754 0
A/Prof Phillip Good
Address 80754 0
Mater Misericordiae Ltd, Raymond Terrace, South Brisbane, Qld 4101
Country 80754 0
Australia
Phone 80754 0
+617 3163 3884
Fax 80754 0
Email 80754 0
[email protected]
Contact person for public queries
Name 80755 0
Ms Georgie Cupples
Address 80755 0
Mater Misericordiae Ltd, Raymond Terrace, South Brisbane, Qld 4101
Country 80755 0
Australia
Phone 80755 0
+617 3163 3884
Fax 80755 0
Email 80755 0
[email protected]
Contact person for scientific queries
Name 80756 0
A/Prof Phillip Good
Address 80756 0
Mater Misericordiae Ltd, Raymond Terrace, South Brisbane, Qld 4101
Country 80756 0
Australia
Phone 80756 0
+617 3163 3884
Fax 80756 0
Email 80756 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://doi.org/10.1111/hex.13903 374424-(Uploaded-14-03-2024-13-03-27)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.