Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000096954
Ethics application status
Approved
Date submitted
13/11/2019
Date registered
4/02/2020
Date last updated
4/02/2020
Date data sharing statement initially provided
4/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Is it possible to deliver targetted cancer surgery educational material using an internet-based webinar platform and improve outcomes after surgery: The Virtual PRIME initiative.
Scientific title
Virtual PRIME initiative: feasibility and impact of a preoperative telehealth educational intervention on postoperative. outcomes in patients awaiting major abdominal cancer surgery
Secondary ID [1] 299528 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major abdominal cancer surgery 314799 0
Condition category
Condition code
Cancer 313139 313139 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 313140 313140 0 0
Stomach
Cancer 313141 313141 0 0
Sarcoma (also see 'Bone') - soft tissue
Oral and Gastrointestinal 314167 314167 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative education pack entitled ' Surgery School' includes six informational modules based on current evidence. Information is delivered in one session anytime from 2 weeks and up to 6 weeks prior to anticipated surgery date via either in-person presentations at the hospital (3 hour session, approximately 20mins per module) or via a web-based webinar platform (1.5 hour session, approximately 10mins per session) which patients can access anywhere they have an internet connection e.g. home/friend's house/community centre.
Surgery School includes:
- Introduction to Surgery School
- aCOUGH: targeted pulmonary optimisation package using active cycle of breathing technique, oral care, early mobilisation and bed head elevation
- Pain management: discussion of expectation of pain after surgery, multimodal analgesia and analgesic delivery options
- Nutrition: discussion of nutritional optimisation before and after surgery
- Psychology: discussion of psychological preparedness for surgery
- Exercise: discussion of exercise optimisation before and after surgery
- ERAS: evidence-based multimodal perioperative care pathway designed to achieve early recovery after major surgery that has been proven to lower postoperative complication rates.

The intervention will be delivered by presenters from our multidisciplinary team (Physiotherapist, Anaesthetist, Pain Nurse, Psychologist and Dietitian).
Intervention code [1] 315795 0
Prevention
Intervention code [2] 316448 0
Treatment: Other
Intervention code [3] 316449 0
Rehabilitation
Comparator / control treatment
Standard care is defined as any preoperative consultation, evaluation and associated education provided at the pre-anaesthetic clinic as part of routine clinical care pathways. Patients that decline participation in either of the surgery school formats will form the comparator/control group.
Control group
Active

Outcomes
Primary outcome [1] 321667 0
The number (%) of participants who 'attend' (watch/listen) to at least 1 module (at least 10mins) of the webinar-based pre-operative education platform and assessed by time attended on attendee report built into webinar software.
Timepoint [1] 321667 0
Prior to surgery
Secondary outcome [1] 375818 0
Satisfaction of Surgery School content as assessed by Likert scales on a questionnaire developed for this study.
Timepoint [1] 375818 0
Immediately post attendance at Surgery School
Secondary outcome [2] 375819 0
The number (%) of participants who reported acting on Surgery School recommendations when asked by interviewer as part of a structured phone interview two weeks after attendance at Surgery School.
Timepoint [2] 375819 0
Structured phone interview two weeks after attending Surgery School.
Secondary outcome [3] 375820 0
The number (%) of participants who reported elements of Surgery School remembered when asked as part of a structured phone interview two weeks after attending Surgery School.
Timepoint [3] 375820 0
Structured phone interview two weeks after attending Surgery School.
Secondary outcome [4] 375821 0
Self-reported preparedness for surgery as assessed by Likert scale in a questionnaire specifically developed for this study immediately after attendance at Surgery School.
Timepoint [4] 375821 0
Immediately after completion of Surgery School.
Secondary outcome [5] 375822 0
Postoperative pulmonary complications as defined by the Standardized Endpoints for Perioperative Medicine (StEP) Collaborative definitions of post-operative pulmonary complications
Timepoint [5] 375822 0
Thirty days post-operatively.
Secondary outcome [6] 378384 0
Time to mobilisation as defined as the number of days post-operatively until documentation of patient mobilising out of the bed via review of the medical records
Timepoint [6] 378384 0
Once 30days post-operatively
Secondary outcome [7] 378385 0
Length of hospital stay assessed at discharge (via hospital medical record)
Timepoint [7] 378385 0
once upon discharge from hospital
Secondary outcome [8] 378386 0
Compliance with aCOUGH pathway postoperatively as assessed by components completed on aCOUGH prescription chart in medical records in first five days post-operatively.
Timepoint [8] 378386 0
once at day 5 post-operatively.
Secondary outcome [9] 378387 0
Days alive and out of hospital at 30 days as assessed by number of inpatient days in first 30days post-operatively in hospital medical record and clarification by patient of any readmission to other hospitals within 30 days post-operatively.
Timepoint [9] 378387 0
once at 30 days post-operatively.

Eligibility
Key inclusion criteria
- Greater than 18 years of age
- Upper gastrointestinal surgeries including oesophagectomy, lower gastrointestinal operative including pelvic exenteration and major sarcoma procedures
- Anticipated to have >1 day length of stay
- Anticipated surgery of greater or equal to 120 minutes.
- Sufficient English language skills to understand and follow the aCOUGH pathway.
There is no time period restriction prior to surgery in place for this study as it gives the research team an indication of feasibility if there is not enough time to provide the intervention.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Insufficient English to understand study requirement
- Documented history of cognitive impairment

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14950 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28236 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304019 0
Charities/Societies/Foundations
Name [1] 304019 0
Peter MacCallum Cancer Foundation
Country [1] 304019 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan St
Parkville, VIC, 3000
Country
Australia
Secondary sponsor category [1] 304217 0
None
Name [1] 304217 0
Address [1] 304217 0
Country [1] 304217 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304511 0
Peter MacCallum Cancer Centre Low and Negligible Risk Ethics Committee
Ethics committee address [1] 304511 0
Ethics committee country [1] 304511 0
Australia
Date submitted for ethics approval [1] 304511 0
06/09/2019
Approval date [1] 304511 0
31/10/2019
Ethics approval number [1] 304511 0
19/164L

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

Contacts
Principal investigator
Name 97206 0
Dr Rani Chahal
Address 97206 0
Peter MacCallum Cancer Centre
305 Grattan St,
Parkville, VIC 3000
Country 97206 0
Australia
Phone 97206 0
+61 3 8559 7675
Fax 97206 0
Email 97206 0
[email protected]
Contact person for public queries
Name 97207 0
Jamie Waterland
Address 97207 0
Peter MacCallum Cancer Centre
305 Grattan St
Parkville, VIC. 3000
Country 97207 0
Australia
Phone 97207 0
+61 3 8559 8223
Fax 97207 0
Email 97207 0
[email protected]
Contact person for scientific queries
Name 97208 0
Rani Chahal
Address 97208 0
Peter MacCallum Cancer Centre
305 Grattan St,
Parkville, VIC 3000
Country 97208 0
Australia
Phone 97208 0
+61 3 8559 7675
Fax 97208 0
Email 97208 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


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.