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

Recruiting

• Conditions: Prehabilitation; mHealth; Usability
• Interventions: Device: PREHapp

• Registration Number: NCT05608967
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-10-10
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-04
• Last Update Submitted: 2022-11-04
• Study First Posted: 2022-11-08
• Last Update Posted: 2022-11-08
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
G_PREHapp	PREHapp	Experimental group will follow a prehabilitation programme through the PREHapp platform

Primary Outcome Measures

Name	Time	Method
Usability	2 year	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain