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NOT YET RECRUITING

NCT07189000

Patient-centered REhabilitation Program to Advance REcovery

Sponsor: Korea University Anam Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Patient-centered Prehabilitation Program to Enhance Postoperative Recovery in Patients With Malignant Cancer

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2025-09-23

Healthy Volunteers

Conditions

Cancer Frailty Prehabilitation

Interventions

BEHAVIORAL

App-based prehabilitation program

A lightweight mobile/web application delivering a patient-centered prehabilitation program from randomization until surgery. Features include: weekly home six-minute walk tests (6MWT) logged in the app; brief daily check-ins for exercise performed, simple nutrition targets, and mood/stress; push reminders; short educational video/handout content; and CSV export for analysis. The app provides standardized instructions and safety prompts for the home 6MWT and basic validity checks (continuous 6 minutes, pause limits, outlier flags). No additional study-specific clinic visits are required beyond routine preoperative admission and one routine postoperative outpatient visit.

OTHER

Usual care (ERAS-standard perioperative care)

Standard perioperative counseling/education and routine mobilization per institutional ERAS practice. No study app is provided and no remote 6MWT logging is required. Outcome assessments are collected at routine preoperative admission (including in-hospital 6MWT per protocol) and at one routine postoperative outpatient visit (≈3 or 6 months per unified site policy). No additional study-specific clinic visits are required.

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.

Locations (1)

Korea University Anam Hospital

Seoul, South Korea