PrehabilitationNCT05887531
Abdominopelvic Cancer Prehabilitation
A study testing Prehabilitation in people with Prehabilitation and Cancer of Colon, run by Universitat Jaume I at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Prehabilitation, Cancer of Colon, Cancer of Rectum
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 10 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Prehabilitation, Cancer of Colon, Cancer of Rectum, Cancer, Ovarian
- Being tested
- Prehabilitation
- Keywords
- Selfcare, Fisical exercice, Prehabilitation
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Patients will be included in a prehabilitation program
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation | Experimental | Not described Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: until 4 weeks from surgery
Secondary outcomes (5)
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.
Measured: before surgery
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.
Measured: before surgery
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.
Measured: before surgery
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.
Measured: before surgery
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.
Measured: before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jun 2023
- Primary completion1 Jul 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Pilar Suárez Alcázar, Universitat Jaume I
- Investigators
- Suárez María Pilar, Principal investigator, Universitat Jaume I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887531
- Sponsor's protocol ID
- malcazar
- Status last verified
- Jan 2025
- First submitted
- 15 May 2023
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Prehabilitation Consultation in Self-care and Physical Exercise in Patients Diagnosed With Abdominopelvic Cancer
- ClinicalTrials.gov ID
- NCT05887531
- Acronym / sponsor ID
- malcazar
- Conditions
- Prehabilitation, Cancer of Colon, Cancer of Rectum, Cancer, Ovarian
- Keywords
- Selfcare, Fisical exercice, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation | Experimental | Other: Prehabilitation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationPatients will be included in a prehabilitation program | Other | Prehabilitation |
Primary outcome
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.
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.
5 secondary outcomes
Self-care capacity
Time frame: before surgery
Anxiety levels
Time frame: before surgery
Aerobic capacity
Time frame: before surgery
Flexibility
Time frame: before surgery
Strength
Time frame: before surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suárez María Pilar principal investigator
Universitat Jaume I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Prehabilitation and Cancer of Colon, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-surgical recovery time (time frame: More than 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.