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

NCT05608967 | Unknown

• 1 other identifier: PREHAPP
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prehabilitation; mHealth; Usability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Functional recovery

  2 year

• Complications

  2 year

Study Arms (2)

G_PREHapp

Experimental group will follow a prehabilitation programme through the PREHapp platform

Device: PREHapp

G_Control

Control group will follow a prehabilitation programme according to usual practice

Interventions

PREHapp DEVICE

Prehabilitation programme through the PREHapp platform

G_PREHapp

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

RECRUITING

Central Study Contacts

Cristina Lillo García

CONTACT

966616900; clillo.cir@gmail.com

Luis Sánchez Guillén

CONTACT

966616900

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Staff Colorectal Surgeon

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: November 8, 2022
• Study Start: September 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)