Abdominopelvic Cancer Prehabilitation

June 13, 2023 updated by: María Pilar Suárez Alcázar, Universitat Jaume I

Effectiveness of a Prehabilitation Consultation in Self-care and Physical Exercise in Patients Diagnosed With Abdominopelvic Cancer

The main objective of this research is to determine the effectiveness of a Prehabilitation consultation in self-care and physical exercise aimed at patients diagnosed with abdominopelvic cancer with initial surgical indication as part of their therapeutic plan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Suárez María Pilar
  • Phone Number: +34 964387804
  • Email: malcazar@uji.es

Study Contact Backup

  • Name: Collado-Boira Eladio
  • Phone Number: +34 606133368
  • Email: colladoe@uji.es

Study Locations

  • Spain
    • Castellón
      • Castellón De La Plana, Castellón, Spain, 12071
        • Recruiting
        • Universitat Jaume I
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Majority (greater than or equal to 18 years).
  • Diagnosis of abdominopelvic cancer and initial surgical indication as part of its therapeutic plan from the General Surgery Services of the General University Hospital of Castellón.
  • Ability to give informed consent.

Exclusion Criteria:

  • Inability to understand the information provided or insufficient knowledge of the Spanish language.
  • Inability to carry out the scheduled intervention according to the physician's criteria.
  • Neoadjuvant treatment to colorectal surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prehabilitation
Other: Prehabilitation
Patients will be included in a prehabilitation program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical recovery time
Time Frame: More than 2 days
To determine if there is a reduction in post-surgical recovery time until the start of adjuvant therapy in patients with abdominopelivoc cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise.
More than 2 days
Post-surgical readmisions
Time Frame: until 4 weeks from surgery
To determine if there is a reduction in the number of readmisions in patients with abdominopelvic cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise.
until 4 weeks from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels
Time Frame: before surgery
To establish whether there is a decrease in preoperative anxiety levels mesured by Hospital Anxiety and Depression Scale in patients with abdominopelvic cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise.
before surgery
Strength
Time Frame: before surgery
To determine if there is an improvement strength mesured by hand grip in patients with abdominopelvic cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise.
before surgery
Self-care capacity
Time Frame: before surgery
To know if there is an improvement in the self-care capacity mesured by the Appraisal of Self-care Agency Scale (ASA) scale in patients with abdominopelvic cancer after their incorporation into the Pre-habilitation program in self-care and directed physical exercise. Minimum value: 24 y Maximum value: 96. Higher scores mean a better outcomes.
before surgery
Aerobic capacity
Time Frame: before surgery
To determine if there is an improvement in aerobic capacity mesured by walking test in patients with abdominopelvic cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise. Higher scores mean a better outcomes.
before surgery
Flexibility
Time Frame: before surgery
To determine if there is an improvement flexibility mesured by set and reach test in patients with abdominopelvic cancer after their incorporation into the Prehabilitation program in self-care and directed physical exercise. Higher scores mean a better outcomes.
before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Investigators

  • Principal Investigator: Suárez María Pilar, Universitat Jaume I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

October 10, 2024

Study Registration Dates

First Submitted

May 15, 2023

First Submitted That Met QC Criteria

May 24, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • malcazar

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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