Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000591156
Ethics application status
Approved
Date submitted
10/04/2019
Date registered
17/04/2019
Date last updated
8/12/2021
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study that examines the feasibility of establishing a database that examines how genes affect opioid drug response in palliative care patients
Scientific title
A pilot feasibility study of establishing a clinical opioid pharmacogenomics database in palliative care
Secondary ID [1] 297940 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
OPPtiC
Linked study record
NIL

Health condition
Health condition(s) or problem(s) studied:
Pain 312329 0
Genomics 312330 0
Cancer 312339 0
Palliative Care 312340 0
Condition category
Condition code
Neurological 310893 310893 0 0
Other neurological disorders
Cancer 310919 310919 0 0
Any cancer
Human Genetics and Inherited Disorders 310921 310921 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The target group involves patients who require an opioid switch because of adverse effects or inadequate pain relief with the current opioid, as determined by clinician. Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity and opioid adverse effects. These measures will be completed on Day 0 and Day 7. A patient medication diary will be required between Day 0 to Day 7.
Intervention code [1] 314162 0
Not applicable
Comparator / control treatment
Patients who do not require an opioid switch, as determined by clinician. The target group involves patients who require an opioid switch because of adverse effects or inadequate pain relief with the current opioid, as determined by clinician. Participants will be required to have blood tests (for opioid pharmacokinetic and genomic analysis and biochemistry) and complete questionnaires relating to pain intensity and opioid adverse effects. These measures will be completed on Day 0 and Day 7. A patient medication diary will be required between Day 0 to Day 7.
Control group
Active

Outcomes
Primary outcome [1] 319716 0
At least 40% of eligible participants completing all study assessments
Timepoint [1] 319716 0
Day 0- Day 7
Primary outcome [2] 319719 0
The views of patients around the information and processes involved with data collection as measured by 30-minute one-on-one open-ended interview
Timepoint [2] 319719 0
Day 7
Primary outcome [3] 319742 0
The views of clinicians around the information and processes involved with data collection as measured by 30-minute one-on-one open-ended interview
Timepoint [3] 319742 0
Day 7
Secondary outcome [1] 369275 0
Change in pain severity as measured by participants completing the ESAS-CP
Timepoint [1] 369275 0
Day 0, Day 7
Secondary outcome [2] 369276 0
Presence of opioid adverse effect - nausea - as measured by SAS
Timepoint [2] 369276 0
Day 0, Day 7
Secondary outcome [3] 369278 0
Opioid levels as measured by plasma levels drawn from participant
Timepoint [3] 369278 0
Day 0, Day 7
Secondary outcome [4] 369279 0
Genomic analysis measured from blood DNA and RNA - exploratory outcome
Timepoint [4] 369279 0
Day 0, Day 7
Secondary outcome [5] 369280 0
Clinical Global Impression of Change as measured by GCI-C
Timepoint [5] 369280 0
Day 0, Day 7
Secondary outcome [6] 369290 0
Tiredness as measured by ESAS-R
Timepoint [6] 369290 0
Day 0, Day 7
Secondary outcome [7] 369370 0
Change in pain severity as measured by participants completing the BPI-SF
Timepoint [7] 369370 0
Day 0, Day 7
Secondary outcome [8] 369371 0
Change in breakthrough pain as measured by participants completing the adapted Alberta Breakthrough pain tool
Timepoint [8] 369371 0
Day 0, Day 7
Secondary outcome [9] 369372 0
Change in opioid dose as measured by patient medication diary consisting of opioid background and breakthrough doses
Timepoint [9] 369372 0
Days 0 to 7
Secondary outcome [10] 369373 0
Presence of opioid adverse effect - itch - as measured by SAS
Timepoint [10] 369373 0
Day 0, Day 7
Secondary outcome [11] 369374 0
Presence of opioid adverse effect - hallucinations - as measured by SAS
Timepoint [11] 369374 0
Day 0, Day 7
Secondary outcome [12] 369375 0
Presence of opioid adverse effect - hiccups - as measured by SAS
Timepoint [12] 369375 0
Day 0, Day 7
Secondary outcome [13] 369376 0
Presence of opioid adverse effect - delirium - as measured by NuDESC
Timepoint [13] 369376 0
Day 0, Day 7
Secondary outcome [14] 369377 0
Presence of opioid adverse effect - delirium - as measured by MDAS
Timepoint [14] 369377 0
Day 0, Day 7
Secondary outcome [15] 369441 0
Opioid metabolite levels (depending on which opioid is used) as measured by plasma levels drawn from participant
Timepoint [15] 369441 0
Day 0, Day 7
Secondary outcome [16] 369446 0
Drowsiness, as measured by ESAS-R
Timepoint [16] 369446 0
Day 0, Day 7
Secondary outcome [17] 369448 0
Shortness of breath, as measured by ESAS-R
Timepoint [17] 369448 0
Day 0, Day 7
Secondary outcome [18] 369450 0
Depression as measured by ESAS-R
Timepoint [18] 369450 0
Day 0, Day 7
Secondary outcome [19] 369451 0
Anxiety, as measured by ESAS-R
Timepoint [19] 369451 0
Day 0, Day 7
Secondary outcome [20] 369452 0
Overall wellbeing as measured by ESAS-R
Timepoint [20] 369452 0
Day 0, Day 7

