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Trial registered on ANZCTR


Registration number
ACTRN12619001126101
Ethics application status
Approved
Date submitted
18/07/2019
Date registered
12/08/2019
Date last updated
20/01/2020
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PROpatient: Can symptom monitoring and care coordination improve the quality of life of people with upper gastrointestinal cancer.
Scientific title
PROpatient: A registry-based randomised controlled trial of symptom monitoring, using patient-reported outcomes, and care coordination integrated into clinical practice to improve quality of life for people with upper gastrointestinal cancer.
Secondary ID [1] 298778 0
ICOUGI18008
Universal Trial Number (UTN)
U1111-1234-5584
Trial acronym
PROpatient
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pancreatic cancer 313723 0
esophageal cancer 313724 0
gastric cancer 313725 0
Condition category
Condition code
Cancer 312134 312134 0 0
Pancreatic
Cancer 312135 312135 0 0
Oesophageal (gullet)
Cancer 312136 312136 0 0
Stomach

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PROpatient intervention involves the frequent monitoring of disease-specific symptoms. Data is collected from the participant’s personal smart phone, tablet or computer, at any time, and as frequently as required. The total duration of the intervention is up to 12 months.
The electronic 'symptom monitoring tool' is a questionnaire, developed by a team clinicians and expert researchers in the field of patient-reported outcomes (PROs). It consists of a series of symptom-based questions, with a 0-10 scale, taking a maximum of 20 minutes to complete. Participants will be prompted to complete the symptom monitoring tool by SMS or email every two weeks, if no responses have been received during the previous two week period.
The IT platform used to collect the data will integrate it into a dashboard with participants reporting severe or worsening symptoms (according to an escalation policy) being flagged. Project-based cancer care coordinators will have access to the dashboard, triage and contact flagged participants within 1-2 business days, and, if relevant, refer them to the appropriate site-specific health services and/or professionals (according to the site-specific decision support guide). Evidence-based self-management guides and resources will be provided in real-time to participants reporting mild or moderate symptoms (according to an escalation policy) upon each completion of the symptom monitoring tool. Patient-level reports will be provided to treating clinicians in real-time, via an email link through the IT platform, highlighting severe and/or worsening symptoms.
Participants in the intervention arm will also complete the EORTC QLQ C30 and PINQ questionnaires at baseline, 3 months, 6 months and 12 months post-randomisation.
Intervention code [1] 315047 0
Other interventions
Comparator / control treatment
The control treatment is usual care, with patients receiving routine care for treatment of pancreatic and oesophagogastric cancer as determined by individual site health care providers. Participants allocated to this arm will also be completing the EORTC QLQ C3O and PINQ questionnaires at baseline,3 months, 6 months and 12 months post-randomisation.
Control group
Active

Outcomes
Primary outcome [1] 320771 0
A 10-unit change in health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30).
Timepoint [1] 320771 0
Baseline, 3 months, 6 months (primary timepoint) and 12 months after randomisation.
Secondary outcome [1] 372791 0
Change in patient information needs assessed using the Patient Informational Needs Questionnaire (PINQ).
Timepoint [1] 372791 0
At 3 months, 6 months and 12 months after randomisation.
Secondary outcome [2] 372792 0
Health service utilisation as assessed by data linkage to Medicare Benefits Scheme (MBS), Pharmaceutical Benefits Scheme (PBS) and the Victorian Admitted Episodes Dataset (VAED).
Timepoint [2] 372792 0
At 3 months, 6 months and 12 months after randomisation.
Secondary outcome [3] 372793 0
Number of emergency department visits as assessed by data linkage to the Victorian Emergency Minimum Dataset (VAED).
Timepoint [3] 372793 0
At 3 months, 6 months and 12 months after randomisation.
Secondary outcome [4] 372794 0
Median survival as assessed by data linkage to the Upper Gastrointestinal Cancer Registry (UGICR).
Timepoint [4] 372794 0
At 12 months after randomisation.
Secondary outcome [5] 372795 0
Referral to palliative care as assessed by data linkage to the Upper Gastrointestinal Cancer Registry (UGICR).
Timepoint [5] 372795 0
At 3 months, 6 months and 12 months after randomisation.

