Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT05608967
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-11-04', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Usability', 'timeFrame': '2 year', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Functional recovery', 'timeFrame': '2 year', 'description': 'Estimate the effect of the prehabilitation with app on functional recovery measured with the 6-minute walk test.'}, {'measure': 'Complications', 'timeFrame': '2 year', 'description': 'Evaluate complications during the postoperative period after 4 weeks of follow-up: clavien-dindo classification'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prehabilitation', 'mHealth', 'Usability']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than or equal to 18 years.\n* Diagnosis of resectable colon cancer with elective surgery.\n* Participants have at least 2 weeks to their operation date.\n* Agree to collaborate in the study and sign the informed consent\n\nExclusion Criteria:\n\n* Diagnosis of unresectable colon cancer.\n* Inability to follow the prehabilitation programme.\n* Participants be able to understand written and spoken Spanish.\n* Subjects with previous nutritional supplements.\n* Pre-anesthetic evaluation with results, according to the classification of the American Society of Anesthesiologists (ASA) IV or V.'}, 'identificationModule': {'nctId': 'NCT05608967', 'acronym': 'PREHAPP', 'briefTitle': 'Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}, 'officialTitle': 'PREHapp Study Protocol: Effect of a Prehabilitation Mobile Application Versus Standard of Care Before Colon Cancer Surgery: a Randomized Pilot Study', 'orgStudyIdInfo': {'id': 'PREHAPP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'G_PREHapp', 'description': 'Experimental group will follow a prehabilitation programme through the PREHapp platform', 'interventionNames': ['Device: PREHapp']}, {'label': 'G_Control', 'description': 'Control group will follow a prehabilitation programme according to usual practice'}], 'interventions': [{'name': 'PREHapp', 'type': 'DEVICE', 'description': 'Prehabilitation programme through the PREHapp platform', 'armGroupLabels': ['G_PREHapp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03203', 'city': 'Elche', 'state': 'Alicante', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Luis Sánchez Guillén, MD', 'role': 'CONTACT'}, {'name': 'Cristina Lillo García', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario de Elche', 'geoPoint': {'lat': 38.26218, 'lon': -0.70107}}], 'centralContacts': [{'name': 'Cristina Lillo García', 'role': 'CONTACT', 'email': 'clillo.cir@gmail.com', 'phone': '966616900'}, {'name': 'Luis Sánchez Guillén', 'role': 'CONTACT', 'phone': '966616900'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Staff Colorectal Surgeon', 'investigatorFullName': 'Luis Sánchez Guillen', 'investigatorAffiliation': 'Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana'}}}}