Trial Review

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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)
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
Secondary ID [1] 294210 0
nil known
Universal Trial Number (UTN)
U1111-1210-1614
Trial acronym
iPROMOS
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
cancer 306860 0
Condition category
Condition code
Cancer 305956 305956 0 0
Any cancer
Public Health 305957 305957 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 300500 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 304997 0
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
Timepoint [1] 304997 0
90 days post intervention commencement
Secondary outcome [1] 343835 0
Objective outcome measures to be assessed by review of medical records including hospital admissions and emergency room presentations.
Timepoint [1] 343835 0
Day 90 post intervention commencement
Secondary outcome [2] 344158 0
Survival as assessed by medical record review
Timepoint [2] 344158 0
90 days and 12 months post commencement of intervention.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization procedure
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge/cluster randomisation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics and a sample size calculation has been done

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/03/2018
Actual
21/03/2018
Date of last participant enrolment
Anticipated
19/06/2018
Actual
19/06/2018
Date of last data collection
Anticipated
19/06/2019
Actual
19/06/2019
Sample size
Target
500
Accrual to date
Final
461
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 10247 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 21912 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 298847 0
Charities/Societies/Foundations
Name [1] 298847 0
Royal Brisbane and Women's Hospital Foundation
Country [1] 298847 0
Australia
Primary sponsor type
Individual
Name
Natasha Roberts
Address
Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
Country
Australia
Secondary sponsor category [1] 298130 0
University
Name [1] 298130 0
Queensland University of Technology
Address [1] 298130 0
Musk Avenue,
Kelvin Grove,
Queensland, 4029
Country [1] 298130 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299791 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 299791 0
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston, QLD, 4029
Ethics committee country [1] 299791 0
Australia
Date submitted for ethics approval [1] 299791 0
17/08/2017
Approval date [1] 299791 0
05/12/2017
Ethics approval number [1] 299791 0
REC/17/QRBW/416
Ethics committee name [2] 299818 0
Queensland University of Technology
Ethics committee address [2] 299818 0
Musk Ave,
Kelvin Grove, QLD, 4059
Ethics committee country [2] 299818 0
Australia
Date submitted for ethics approval [2] 299818 0
11/12/2017
Approval date [2] 299818 0
21/12/2017
Ethics approval number [2] 299818 0
HREC/17/QRBW/416

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81578 0
Ms Natasha Roberts
Address 81578 0
Ground floor,
Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD 4029
Country 81578 0
Australia
Phone 81578 0
+61 7 3647 0350
Fax 81578 0
+61 7 3646 7371
Email 81578 0
natasha.roberts@health.qld.gov.au
Contact person for public queries
Name 81579 0
Ms Natasha Roberts
Address 81579 0
Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
Country 81579 0
Australia
Phone 81579 0
+61 7 3647 0350
Fax 81579 0
+61 7 3646 7371
Email 81579 0
natasha.roberts@health.qld.gov.au
Contact person for scientific queries
Name 81580 0
Ms Natasha Roberts
Address 81580 0
Ground Floor, Building 34,
Royal Brisbane and Women's Hospital,
Butterfield St,
Herston,
QLD, 4029
Country 81580 0
Australia
Phone 81580 0
+61 7 3647 0370
Fax 81580 0
+61 7 3646 7371
Email 81580 0
natasha.roberts@health.qld.gov.au

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20939Study protocolhttps://bmjopen.bmj.com/content/9/2/e027046  
20940Ethical approvalhttps://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.