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Trial registered on ANZCTR
Registration number
ACTRN12618000398202
Ethics application status
Approved
Date submitted
5/03/2018
Date registered
20/03/2018
Date last updated
16/11/2023
Date data sharing statement initially provided
16/11/2023
Date results information initially provided
16/11/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Patient Reported Outcomes in the Medical Oncology Setting (iPROMOS)
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Scientific title
Implementing Patient Reported Outcomes (PROs) in the Medical Oncology Setting: A stepped wedge study to implement PROs into the clinical practice of the medical oncology outpatients department
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Secondary ID [1]
294210
0
nil known
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Universal Trial Number (UTN)
U1111-1210-1614
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Trial acronym
iPROMOS
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Linked study record
none
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Health condition
Health condition(s) or problem(s) studied:
cancer
306860
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Condition category
Condition code
Cancer
305956
305956
0
0
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Any cancer
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Public Health
305957
305957
0
0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
When patients attend the allocated clinic they will be approached to report their symptoms via a touchscreen computer. The PROM chosen is the CTCAE-PRO that Basch et al (2016) used in their clinical trial. A report will be printed, and a copy will be given to the patient and a copy put into their medical record.
The intervention will be monitored by completion rates and response rates of clinicians.
Basch et al (2016). JCO 30(34), 4249-4255.
The study will be facilitated by an oncology nurse with more than 5 years experience.
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Intervention code [1]
300500
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Other interventions
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Comparator / control treatment
Control is usual care. There are currently no guidelines in place for capturing this information from patients. Commonly CTCAE grading will be used according to individual clinician practice.
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Control group
Active
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Outcomes
Primary outcome [1]
304997
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Successful implementation as defined as, 1) PRO reports made available in the medical record to staff as per protocol in 90% of patient encounters, 2) 75% of clinicians responding to PRO data, and 3) of those, 50% of responses to PRO data noted in the medical record
This data will be assessed from metrics in the REDCap database, from Case Report Forms completed by clinicians and review of medical records
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Assessment method [1]
304997
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Timepoint [1]
304997
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90 days post intervention commencement
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Secondary outcome [1]
343835
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Objective outcome measures to be assessed by review of medical records including hospital admissions and emergency room presentations.
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Assessment method [1]
343835
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Timepoint [1]
343835
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Day 90 post intervention commencement
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Secondary outcome [2]
344158
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Survival as assessed by medical record review
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Assessment method [2]
344158
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Timepoint [2]
344158
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90 days and 12 months post commencement of intervention.
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Eligibility
Key inclusion criteria
1. patients attending for medical review in randomized medical oncology outpatient clinics
2. Staff caring for the patients attending the randomized medical oncology outpatient clinics
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Difficulty completing or understanding the PRO forms including significant cognitive impairment, visual difficulties or non-English speaking background
2. Staff that are not willing to participate
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization procedure
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Stepped wedge/cluster randomisation
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics and a sample size calculation has been done
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
21/03/2018
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Actual
21/03/2018
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Date of last participant enrolment
Anticipated
19/06/2018
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Actual
19/06/2018
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Date of last data collection
Anticipated
19/06/2019
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Actual
19/06/2019
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Sample size
Target
500
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Accrual to date
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Final
461
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
10247
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Royal Brisbane & Womens Hospital - Herston
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Recruitment postcode(s) [1]
21912
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4029 - Herston
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Funding & Sponsors
Funding source category [1]
298847
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Charities/Societies/Foundations
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Name [1]
298847
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Royal Brisbane and Women's Hospital Foundation
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Address [1]
298847
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Royal Brisbane and Women's Hospital,
Butterfield St,
Herston, QLD, 4029
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Country [1]
298847
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Australia
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Primary sponsor type
Individual
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Name
Natasha Roberts
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Address
Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
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Country
Australia
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Secondary sponsor category [1]
298130
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University
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Name [1]
298130
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Queensland University of Technology
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Address [1]
298130
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Musk Avenue,
Kelvin Grove,
Queensland, 4029
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Country [1]
298130
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
299791
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Royal Brisbane and Women's Hospital HREC
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Ethics committee address [1]
299791
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Royal Brisbane and Women's Hospital,
Butterfield St,
Herston, QLD, 4029
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Ethics committee country [1]
299791
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Australia
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Date submitted for ethics approval [1]
299791
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17/08/2017
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Approval date [1]
299791
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05/12/2017
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Ethics approval number [1]
299791
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REC/17/QRBW/416
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Ethics committee name [2]
299818
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Queensland University of Technology
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Ethics committee address [2]
299818
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Musk Ave,
Kelvin Grove, QLD, 4059
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Ethics committee country [2]
299818
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Australia
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Date submitted for ethics approval [2]
299818
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11/12/2017
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Approval date [2]
299818
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21/12/2017
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Ethics approval number [2]
299818
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HREC/17/QRBW/416
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Summary
Brief summary
Strong evidence published in 2016 showed that routine collection of Patient Reported Outcomes (PROs) significantly improves the survival and quality of life of medical oncology patients in the US and Europe (Basch, 2016). Despite these findings, PROs are not routinely used in Australian oncology care. The purpose of this translational research project is to understand how PROs can be implemented in a medical oncology setting to improve personalized care.The purpose of this project is to explore the feasibility, acceptance and effectiveness of implementing Patient Reported Outcomes (PRO) measurement in routine medical oncology outpatient care.
Who is it for?
You may be eligible for this study if you are over the age of 18 and are a patient attending for medical review in a medical oncology clinic enrolled in the study.
Study details
All patients attending the enrolled clinics will be approached to report their symptoms on a touchscreen, which will generate a report. A copy of the report will be given to participants, and a copy put in the patients medical record. This information will be available to all clinicians in the multidisciplinary team. The study will be facilitated and evaluated using an implementation science approach throughout.
It is hope that results from this study will provide evidence and guide future research into the implementation of this complex intervention into the clinical setting. There are significant benefits in the clinical trials to date, and it is hoped that this project can better inform the translation of this into clinical practice.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Natasha Roberts
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Address
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Ground floor,
Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD 4029
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Country
81578
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Australia
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Phone
81578
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+61 7 3647 0350
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Fax
81578
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+61 7 3646 7371
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Email
81578
0
[email protected]
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Contact person for public queries
Name
81579
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Ms Natasha Roberts
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Address
81579
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Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
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Country
81579
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Australia
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Phone
81579
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+61 7 3647 0350
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Fax
81579
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+61 7 3646 7371
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Email
81579
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[email protected]
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Contact person for scientific queries
Name
81580
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Ms Natasha Roberts
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Address
81580
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Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
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Country
81580
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Australia
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Phone
81580
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+61 7 3647 0370
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Fax
81580
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+61 7 3646 7371
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Email
81580
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
20939
Study protocol
https://bmjopen.bmj.com/content/9/2/e027046
20940
Ethical approval
https://bmjopen.bmj.com/content/9/2/e027046
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.
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