Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery. (PREHAPP)

PREHapp Study Protocol: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery: a Randomized Pilot Study

Pilot study to evaluate the effect of prehabilitation programme through a mobile application PREHapp in colon cancer surgery. The objectives of this pilot study were to evaluate the usability of the PREHapp for people undergoing colon cancer surgery, estimate the effect of the app on functional recovery after surgery and to evaluate complications during the postoperative period after 4 weeks of follow-up.

Study Overview

• Status: Recruiting
• Conditions: mHealth; Prehabilitation; Usability
• Intervention / Treatment: Device: PREHapp

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Cristina Lillo García; Phone Number: 966616900; Email: clillo.cir@gmail.com
• Study Contact Backup: Name: Luis Sánchez Guillén; Phone Number: 966616900

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Recruiting
      • Hospital General Universitario de Elche
      • Contact: Luis Sánchez Guillén, MD
      • Principal Investigator: Cristina Lillo García

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population is made up of patients scheduled for colon surgery due to malignant pathology at the General Hospital of Elche. Patients must be 18 years of age or older, have an Android smartphone, and accept the prehabilitation program.

Description

Inclusion Criteria:

• Age greater than or equal to 18 years.
• Diagnosis of resectable colon cancer with elective surgery.
• Participants have at least 2 weeks to their operation date.
• Agree to collaborate in the study and sign the informed consent

Exclusion Criteria:

• Diagnosis of unresectable colon cancer.
• Inability to follow the prehabilitation programme.
• Participants be able to understand written and spoken Spanish.
• Subjects with previous nutritional supplements.
• Pre-anesthetic evaluation with results, according to the classification of the American Society of Anesthesiologists (ASA) IV or V.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
G_PREHapp; Experimental group will follow a prehabilitation programme through the PREHapp platform	Device: PREHapp; Prehabilitation programme through the PREHapp platform
G_Control; Control group will follow a prehabilitation programme according to usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Evaluate the usability of PREHapp with the System Usability Scale (SUS). The SUS is a reliable and valid 10-statement usability scale suitable to assess a wide range of eHealth technologies. The total SUS score ranges from 0 to 100, and higher scores reflect higher usability. An SUS score of at least 62.7 was considered acceptable, and 68 or above was regarded as above average in terms of usability quality	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional recovery	Estimate the effect of the prehabilitation with app on functional recovery measured with the 6-minute walk test.	2 year
Complications	Evaluate complications during the postoperative period after 4 weeks of follow-up: clavien-dindo classification	2 year

Collaborators and Investigators

• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: November 4, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: PREHAPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No