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

NCT ID: NCT05608967

Last Updated: 2022-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prehabilitation mHealth Usability

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

G_PREHapp

Experimental group will follow a prehabilitation programme through the PREHapp platform

PREHapp

Intervention Type DEVICE

Prehabilitation programme through the PREHapp platform

G_Control

Control group will follow a prehabilitation programme according to usual practice

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PREHapp

Prehabilitation programme through the PREHapp platform

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luis Sánchez Guillen

MD, Staff Colorectal Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital General Universitario de Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina Lillo García

Role: CONTACT

966616900

Luis Sánchez Guillén

Role: CONTACT

966616900

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Luis Sánchez Guillén, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PREHAPP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PreColo Practice Variation
NCT03682133 TERMINATED
Enhancing Outcomes After Colon Surgery
NCT00227526 COMPLETED PHASE2