A registry-based randomised controlled trial of symptom monitoring for patients with upper gastrointestinal cancer.
Newsletter #2 - April 2020 

       Newsletter Overview 

  • COVID-19 & PROpatient 
  • What we've been up to...
  • Our new resource development sub-study
  • Governance approvals
  • Data-linkage project update
  • PROpatient trial IT systems update 
  • New Clinical Working Group
  • Upcoming Meetings 

COVID-19 & PROpatient Update

The PROpatient trial is a registry based trial that has National Mutal Acceptance ethics approval from Monash Health. PROpatient will therefore be following the Monash Health Research Office guidelines (see below).

As per the Monash Heath guidelines PROpatient is categoried under 'other research studies using retrospective chart review, data linkage, remotely completed questionnaires that does not require patients to visit the hospital', and therefore the trial may continue as planned under the original approval conditions. As the trial is currently still in the developmental stages we will provide another COVID-19 update before the trial commences. 

Health professionals involved in the trial: We have momentarily suspended all communication and involvement with health professionals involved in the trial as we know clinical work is the priority at this very difficult time. 

The PROpatient team hopes everyone is staying safe and well! 
Click for Monash Health COVID-19 Clinical Trial Guidelines

What we've been up to... 

Resource Development 

The trial is currently in development stages as we have been progressing with the design of multiple resources that will be used for delivery of the intervention:

-Disease Specific PROM for frequent symptom reporting (intervention arm)
-Symptom self-management resources (intervention arm)
-Escalation Policy
-Site specific support guides 
-Clinician reports 

*Please see protocol (attached to the next section of the newsletter) to find out more detail about each of the resources above

We have also been working on resources developed for the trial: 

-The Personify Care Platform
-REDCap Trial Database and Randomisation Module
-Trial Scripts & Letter Templates
-Statistical Analysis Plan
-Trial Evaluation


Site Visits 

We have been busy over the last 6 months visiting all health service sites that are participating in the trial, and different departments within these health services (i.e. Palliative Care, Chemotherapy, Radiotherapy, Surgery Units and Allied Health Departments).

Many of you would have listened to us present at your health service's multidisciplinary meeting for upper gastrointestinal and/or pancreatic cancer patients.

If you haven't recieved a visit from us and you think it would be important for us to meet your team please email us: and we will organise to meet you!
*All meetings will be held via Zoom currently due to COVID-19. 

The PROpatient team (pictured left to right): Nadia Khan, Tina Griffiths, Carla Edgley, Tennille Lewin, Lisa Brady, Dr Liane Ioannou, Professor John Zalcberg 

Disease-Specific PROM Development Sub-Study

The substudy will use a mixed methods approach including both qualitative and quantitative methods for the development of the PROMs for the second stage of the study.

The sub-study has been approved by the Monash Health HREC and has been designed to form a component of Tennille Lewin's PhD project. Tennille will lead the PROpatient sub-study. 

Qualitative Phase
Three focus groups will be held with patients and caregivers to ascertain their views and perceptions on a long-item tool (developed based on focus groups with health professionals) and a short-item tool (based on the PACADI, a pancreatic cancer-specific 8-item symptom index recommended by the ACQSHC- found here)
To date, two consumer focus groups have been held, with the remaining one to be conducted via video conferencing using the platform Zoom within the next month.

Quantitative Phase
If the results of the consumer focus groups indicate that a short-item tool is preferred, a questionnaire will be distributed to patients with pancreatic and oesophagogastric cancer participating in the Upper Gastrointestinal Cancer Registry. The questionnaire will ask patients to identify ten symptoms that they consider important or have caused them the most concern from the list of 65 symptoms/issues and to then rank these symptoms/issues from 1 to 10 with ‘1’ being the most important and ‘10’ the least. Frequency of responses will be analysed to finalise a short-item tool. 

Acceptability & Feasibility Testing
Acceptability and feasibility testing will be undertaken with consumers required to complete the final PROM on the electronic platform during cognitive ‘think aloud’ interviews. 
The development of the PROM has been overseen by the PROpatient Advisory Working Group, who meet monthly, with oversight from the PROpatient Steering Committee.

Click for Updated Trial Protocol with Sub-Study Included

Governance Approval 

The PROpatient team has been working on obtaining governance approval with your health service's specific research office in order to run the PROpatient Trial at your health service. 

Please see below an update of governance approvals at all PROpatient sites:

Monash Health - Governance approved, ready to commence. 
Jessie McPherson - Governance approved, ready to commence. 
Alfred Health - Governance approved, ready to commence. 
Cabrini Health - Governance approved, ready to commence. 
Eastern Health - Governance approved, ready to commence. 
Peter MacCallum Cancer Centre - Governance approved, ready to commence. 
The Royal Melbourne Hospital - Submitted & currently under review.
St Vincent's HospitalSubmitted & currently under review.
Balllarat HealthSubmitted & currently under review.
Austin Health - Not yet submitted & to be submitted in coming months. 

