None listed
Conditions
Brief summary
This study is aimed at testing the effectiveness and cost-effectiveness of the RecoverEsupport digital health program in supporting colorectal cancer patients undergoing surgery. Who is it for? You may be eligible for this trial if you are aged 18 years or older, have been diagnosed with colorectal cancer, and are planning to undergo bowel resection with an expected inpatient stay of at least 3 days. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either the intervention or a usual care group. Participants allocated to the intervention will be asked to access the RecoverEsupport website to complete online activities, learn about pre- and post-surgery behaviours, and access behaviour change strategies to enhance their recovery. Participants and clinicians will also receive prompts (e.g. SMS or email) to support adherence to Enhanced Recovery After Surgery (ERAS) recommendations. This intervention will occur from 2 weeks before surgery, to 3 months after surgery. Those participants who are randomised into the control group will receive usual care. Questionnaires will be collected at baseline, post-surgery, 1 months and 3 months after surgery. It is hoped this intervention will facilitate improved implementation of ERAS, and improve patients' recovery from surgery.
Interventions
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.
Sponsors
Study design
Eligibility
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).
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.