PrehabilitationPREHAPPNCT05608967
Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.
An observational study of Prehabilitation and mHealth, run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehabilitation, mHealth, Usability
- What is being tested?
- PREHapp
- Type of treatment
- Medical device
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 26 Sep 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PREHapp Study Protocol: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery: a Randomized Pilot Study
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
- Being tested
- PREHapp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREHappDevice
Prehabilitation programme through the PREHapp platform
| Study group | Role | What they receive |
|---|---|---|
| G_PREHapp | Experimental group will follow a prehabilitation programme through the PREHapp platform Receives: Device: PREHapp | |
| G_Control | Control group will follow a prehabilitation programme according to usual practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 year
Secondary outcomes (2)
Functional recovery
Estimate the effect of the prehabilitation with app on functional recovery measured with the 6-minute walk test.
Measured: 2 year
Complications
Evaluate complications during the postoperative period after 4 weeks of follow-up: clavien-dindo classification
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start1 Oct 2021
- Primary completion26 Aug 2024
- Study completion26 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Sánchez Guillen, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608967
- Sponsor's protocol ID
- PREHAPP
- Acronym
- PREHAPP
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2022
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No