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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prehabilitation, mHealth, Usability

Intervention / Treatment
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* Device: PREHapp


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| G_PREHapp<br>Experimental group will follow a prehabilitation programme through the PREHapp platform | Device: PREHapp<br>* Prehabilitation programme through the PREHapp platform<br>|
| G_Control<br>Control group will follow a prehabilitation programme according to usual practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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