NCT05887531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2024

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

May 15, 2023

Last Update Submit

January 28, 2025

Conditions

Keywords

SelfcareFisical exercicePrehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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.

    More than 2 days

  • 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.

    until 4 weeks from surgery

Secondary Outcomes (5)

  • Self-care capacity

    before surgery

  • Anxiety levels

    before surgery

  • Aerobic capacity

    before surgery

  • Flexibility

    before surgery

  • Strength

    before surgery

Study Arms (1)

Prehabilitation

EXPERIMENTAL
Other: Prehabilitation

Interventions

Patients will be included in a prehabilitation program

Prehabilitation

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsOvarian Neoplasms

Interventions

Preoperative Exercise

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Perioperative CarePatient CareTherapeuticsSurgical Procedures, OperativeExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Suárez María Pilar

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2023

First Posted

June 2, 2023

Study Start

June 1, 2023

Primary Completion

July 1, 2024

Study Completion

October 10, 2024

Last Updated

January 29, 2025

Record last verified: 2025-01

Locations