Virtual Multimodal Hub for Patients Undergoing Major Gastrointestinal Cancer Surgery - PRIORITY-CONNECT 2 Pilot Randomised Type I Hybrid Effectiveness-Implementation Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates
研究概览
简要总结
The provision of preoperative interventions (prehabilitation: including exercise, nutrition, and psychological treatment) have been reported to reduce postoperative complications by as much as 50% and reduce hospital stay by up to 4 days compared to standard of care. Postoperative multimodal interventions are likely to further benefit patients facing new challenges (e.g. stoma care), and reduce post discharge complications.
Therefore the Virtual Multimodal hub of PRIORITY-CONNECT 2 Pilot Trial aims to primarily; determine the feasibility of incorporating a virtual multimodal program into the preoperative and postoperative period for patients undergoing gastrointestinal cancer surgery, the acceptability to patients, clinicians and carers of the virtual multimodal program and the acceptability to patients of being randomised to the virtual multimodal program or usual care.
The secondary aim is to obtain pilot data on the likely difference in key outcomes (30 days postoperative complications, quality of life, days at home and alive at 30 days - DAH30, implementation outcomes and cost outcomes) to inform the development of a substantive randomised clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Consenting participants will undergo baseline assessment immediately prior to randomisation to intervention (virtual multimodal hub and usual care) or control group (usual care alone). The randomisation sequence will be prepared a priori using a central secure randomisation service (1:1 allocation ratio in random permuted blocks of sizes 4 or 2 stratified by hospital, to ensure balance intreatment assignment within hospital) to ensure concealment of treatment allocation and blinding of surgeon, all trial personnel and statistician. Due to the nature of the intervention, it is not possible to blind the clinicians delivering the intervention (virtual multimodal hub); however, the investigators will ensure that all patients' interactions are standardised.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years undergoing major gastrointestinal elective surgery, including liver, pancreas, oesophagus, gastric and colorectal cancer resections with curative intent
- •Consulting with a gastrointestinal cancer surgeon at least 1 week prior to scheduled surgery
排除标准
- •Cognitive impairment such that they are unable to provide informed consent
- •No access to a smart device (including mobile phone, tablet, laptop or desk computer with camera) or no internet connection
结局指标
主要结局
Feasibility of the virtual multimodal hub determined by number of eligible participants, retention rate and adherence rates
时间窗: through study completion, an average of 1 year
Feasibility will be determined by the following outcomes: (i) Number of eligible participants recruited to the pilot trial; (ii) Retention rate: defined as the percentage of participants who completed the trial; (iii) Adherence rates: defined as the percentage of planned sessions attended by those who were randomised to the intervention group.
Acceptability of the virtual multimodal hub.
时间窗: 3 months, through study completion, an average of 1 year
Patients, clinicians and carers acceptability to the virtual multimodal hub (Intervention) will be assessed with a semi-structured questionnaire administered at 3-months (last survey). The semi- structured questionnaire contains 11 questions and participants (Patients, clinicians and carers) will be instructed to use a 5-point Likert Scale to express how much they agree or disagree with each statement. In addition, patients will be asked how satisfied they were with the virtual multimodal program and if the program negatively affected them. The investigators have also taken the opportunity to seek further feedback about the virtual multimodal hub (open ended question). The questionnaire has been used on previous pilot trials.
次要结局
- Quality of life outcome EORTC QLQ-OG25(Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.)
- Implementation Outcome: Reach(through study completion, an average of 1 year)
- Implementation Outcome: Adoption(through study completion, an average of 1 year)
- Postoperative complications within 30 days after surgery(30 days after surgery)
- Quality of life outcome EORTC QLQ-C30(Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.)
- Implementation Outcome: Effectiveness(through study completion, an average of 1 year)
- Implementation Outcome: Implementation(through study completion, an average of 1 year)
- Quality of life outcome EORTC QLQ-CR29(Measured at baseline, 1-2 day(s) before surgery, day of hospital discharge, 1- and 3-months post index surgery.)
- Number of days at home within 30 and 90 days of surgery(days at home within 30 and 90 days of surgery)
- Resource use(1-6 weeks prior to surgery to 3 months post index surgery.)
- Implementation Outcome: Maintenance(through study completion, an average of 1 year)