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Trial registered on ANZCTR


Registration number
ACTRN12624000417583
Ethics application status
Approved
Date submitted
17/08/2023
Date registered
5/04/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
5/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial assessing feasibility, acceptability, preliminary efficacy and cost-effectiveness of RecoverEsupport Breast: A Digital health intervention to support breast cancer patients in their preparation for and recovery from surgery.
Scientific title
A pilot randomised controlled trial assessing feasibility, acceptability, preliminary efficacy and cost-effectiveness of RecoverEsupport Breast: A Digital health intervention to support breast cancer patients in their preparation for and recovery from surgery.
Secondary ID [1] 310349 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 331081 0
Condition category
Condition code
Cancer 327871 327871 0 0
Breast

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 breast cancer surgery. The RecoverEsupport intervention is a multicomponent intervention based around a purpose-built online program. 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 physio exercises.

What: In addition to the online program, the RecoverEsupport intervention also includes provision of patient prompts (to access the online program and to remind them of, and to monitor and record their behaviours), and clinician prompts (alerting nursing staff when patients are not adhering to the ERAS recommendations).

Procedures: The intervention includes a variety of evidence-based behaviour change strategies as described in the framework by Wang et al for classifying digital health interventions for behaviour change (2019 JMIR). These strategies include: Self-monitoring and feedback; 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.
Strategies are operationalised through: daily diaries with feedback (provided to the patients and clinical team) and automatic non-compliance alerts provided to the clinical team; prompts and reminders to access the online program and complete the daily diaries; and provision of information via the online program in the form of text, videos, diagrams and quiz questions.

How: (Delivery Mode) Intervention content will be provided via an online program, SMS and email. The device the intervention is accessed on is at the discretion of the participant (computer, tablet, or smartphone). To increase patient 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 online program are a series of informational videos which are delivered by clinicians (the Surgeon, Anaesthetist, Breast Care Nurses, Exercise Physiologist). 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 online program 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 designed to be accessed in the hospital post-surgery.


When and how much: The online program will be accessible on-demand for the patient throughout the trial. It is suggested that participants log on to the online program 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 online program and monitor and record their behaviour. 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.

The duration of engagement will be at the discretion of the participant; however, it is envisaged that participants will spend approximately 1-2 hours using the online program before their surgery, and then approximately 5-10 minutes each day in hospital following their surgery, and then approximately 10 minutes per day for the following 4 weeks.

Tailoring: Patients will receive tailored feedback from within the online program and (if applicable) from the nurse as a result of the monitoring of their daily behaviours.

How well: Use and access to the online program 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] 326747 0
Treatment: Other
Intervention code [2] 326748 0
Rehabilitation
Intervention code [3] 326749 0
Behaviour
Comparator / control treatment
Usual Care: All patients will receive usual care regarding preparation for and recovery from surgery.
Control group
Active

Outcomes
Primary outcome [1] 335717 0
Feasibility of the RecoverEsupport intervention will be assessed based on the following pre-specified targets:

(1) Participant recruitment (Target: N=70 participants consent to the study)
(2) Retention rate (Target: >85% remain in the study at 1 month follow-up (i.e. have not withdrawn)
(3) Data collection (Target: >85% of participants from the study have Length of Stay data collected)
(4) Adverse events (Target – no adverse events classified as Grade 3 or above, based on items that have been adapted from the Common Terminology Criteria for Adverse Events including falls, muscle pain/discomfort, and anxiety)


Acceptability of the RecoverEsupport intervention will assessed among intervention participants (only), and will be based on the following:
(1) Intervention usability (Target: Average score on the System Usability Scale >68 i.e. Okay” or higher), measured at 1-month post-surgery.
(2) Intervention engagement: Use of ‘RecoverEsupport’, measured at 1-month and 3-months post-surgery. Use of the online program will be monitored through analytics automatically recorded by REDcap.
(3) Intervention component acceptability: A series of questions using Likert scale response options will assess the acceptability of characteristics of the intervention components, measured at 1-month post-surgery.
Timepoint [1] 335717 0
1 and 3-month post surgery
Primary outcome [2] 337623 0
Preliminary efficacy:
Length of Stay: Reported in Days and hours, as recorded by Local Health District Medical Records (MR) data.
Timepoint [2] 337623 0
At hospital discharge
Secondary outcome [1] 432567 0
Quality of life (QoL) assessed via the EORTC QLQ-C30
Timepoint [1] 432567 0
Measured at Baseline, 1- & 3-months post-surgery
Secondary outcome [2] 432568 0
Quality of Recovery (QoR) assessed via the QOR-15
Timepoint [2] 432568 0
Measured post-operatively (in hospital), and at 1- & 3-months post-surgery.
Secondary outcome [3] 432569 0
Anxiety assessed via The Hospital Anxiety and Depression Scale (HADS)
Timepoint [3] 432569 0
Assessed at baseline, 1-month and 3-months post-surgery.
Secondary outcome [4] 432570 0
Patient behaviours related to patient-managed ERAS recommendations (pre-admission behaviours and mobilisation, oral diet, fluid intake, opioid minimisation, and physio exercises), assessed via questions developed specifically for the study,
Timepoint [4] 432570 0
Measured post-operatively (in hospital).
Secondary outcome [5] 432571 0
Hospital re-admissions and Emergency Department visits assessed via Local Health District Medical Records data and an adapted version of the Client Service Receipt Inventory (CSRI). (A clinician will review the re-admissions/visits to identify those that are related to breast surgery).
Timepoint [5] 432571 0
Measured at 3-months post-surgery.
Secondary outcome [6] 432572 0
Health Service utilisation post-discharge: assessed via an adapted version of the Client Service Receipt Inventory (CSRI),
Timepoint [6] 432572 0
Measured at 3-months post-surgery.
Secondary outcome [7] 432573 0
The intervention cost, cost consequence and cost-effectiveness.
Timepoint [7] 432573 0
Cost data will be collected throughout the duration of the intervention based on detailed project management records, assessed at the conclusion of the study at 3 months post-surgery.

