Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001533886
Ethics application status
Approved
Date submitted
9/09/2021
Date registered
10/11/2021
Date last updated
20/02/2024
Date data sharing statement initially provided
10/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness and cost-effectiveness of a web-based intervention to support colorectal cancer patients prepare for and recover from surgery: A randomised controlled trial of the RecoverEsupport intervention.
Scientific title
A randomised controlled trial of the effectiveness and cost-effectiveness of RecoverEsupport, a web-based intervention to support colorectal cancer patients' preparation for and recovery from surgery.
Secondary ID [1] 305269 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 323562 0
Condition category
Condition code
Cancer 321112 321112 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Public Health 321354 321354 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The RecoverEsupport digital health intervention: OVERVIEW: RecoverEsupport is a digital health intervention to support patients to prepare for and recover from bowel cancer surgery. The RecoverEsupport intervention is a multicomponent intervention based around a purpose-built website. It is designed to be used pre-surgery, post-surgery and post-discharge, and focuses primarily on patient-managed behaviours to enhance their preparation for and recovery from surgery. Specifically, it supports patients to adhere to the evidence-based patient-led ERAS (Enhanced Recovery After Surgery) recommendations to optimise their recovery. Recommended behaviours include early mobilisation, early oral diet, early fluids, minimisation of opioids and breathing exercises. The intervention is also designed to be accessed by a patient's support person, so that they can support the patient at each stage of the patient journey.

What: In addition to the website, the RecoverEsupport intervention also includes provision of patient prompts (to access the website and to monitor and record their behaviours), clinician prompts (alerting nursing staff when patients are not adhering to the ERAS recommendations) and GP prompts (a list of side effects to ask the patients about post-discharge and management strategies for each side effect - provided once following discharge). Prompts can take the form of SMS, email or fax (GPs only).
Procedures: The intervention includes a variety of behaviour change strategies including: Self-monitoring and feedback; Provision of Social support; Instruction on how to perform the target behaviours; Provision of information about health consequences; Provision of information from a credible source; Demonstration of behaviour; Provision of Prompts/cues, as described in the framework by Wang et al for classifying digital health interventions for behaviour change (2019 JMIR). Strategies are operationalised through the use of daily diaries with feedback provided and automatic non-compliance alerts sent to the clinical team; prompts and reminders to access the website, complete the daily diaries; access for a nominated support person; and provision of information via text, videos, diagrams and via quiz questions.
How: (Delivery Mode) Intervention content will be provided via website, SMS, email, and fax (GP only). The device the intervention is accessed on is at the discretion of the participant (computer, tablet, or smartphone). To increase the intervention groups’ participation during their hospital stay, they will be encouraged to bring their tablet or laptop with them. Patients without access to a tablet or laptop will have one provided during their hospital stay.
Who: Embedded in the website are a series of informational videos which are delivered by members of the clinical team (Surgeon, Anaesthetist, Stoma Nurse). The intervention prompts are ostensibly from members of the clinical team. The nurse receives a prompt when patients are not adhering to the targeted patient-led ERAS recommendations.
Where: The intervention has been designed to be accessed in the home (or wherever most convenient for the participants) during the pre-surgical and post-discharge phases, and then designed to be used in the hospital post-surgery.
When and how much: The website will be accessible on-demand for both the patient and their support person throughout the trial. It is suggested that participants log on to the website as many times as they need in the pre-surgical phase. Post-surgery, during their hospital stay, they will be prompted daily to access the website and monitor and record their behaviour. This is anticipated to take approximately 5-10 minutes each day. The intervention group will have access to the RecoverEsupport program from the time they complete the baseline surveys (approx 2 weeks pre-surgery) until 3 months post-surgery. It is anticipated that to complete all the content on the website, it would take participants approximately 2-3 hours.
Tailoring: Patients will receive tailored feedback from within the website and (if applicable) from the nurse as a result of the monitoring of their daily behaviours.
How well: Use and access to the website will be tracked through analytics to allow assessment of intervention fidelity.

As yet, there have been no modifications to the registered protocol.
Intervention code [1] 321669 0
Treatment: Other
Intervention code [2] 321670 0
Behaviour
Comparator / control treatment
Usual Care: All patients will attend the pre-surgical consultation and perioperative clinic. Other aspects of care will be consistent with usual care i.e. an inpatient stay of approximately 3-7 days, with daily check-ups by the nursing staff.
Control group
Active

