Back to resultsAbdominopelvic Cancer Prehabilitation
Primary Purpose
Prehabilitation, Cancer of Colon, Cancer of Rectum
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Prehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Prehabilitation focused on measuring Selfcare, Fisical exercice, Prehabilitation
Eligibility Criteria
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.
Sites / Locations
- Universitat Jaume IRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Post-surgical recovery time
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.
Post-surgical readmisions
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.
Secondary Outcome Measures
Self-care capacity
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.
Anxiety levels
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.
Aerobic capacity
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.
Flexibility
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.
Strength
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05887531
Brief Title
Abdominopelvic Cancer Prehabilitation
Official Title
Effectiveness of a Prehabilitation Consultation in Self-care and Physical Exercise in Patients Diagnosed With Abdominopelvic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
October 10, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Jaume I
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehabilitation, Cancer of Colon, Cancer of Rectum, Cancer, Ovarian
Keywords
Selfcare, Fisical exercice, Prehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Prehabilitation
Intervention Description
Patients will be included in a prehabilitation program
Primary Outcome Measure Information:
Title
Post-surgical recovery time
Description
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.
Time Frame
More than 2 days
Title
Post-surgical readmisions
Description
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.
Time Frame
until 4 weeks from surgery
Secondary Outcome Measure Information:
Title
Self-care capacity
Description
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.
Time Frame
before surgery
Title
Anxiety levels
Description
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.
Time Frame
before surgery
Title
Aerobic capacity
Description
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.
Time Frame
before surgery
Title
Flexibility
Description
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.
Time Frame
before surgery
Title
Strength
Description
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.
Time Frame
before surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Suárez María Pilar
Phone
+34 964387804
Email
malcazar@uji.es
First Name & Middle Initial & Last Name or Official Title & Degree
Collado-Boira Eladio
Phone
+34 606133368
Email
colladoe@uji.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suárez María Pilar
Organizational Affiliation
Universitat Jaume I
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitat Jaume I
City
Castellón De La Plana
State/Province
Castellón
ZIP/Postal Code
12071
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suárez María Pilar
Phone
+34 964387804
Email
malcazar@uji.es
First Name & Middle Initial & Last Name & Degree
Collado-Boira Eladio
Phone
+34 606 133368
Email
colladoe@uji.es
12. IPD Sharing Statement
Learn more about this trial
Abdominopelvic Cancer Prehabilitation
We'll reach out to this number within 24 hrs