Patient-centered REhabilitation Program to Advance REcovery

NCT07189000 | Not Yet Recruiting

• 1 other identifier: PREPARE-CAN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Frailty; Prehabilitation

Keywords

prehabilitation; frailty; cancer

Outcome Measures

Primary Outcomes (1)

• Six-Minute Walk Distance (6MWD)

  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.

  Preoperative day (within 24-48 hours before surgery)

Secondary Outcomes (8)

• 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)

Other Outcomes (1)

• App daily check-in completion (preoperative period)

  From enrollment to preoperative day (1 day before surgery)

Study Arms (2)

RH group

EXPERIMENTAL

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.

Behavioral: App-based prehabilitation program

UC group

ACTIVE COMPARATOR

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.

Other: Usual care (ERAS-standard perioperative care)

Interventions

App-based prehabilitation program BEHAVIORAL

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.

RH group

Usual care (ERAS-standard perioperative care) OTHER

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.

UC group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Neoplasms; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Eunji Ko, M.D., Ph.D.

CONTACT

+82-10-3423-8249; froken.ko@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

KR (1)