Abdominopelvic Cancer Prehabilitation

Sponsor
Universitat Jaume I (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05887531
Collaborator
(none)
66
1
16.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prehabilitation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Effectiveness of a Prehabilitation Consultation in Self-care and Physical Exercise in Patients Diagnosed With Abdominopelvic Cancer
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Oct 10, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prehabilitation

Other: Prehabilitation
Patients will be included in a prehabilitation program

Outcome Measures

Primary Outcome Measures

  1. Post-surgical recovery time [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.

  2. Post-surgical readmisions [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.

Secondary Outcome Measures

  1. Self-care capacity [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.

  2. Anxiety levels [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.

  3. Aerobic capacity [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.

  4. Flexibility [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.

  5. Strength [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universitat Jaume I

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
María Pilar Suárez Alcázar, Principal Investigator, Universitat Jaume I
ClinicalTrials.gov Identifier:
NCT05887531
Other Study ID Numbers:
  • malcazar
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by María Pilar Suárez Alcázar, Principal Investigator, Universitat Jaume I
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023