Eligibility
Key inclusion criteria
Cancer diagnosis
Pain related to cancer and its treatment requiring opioid therapy
English speaking with sufficient reading and writing ability to complete the study questionnaires
Able and willing to give written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Australian-modified Karnofsky performance score (AKPS) less than 40 at the beginning of the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
All analyses will be conducted using descriptive statistics for those feasibility measures. The qualitative data will be analysed using a thematic approach with data coding according to question stems within the semi-structured interviews.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2019
Actual
18/04/2019
Date of last participant enrolment
Anticipated
28/06/2020
Actual
29/05/2020
Date of last data collection
Anticipated
1/11/2021
Actual
31/08/2021
Sample size
Target
50
Accrual to date
Final
57
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13603 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 13604 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 13605 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 13606 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [5] 13607 0
Western Hospital - Footscray - Footscray
Recruitment postcode(s) [1] 26265 0
3065 - Fitzroy
Recruitment postcode(s) [2] 26266 0
3000 - Melbourne
Recruitment postcode(s) [3] 26267 0
3050 - Parkville
Recruitment postcode(s) [4] 26268 0
3084 - Heidelberg
Recruitment postcode(s) [5] 26269 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 302345 0
Charities/Societies/Foundations
Name [1] 302345 0
Bethlehem Griffiths Research Foundation
Country [1] 302345 0
Australia
Funding source category [2] 302458 0
Hospital
Name [2] 302458 0
Research Endowment Fund, St Vincent’s Hospital, Melbourne
Country [2] 302458 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Hospital, Melbourne
Address
41 Victoria Parade, Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 302362 0
None
Name [1] 302362 0
Address [1] 302362 0
Country [1] 302362 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303019 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 303019 0
Ethics committee country [1] 303019 0
Australia
Date submitted for ethics approval [1] 303019 0
Approval date [1] 303019 0
21/01/2019
Ethics approval number [1] 303019 0
HREC 252/18

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

Contacts
Principal investigator
Name 92186 0
Prof Jennifer Philip
Address 92186 0
St Vincent’s Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065
Country 92186 0
Australia
Phone 92186 0
+61 03 9231 2211
Fax 92186 0
Email 92186 0
[email protected]
Contact person for public queries
Name 92187 0
Aaron Wong
Address 92187 0
PETER MACCALLUM CANCER CENTRE, 305 Grattan Street
Melbourne VIC 3000
Country 92187 0
Australia
Phone 92187 0
+61 (03) 8559 5000
Fax 92187 0
Email 92187 0
[email protected]
Contact person for scientific queries
Name 92188 0
Aaron Wong
Address 92188 0
PETER MACCALLUM CANCER CENTRE, 305 Grattan Street
Melbourne VIC 3000
Country 92188 0
Australia
Phone 92188 0
+61 (03) 8559 5000
Fax 92188 0
Email 92188 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
Confidentiality reasons


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
No additional documents have been identified.