Clinical trial · Interventional
Patient-centered REhabilitation Program to Advance REcovery
A Patient-centered Prehabilitation Program to Enhance Postoperative Recovery in Patients With Malignant Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Frailty | — | UNRESOLVED | — |
| Prehabilitation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| App-based prehabilitation program | Behavioral | — | UNRESOLVED |
| Usual care (ERAS-standard perioperative care) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RH group
- description
- Participants receive an app-based, patient-centered prehabilitation program from randomization until surgery (no extra clinic visits). The program includes weekly home six-minute walk tests (6MWT) logged in the app, brief daily check-ins (exercise performed, simple nutrition targets, mood/stress), push reminders, and short educational video/handout content. Safety prompts and validity checks (continuous 6 minutes, pause limits, outlier flags) are embedded in the app. All on-site assessments are aligned with routine care: preoperative-day in-hospital testing (primary 6MWD, plus grip/TUG/HADS; InBody via fee-free pathway where available) and one routine postoperative outpatient visit (3 or 6 months; site-standard) for follow-up secondary measures. Usual perioperative care is provided per site ERAS practice.
- interventionNames
- Behavioral: App-based prehabilitation program
- type
- ACTIVE_COMPARATOR
- label
- UC group
- description
- Participants receive standard perioperative care per each site's ERAS-consistent routine (preoperative counseling/education, routine mobilization). No study app is provided and no remote 6MWT logging is required. For outcomes collection only, participants undergo the same preoperative-day in-hospital assessment (primary 6MWD, plus grip/TUG/HADS; InBody via fee-free pathway where available) and one routine postoperative outpatient visit (3 or 6 months; site-standard). No additional study-specific clinic visits are required.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available