Many thanks to the site PI's and AI's for assisting with providing documentation, signatures and for responding promptly to emails to facilitate our governance process. 
Click for Recently Updated List of Site PI's & AI's

PROpatient IT System & Data Linkage Project Update

Personify Care

We are pleased to report that we have completed the Monash University procurement process and contract negotiations for Personify Care. Furthermore, a Privacy Impact Assessment (PIA) of the trial has been completed by an external law firm, KPMG. As this is a subscription service, contracts will be signed by Monash University once the trial is ready to commence.

Personify Care will be used to electronically consent patients to the PROpatient trial, enable patients in the control arm of the trial to complete quality of life questionnaires, enable patients in the intervention arm of the trial to complete the PROM intervention tool and request a call from the PROpatient Cancer Nurse Consultants. 

The PROpatient Personify Care system will link with the PROpatient database and allow seamless transition of trial data for patients enrolled in the trial. 


Data Linkage Project 

The Upper Gastrointestinal Cancer Data Linkage Project aims to map the patterns of supportive care utilisation, pain management and adjuvant therapy utilisation in pancreatic and oesophagogastric cancers across Victoria.

A range of administrative and registry-based data sets will be linked by the Centre for Victorian Data Linkage.

Ethics approval has been obtained and phase 1 of the linked data is anticipated to be available for analysis in mid-2020. This work will be supplemented with patient/caregiver interviews (currently ongoing) and clinician surveys to understand the barriers and enablers associated with supportive care utilisation. 

RECRUITING: New Clinical Working Party 

We are currently looking for clinicians to join our new PROpatient Clinical Working Party. 

A clinical working party will be formed by physicians, nurses and relevant allied health staff. T
he clinical working party will assis the PROpatient research team in developing the clinical care pathways/algorithms, including the escalation policy and the overarching decision support guide, for each of the symptoms/clinicla issues self-reported by participants in real-time in the intervention arm of the trial.  
We anticipate that this process will take approximately 4-6 months.
Once the overarching decision support guide is finalised the PROpatient research team will meet with site representatives to modify the guide to ensure it is specific and acceptable at a site-level. 

We understand that due to time constraints and clinical commitments that participation in this group may be difficult and therefore we have two different options for participating.
These are: 

1.  Operations Member (attend one meeting monthly in person and/or via video conference) 
2. Clinical Working Party (email updates only and opportunity to give input via email)
3. Clinical Champion (responsible for review of a symptom guideline for the trial e.g. for all patients who report pain) 

We would like to have as many clinicians from each health service site possible participating in the PROpatient Clinical Working Party. If you have not received an invitation and wish to participate or you have someone you would like to nominate please email PROpatient@monash.eduThis would be a great opportunity to get involved in research that could help to support patients at your health service, and also  for clinicians looking to get involved in research. 

*Please note Clinical Working Party meetings have been put on hold due to COVID-19. We will update those who are participating when they will begin as soon as we are aware. 

Upcoming Meetings...

Please pass it on.... 

We would love to share the PROpatient Trial with anyone who is interested so if you think there is someone important missing out on our newsletter, please forward it on or share this in a tweet (click on the relevant button below)! 
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You can find previous PROpatient newsletters here (scroll to bottom of webpage). 
You can find previous Upper GI Cancer Registry newsletters here (scroll to bottom of webpage). 

Project Details

Project Team:  
Coordinating PI- Prof John Zalcberg 
Co-Coordinating PI - Dr Liane Ioannou
Nurse Consultant- Lisa Brady
Nurse Consultant- Tina Griffiths
Research Assistant- Carla Edgley 
PhD Candidate- Tennille Lewin
PhD Candidate- Nadia Khan
Contact Us:  
P: 1800 975 255

PROpatient Research Output
Click for PROpatient Steering Committee
Click for PROpatient Advisory Working Party
The PROpatient Trial would like to thank the Victorian Cancer Agency, the Upper Gastrointestinal Cancer Registry, the School of Public Health and Preventive Medicine units including the Registry Sciences Unit, the Victorian Cancer Registry and participating health services, who have provided support to the trial.
Copyright © 2019 PROpatient - a registry based randomised control trial associated with the Upper Gastrointestinal Cancer Registry, All rights reserved.
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Our mailing address is:
PROpatient Trial - Upper Gastrointestinal Cancer Registry 
School of Public Health and Preventive Medicine 
Monash University
Level 2, 553 St Kilda Road
Melbourne, Victoria 3004

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