Outcomes
Primary outcome [1] 328889 0
Length of Stay: The time elapsed between surgery and discharge, as recorded by Local Health District Medical Records (MR) data
Timepoint [1] 328889 0
At discharge
Secondary outcome [1] 400795 0
Days Alive and Out of Hospital (DAOH90). Admitted bed days includes those immediately following the index surgery and during readmissions, and will be captured by searching the Local Health District Medical Records (MR) data and confirmed through patient-self report.
Timepoint [1] 400795 0
1- and 3-months post-surgery.
Secondary outcome [2] 400796 0
The number of Emergency Department presentations, captured via Medical Records data. A colorectal cancer nurse will review the presentations to identify those that are related to their colorectal surgery.
Timepoint [2] 400796 0
1- and 3-months post-surgery
Secondary outcome [3] 400797 0
Quality of life (QoL) assessed via the QLQ-C30
Timepoint [3] 400797 0
Baseline, 1- & 3-months post-surgery
Secondary outcome [4] 400798 0
Patient behaviours related to patient-managed ERAS recommendations (e.g. mobilisation, oral diet, fluid intake, opioid minimisation, deep breathing and coughing exercises) via patient self-report through an online survey designed specifically for this study
Timepoint [4] 400798 0
Assessed at a single time point post-surgery during the hospital admission (e.g. day 2 post-surgery), and at a single time point 1-month post-surgery.
Secondary outcome [5] 400799 0
Health care costs measured via Medical Records and a modified version of the Client Services Receipt Inventory
Timepoint [5] 400799 0
1- and 3-months post-surgery
Secondary outcome [6] 400800 0
Use of ‘RecoverEsupport’. Use of the website will be monitored through analytics.
Timepoint [6] 400800 0
1-month post-surgery
Secondary outcome [7] 401569 0
Quality of life (QoL) assessed via the QLQCR29
Timepoint [7] 401569 0
Baseline, 1- & 3-months post-surgery
Secondary outcome [8] 401570 0
Patient knowledge related to patient-managed ERAS recommendations (e.g. mobilisation, oral diet, fluid intake, opioid minimisation, deep breathing and coughing exercises) via patient self-report through an online survey designed specifically for this study
Timepoint [8] 401570 0
Assessed at a single time point post-surgery during the hospital admission (e.g. day 2 post-surgery), and at a single time point 1-month post-surgery.
Secondary outcome [9] 401571 0
Acceptability of ‘RecoverEsupport’ will be assessed among intervention participants and their support person(s), as part of the 1-month follow-up survey, and will examine ease of use, relevance and quality of the support and information accessed, via patient self-report through an online survey using items specifically developed for this study (not validated)
Timepoint [9] 401571 0
1-month post-surgery
Secondary outcome [10] 431894 0
Quality of Recovery accessed by The Quality of Recovery Scale-15.
Timepoint [10] 431894 0
baseline, in-hospital, 1-month and 3-months

Eligibility
Key inclusion criteria
Patients aged 18+ years with a planned bowel resection for colorectal cancer (up to 3 days to surgery); have an expected inpatient stay of at least three days; have internet access; are free from cognitive impairment, physically and emotionally capable, and are literate in English. (Nb. Support persons, if present, are also eligible to participate).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to provide independent informed consent; those who are physically and/or psychologically not capable, those with advanced disease who have taken daily opiate analgesia for more than 1 month of the prior 12 months; and those who require emergency surgery or insertion of a stent.

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 was concealed through use of central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation will be programmed by an independent statistician using REDcap software with block sizes varying randomly from 4 to 6
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
Between-group differences in Length of Stay will be compared using regression adjusted for baseline QoL. The incremental cost-effectiveness ratio (ICER) will be calculated as the difference in mean total cost divided by the observed difference in the primary outcome. Sensitivity and scenario analysis will be undertaken to test the impact of changing key design features of the intervention.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/06/2022
Actual
6/07/2022
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
334
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20497 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 26188 0
Newcastle Private Hospital - New Lambton Heights
Recruitment postcode(s) [1] 35274 0
2305 - New Lambton
Recruitment postcode(s) [2] 42064 0
2305 - New Lambton Heights

Funding & Sponsors
Funding source category [1] 309638 0
Government body
Name [1] 309638 0
NHMRC
Country [1] 309638 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Drive, Callaghan NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 310657 0
None
Name [1] 310657 0
Address [1] 310657 0
Country [1] 310657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309410 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 309410 0
Ethics committee country [1] 309410 0
Australia
Date submitted for ethics approval [1] 309410 0
31/07/2015
Approval date [1] 309410 0
09/09/2015
Ethics approval number [1] 309410 0
2019/ETH00869

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

Contacts
Principal investigator
Name 114062 0
A/Prof Stephen Smith
Address 114062 0
HMRI
Locked Bag 1000
New Lambton, NSW, 2305
Country 114062 0
Australia
Phone 114062 0
+61 2 4042 0000
Fax 114062 0
Email 114062 0
[email protected]
Contact person for public queries
Name 114063 0
Rebecca Wyse
Address 114063 0
Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2287
AUSTRALIA
Country 114063 0
Australia
Phone 114063 0
+61 2 404 20272
Fax 114063 0
Email 114063 0
[email protected]
Contact person for scientific queries
Name 114064 0
Rebecca Wyse
Address 114064 0
Hunter New England Population Health
Locked Bag 10
WALLSEND NSW 2287
AUSTRALIA
Country 114064 0
Australia
Phone 114064 0
+61 2 404 20272
Fax 114064 0
Email 114064 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
IPD will not be available as we do not have ethics approval to share data at this level.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13139Study protocolProtocol for publications is in preparation - contact researchers for access [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness and cost-effectiveness of a digital health intervention to support patients with colorectal cancer prepare for and recover from surgery: study protocol of the RecoverEsupport randomised controlled trial.2023https://dx.doi.org/10.1136/bmjopen-2022-067150
N.B. These documents automatically identified may not have been verified by the study sponsor.