None listed
Conditions
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.
Interventions
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 COM-B framework has been used as a theoretical basis for the intervention development (Michie et al, 2011). The intervention includes a variety of evidence-based behaviour change strategies and has been based on Behaviour Change Techniques Taxonomy (Michie et al, 2013). 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 checklists 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 checklist; 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.
Sponsors
Study design
Eligibility
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.
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.