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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05608967
Acronym
PREHAPP
Enrollment
58
Registered
2022-11-08
Start date
2021-10-01
Completion date
2024-09-26
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mHealth, Prehabilitation, Usability

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.

Interventions

DEVICEPREHapp

Prehabilitation programme through the PREHapp platform

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Usability2 yearEvaluate 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

MeasureTime frameDescription
Functional recovery2 yearEstimate the effect of the prehabilitation with app on functional recovery measured with the 6-minute walk test.
Complications2 yearEvaluate complications during the postoperative period after 4 weeks of follow-up: clavien-dindo classification

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026