Eligibility
Key inclusion criteria
Patients aged 18+ years with a planned mastectomy with or without a breast reconstruction for breast cancer; or a reconstruction following a mastectomy; English speaking; cognitively and emotionally able to participate; have internet access and who have access to an email address or phone that can receive SMS messages.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are unable to provide independent informed consent; those under 18 years of age; patients having 'autologus' reconstructions (DIEP/TRAM/LDs), those who have previously participated in this study, and those who require emergency surgery.

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 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
Blinding of participants to group allocation will not be possible for this trial, as both the participant and nursing staff will be aware of whether the person is receiving the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Length of stay, hospital admissions and ED visits, will be modelled using general linear models. Fixed effects will be included for treatment group and baseline QoL.
QoL, QoR, and anxiety will be modelled using generalised linear mixed models. Fixed effects will be included for treatment group, time point, the interaction between treatment group and time, and baseline QoL / QoR, and a random effect for participant ID will be included to account for the repeated measures on individuals.

All analyses will be conducted with the Bayesian Framework using non-informative priors. Effect measures will be reported as the mean difference between the treatment groups (and 95% Credible Intervals), or Incident Rate Ratios (IRR) and 95% Credible Intervals, alongside the posterior probability of a treatment effect, and Bayes Factors will be calculated a measure of evidence against the null.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
70
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25354 0
Calvary Mater Newcastle - Waratah
Recruitment postcode(s) [1] 41083 0
2298 - Waratah

Funding & Sponsors
Funding source category [1] 314555 0
Other
Name [1] 314555 0
Cancer Council NSW: Early Career Development Fellowship (2021/ECF1355)
Country [1] 314555 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive, Callaghan NSW 2308, Australia
Country
Australia
Secondary sponsor category [1] 316513 0
None
Name [1] 316513 0
Address [1] 316513 0
Country [1] 316513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313592 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 313592 0
HNE Research Office, Locked Bag 1, New Lambton NSW 2305
Ethics committee country [1] 313592 0
Australia
Date submitted for ethics approval [1] 313592 0
31/10/2022
Approval date [1] 313592 0
15/12/2022
Ethics approval number [1] 313592 0
2022/ETH02010

Summary
Brief summary
This randomised controlled pilot trial will test the feasibility, acceptability, preliminary efficacy and cost-effectiveness of a digital health intervention (RecoverEsupport) among breast cancer patients undergoing surgery.

Who is it for?
You may be eligible for this trial if you are aged between 18 years or older, have been diagnosed with breast cancer, and are planning to undergo mastectomy with or without a breast reconstruction, or a breast reconstruction (following a previous mastectomy)

Study details
Eligible patients will be recruited at the pre-surgical consultation or the peri-operative clinic. Consenting patients will be asked to complete surveys at: baseline, post-surgery during the hospital admission, and post-discharge (1- and 3-months post-surgery).

Following completion of the baseline survey, patients will be randomly allocated to the control group (receiving standard care), or the intervention group (receiving the RecoverEsupport program):
RecoverEsupport is a digital health intervention aimed at improving adherence to patient-led ERAS recommendations. The intervention includes an online program (accessible to patients) and a series of prompts for patients and clinicians to encourage continued self-management.

It is hoped this intervention will assist in overcoming some of the barriers to implementation of the ERAS pathway. If effective, the intervention could be rapidly rolled-out at scale and adapted for other surgical patient groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128674 0
A/Prof Rebecca Wyse
Address 128674 0
University of Newcastle Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country 128674 0
Australia
Phone 128674 0
+61 2 4042 0272
Fax 128674 0
Email 128674 0
[email protected]
Contact person for public queries
Name 128675 0
Emma Sansalone
Address 128675 0
University of Newcastle Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country 128675 0
Australia
Phone 128675 0
+61 2 4042 0964
Fax 128675 0
Email 128675 0
[email protected]
Contact person for scientific queries
Name 128676 0
Emma Sansalone
Address 128676 0
University of Newcastle Lot 1 Kookaburra Cct, New Lambton Heights NSW 2305
Country 128676 0
Australia
Phone 128676 0
+61 2 4042 0964
Fax 128676 0
Email 128676 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 ethical permission to share data at this level.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19966Study protocol  [email protected] Available through contacting the contact person fo... [More Details]
19967Ethical approval  [email protected] Available through contacting the contact person fo... [More Details]



Results publications and other study-related documents

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No additional documents have been identified.