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Completed

NCT Number: NCT05608967

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

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.

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Key information

Conditions

Prehabilitation Usability mHealth

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PREHapp

Device

Prehabilitation programme through the PREHapp platform

Primary outcomes

  1. Usability

    Time frame: 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 outcomes

  1. Functional recovery

    Time frame: 2 year

    Estimate the effect of the prehabilitation with app on functional recovery measured with the 6-minute walk test.

  2. Complications

    Time frame: 2 year

    Evaluate complications during the postoperative period after 4 weeks of follow-up: clavien-dindo classification

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PREHAPP

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2022
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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