Eligibility
Key inclusion criteria
Patients participating in the Upper Gastrointestinal Cancer Registry, who are newly diagnosed (up to 3 months post-diagnosis) with pancreatic, oesophageal and gastric cancer that are diagnosed, managed or treated at one of the participating trial sites.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who do not meet the inclusion criteria, require an interpreter (non-English speaking), or without the capacity to give informed consent (suffering from dementia, delirium or confusion), will be excluded from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment via central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Stratification factors include: hospital site and tumour type
Block sizes 2 & 4
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be summarised by mean, standard deviation, minimum, median, and maximum. Categorical variables will be summarised by counts and percentages. For the primary quality of life analysis, mean QOL scores (global health/QOL scale) for participants in each study arm will be calculated at 6 months and compared with baseline scores, excluding those who did not complete any post-baseline EORTC-QLQ-C30 questionnaire. The proportion of patients in each arm who experienced improved, unchanged, or worsened scores from baseline will be compared using Fisher’s exact test. This analysis will be conducted both for any level of change from baseline and for a 10-point change from baseline. The 10-point improvement is based on expert opinion on the level of impact which would be considered clinically important. All analysis will be performed at the 5% level of significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2020
Actual
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
246
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14278 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 14279 0
The Alfred - Prahran
Recruitment hospital [3] 14280 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 14281 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [5] 14282 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment hospital [6] 14283 0
Ballarat Health Services - Queen Elizabeth Centre - Ballarat
Recruitment hospital [7] 14286 0
Box Hill Hospital - Box Hill
Recruitment hospital [8] 14287 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [9] 14288 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [10] 14289 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [11] 14290 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [12] 14291 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [13] 15633 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [14] 15634 0
Cabrini Hospital - Prahran - Prahran East
Recruitment hospital [15] 15635 0
Cabrini Brighton - Brighton
Recruitment postcode(s) [1] 27274 0
3084 - Heidelberg
Recruitment postcode(s) [2] 27275 0
3004 - Prahran
Recruitment postcode(s) [3] 27276 0
3168 - Clayton
Recruitment postcode(s) [4] 27277 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 27278 0
3350 - Ballarat Central
Recruitment postcode(s) [6] 27279 0
3350 - Ballarat
Recruitment postcode(s) [7] 27282 0
3128 - Box Hill
Recruitment postcode(s) [8] 27283 0
3000 - Melbourne
Recruitment postcode(s) [9] 27284 0
3050 - Parkville
Recruitment postcode(s) [10] 27285 0
3065 - Fitzroy
Recruitment postcode(s) [11] 29042 0
3144 - Malvern
Recruitment postcode(s) [12] 29043 0
3181 - Prahran East
Recruitment postcode(s) [13] 29044 0
3186 - Brighton

Funding & Sponsors
Funding source category [1] 303335 0
Government body
Name [1] 303335 0
Victorian Cancer Agency
Country [1] 303335 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 303361 0
None
Name [1] 303361 0
Address [1] 303361 0
Country [1] 303361 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303864 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 303864 0
Ethics committee country [1] 303864 0
Australia
Date submitted for ethics approval [1] 303864 0
21/08/2019
Approval date [1] 303864 0
16/09/2019
Ethics approval number [1] 303864 0

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

Contacts
Principal investigator
Name 95066 0
Prof John Zalcberg
Address 95066 0
School of Public Health and Preventive Medicine
Level 2, 553 St Kilda Rd.
Melbourne, VIC
Australia
Monash University


Country 95066 0
Australia
Phone 95066 0
+61399030388
Fax 95066 0
Email 95066 0
john.zalcberg@monash.edu
Contact person for public queries
Name 95067 0
Liane Ioannou
Address 95067 0
School of Public Health and Preventive Medicine
Level 2, 553 St Kilda Rd.
Melbourne, VIC
Australia
Monash University
Country 95067 0
Australia
Phone 95067 0
+61399030046
Fax 95067 0
Email 95067 0
liane.ioannou@monash.edu
Contact person for scientific queries
Name 95068 0
Liane Ioannou
Address 95068 0
School of Public Health and Preventive Medicine
Level 2, 553 St Kilda Rd.
Melbourne, VIC
Australia
Monash University
Country 95068 0
Australia
Phone 95068 0
+61399030046
Fax 95068 0
Email 95068 0
liane.ioannou@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual participant data (IPD) will not be made publicly available due to registry ethics and privacy restrictions.


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.