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

Prehabilitation Clinical Trial

— PREHAPP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05608967
• Other study ID #: PREHAPP
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
• Contact: Cristina Lillo García
• Phone: 966616900
• Email: clillo.cir[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms
• mHealth
• Prehabilitation
• Usability

Intervention

Device:
• PREHapp
Prehabilitation programme through the PREHapp platform

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Elche	Elche	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Country where clinical trial is conducted

Spain, 

Outcome

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