A Patient-centered Prehabilitation Program to Enhance Postoperative Recovery in Patients With Malignant Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Six-Minute Walk Distance (6MWD)
研究概览
简要总结
The goal of this clinical trial is to learn whether an app-based, patient-centered prehabilitation program improves preoperative functional capacity in adults scheduled for elective cancer surgery. The main questions it aims to answer are:
Does the program increase the six-minute walk distance (6MWD) measured on the preoperative day (within 24-48 hours before surgery)?
Compared with usual care, does the program improve preoperative adherence to home 6MWT practice and patient-reported anxiety/depression (HADS)?
Researchers will compare an app-based prehabilitation program to usual care to see if the program improves preoperative functional capacity.
Participants will:
Use a study app to perform weekly home six-minute walk tests (6MWT) and complete brief daily check-ins (exercise, nutrition, psychological status) before surgery.
Attend routine preoperative admission (no extra visit) for in-hospital 6MWT (primary endpoint) and brief assessments (grip strength, Timed Up & Go, HADS, skeletal muscle mass by InBody where available/fee-free).
Attend one routine postoperative outpatient visit at 3 or 6 months (site-standard timing) for follow-up assessments.
No additional study-specific clinic visits are required outside usual care.
详细描述
Overview and Rationale This multicenter, pragmatic, parallel-group randomized trial evaluates a minimal-cost, app-based, patient-centered prehabilitation program for adults undergoing elective cancer surgery. The intervention focuses on home feasibility and adherence without additional clinic visits. The single prespecified primary endpoint is defined in the Outcome Measures module. Secondary measures are collected with low or no cost (research staff-administered functional tests, app surveys/logs, and fee-free body composition where available). The design reflects three principles: (i) patient self-management supported by simple digital tools, (ii) multimodal content (exercise, nutrition, psychological support), and (iii) streamlined follow-up aligned with routine care.
Study Design and Setting Randomized (1:1), parallel assignment, open-label; outcome assessors for in-hospital functional testing will be masked when feasible. Three university hospitals participate under a common SOP and centralized coordination. Total planned enrollment is 60 participants.
Interventions
App-based prehabilitation (Experimental): Participants receive access to a lightweight mobile/web app that provides weekly prompts to perform a home six-minute walk test (6MWT), brief daily check-ins (exercise performed, simple nutrition targets, mood/stress), push reminders, and basic guidance content. The app logs attempts, completion, and distance input (or pedometer/GPS-assisted estimate when available) and allows secure CSV export for analysis.
Usual care (Control): Standard perioperative education and care per site ERAS practice; no study app.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years.
- •Elective cancer surgery planned under general anesthesia at a participating site (e.g., gastrointestinal, hepatobiliary-pancreatic, thoracic, gynecologic, or other site-approved cancer operations).
- •Ambulatory: able to walk independently (assistive device such as a cane is allowed) and deemed safe to perform a six-minute walk test (6MWT) per investigator judgment.
- •Smartphone access and app use: owns/has regular access to a smartphone capable of running the study app and agrees to use the app (notifications, weekly home 6MWT logging, brief daily check-ins).
- •Preoperative lead-in: expected interval of ≈14 days or more between consent/randomization and surgery to allow prehabilitation exposure (shorter intervals may be screened but must allow minimum onboarding and at least one home 6MWT).
- •Able to understand study procedures and provide written informed consent (Korean or English literacy sufficient to follow app instructions).
排除标准
- •Emergency surgery or surgery date that cannot accommodate even minimal prehabilitation onboarding.
- •ASA IV or higher, or any unstable/critical condition that, in the investigator's opinion, makes participation unsafe.
- •Contraindications to 6MWT/light walking, including but not limited to: unstable angina, recent myocardial infarction (≤30 days), decompensated heart failure, uncontrolled clinically significant arrhythmia, severe symptomatic aortic stenosis, severe uncontrolled pulmonary disease, or investigator-judged safety concerns (e.g., resting severe hypoxemia, high fall risk).
- •Non-ambulatory status or musculoskeletal/neurologic conditions that preclude performing a 6MWT.
- •Cognitive impairment or psychiatric/behavioral conditions that preclude informed consent or reliable app use.
- •Inability or unwillingness to install/use the study app (or lack of regular smartphone access).
- •Concurrent enrollment in another interventional clinical trial that would confound outcomes or burden participants (per investigator judgment).
- •Any other medical or logistical condition that, in the opinion of the investigator, would interfere with protocol adherence, outcome assessment on the preoperative day, or the routine postoperative follow-up visit.
结局指标
主要结局
Six-Minute Walk Distance (6MWD)
时间窗: Preoperative day (within 24-48 hours before surgery)
Distance in meters covered during a standardized six-minute walk test (6MWT) performed in hospital on the preoperative day. Testing follows ATS-aligned instructions on a marked indoor course (\~30 m). Trained staff administer the test and are blinded to group allocation when feasible. The primary endpoint is the absolute distance (meters) on the preoperative day; baseline/home 6MWT collected via the app may be used as a covariate but is not part of the primary measure. Safety prompts (stop for chest pain, severe dyspnea, presyncope) are embedded in the SOP.
次要结局
- Hospital Anxiety and Depression Scale (HADS), change(Preoperative day (within 24-48 hours before surgery))
- Grip strength, change(Preoperative day (within 24-48 hours before surgery))
- Timed Up & Go (TUG), change(Preoperative day (within 24-48 hours before surgery))
- Skeletal muscle mass index (SMI), change(Preoperative day (within 24-48 hours before surgery))
- App-logged home 6MWT adherence (preoperative period)(From enrollment to preoperative day (1 day before surgery))
- Postoperative complications within 30 days(postoperative day 30)
- hospital length of stay(through study completion, an average of 1 year)
- 30-day readmission(postoperative day 30)
研究者
Eunji Ko
Clinical Assistant Professor
Korea University Anam Hospital