WhatsApp-assisted Prehabilitation Programme for Adult Patient Undergoing Elective Colorectal Cancer Surgery - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative complications
研究概览
简要总结
The goals of this study is to evaluate the feasibility and the effects of a WhatsApp-assisted prehabilitation for colorectal cancer patients undergoing elective surgery. The main questions are: If the digital prehabilitation is feasible and acceptable by the colorectal cancer patient prior to elective surgery? If this prehabilitation helps to improve the postoperative complications, length of stay, physical activity and psychological well-being for colorectal cancer patients receiving surgery.
Researcher will compare the prehabilitation plus standard care to standard care only to see if the prehabiliation helps the colorectal cancer patients.
Participants will: 1) enrolled in a approximate 4 weeks (3 episodes/ week) prehabilitation program containing educational information of colorectal cancer, dietary advice, exercises training and psychological podcasting. 2) will answer the survey weekly and after surgery. 3) keep the standard care as per department guidelines
详细描述
Colorectal cancer ranks the second most prevalent forms of cancer in Hong Kong and surgery is still the primary curative option. Although compromising result of shorten general length of stay (LOS) in enhanced recovery after surgery (ERAS) protocol is illustrated, surgical complications such as postoperative ileus (POI) remain unresolved and significant burden associated leads to suboptimal patients' outcomes of prolonged LOS and physical deconditioning with extended rehabilitation. Prehabilitation refers to optimization in a single or multi-disciplinary approach of exercises training, nutritional therapy and psychological counselling, improves physical fitness, strengthens cardiopulmonary function and reduce mental distress through lifestyle modification and better physiological reserve. However, the concept of educations in form of preoperative exercises and nutritional counselling outweighs the purposes of actual prehabilitation and short-handed allied health professionals limited accessibility of regular out-patient counselling in the current clinical practices. Consequently, poor adherence to these preoperative trainings may result in to poor surgical outcomes.
A single with assessor-blinded, double-armed randomised controlled trial study with a prior pilot will be employed to examine the feasibility and effects of a technology-assisted prehabilitation for patients with colorectal cancer surgery. Outcomes of postoperative complications, LOS, physical activity, nutritional status, gastrointestinal recovery and psychological well-being will be evaluated. Elective colorectal cancer surgery patient will be invited to participated in this study.
The result will provide insights of the use of digital approach. To our knowledge, this is the very first trial of digital prehabilitation for CRC patients in Hong Kong public hospitals. Therefore, it provides positive contribution and acts as an important quality benchmark for patients' outcomes. The findings will also generate knowledge on the optimalization of care provided to CRC patients prior to surgery and assist to develop a structured and effective health system in our community. This innovation may have implications to other research studies and extends the potential clinical practices to related subspecialities such as gastric cancer.
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
- Single (Outcomes Assessor)
盲法说明
A computer-based randomization will be utilized to allocate patients into either one group. Eligible participants will be randomly assigned in a 1:1 ratio to either control group or intervention group. Block randomization was performed through a computer-generated sequence, and serial and opaque with sealed envelopes will be prepared in by independent staff not involved in clinical care or screening or assessment, in which will be used to conceal the sequence until the intervention as assigned at the outpatient preoperative clinic. A single blinded with outcome assessor will be conducted in both groups.
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
- •diagnosis of colorectal-related cancer
- •scheduled for elective colorectal cancer surgery as primary treatment
- •aged 18 years or above
- •expected surgery date more than 21 days
- •able to collaborate in the study and sign the informed consent
- •able to use WhatsApp application
排除标准
- •identified or known premorbid, that inability to follow the programme
- •able to understand written and spoken Cantonese/ Chinese
研究组 & 干预措施
WhatsApp-assisted prehabilitation
Patient will receive WhatsApp-assisted prehabilitation plus standard care
干预措施: Intervention (Other)
WhatsApp-assisted prehabilitation
Patient will receive WhatsApp-assisted prehabilitation plus standard care
干预措施: Standard care (Other)
Standard care
结局指标
主要结局
Postoperative complications
时间窗: Postoperative period: assessed up to first year postoperative
measured by the Comprehensive Complication Index (CCI), which integrates in a single formula all complications by severity, ranging from 0 (uneventful course) to 100 (death).
次要结局
- Length of hospital stay (LOS)(Postoperative period: assessed up to the first year postoperative)
- Physical activity(Assessments at baseline, weekly before the surgery and on the day of discharge: assess up to first year postoperative)
- Gastrointestinal recovery(Postoperative period: assessed up to 30 days postoperative)
- Gastrointestinal function(Postoperative period: assess up to 30 days postoperative)
- Anxiety and depression(Assessments at baseline and on the day of discharge: assess up to first year postoperative)
- Quality of health-related life(Assessments at baseline and on the day of discharge: assess up to first year postoperative)
研究者
SUNG HOI LING SHERING
Principal Investigator
Tseung Kwan O Hospital, Hong Kong