Prehabilitation in Geriatric Patients With Colorectal Neoplasia

NCT ID: NCT05851235

Last Updated: 2023-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-03-31

Brief Summary

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This an interventional, non-pharmacologic study. Prehabilitation is a multidisciplinary preoperative intervention aimed at preventing or reducing functional decline related to surgery and improving perioperative outcomes. The current study is aimed at standardizing a prehabilitation pathway, evaluating its feasibility within the AUSL Romagna in collaboration with the PRIME Centre and the multiple professions that populate the two institutes in the spirit of confirming the beneficial effect of an integrated prehabilitation programme on surgical outcomes.

Patients will follow an intensive prehabilitation course before surgery:

* Colon cancer patients will do 4 weeks of prehabilitation before surgery.
* Rectal cancer patients will do 12 weeks of prehabilitation after neoadjuvant therapy and before surgery.

The prehabilitation course is structured around the following aspects:

* Frailty assessment and identification of optimisation fields
* Optimisation of modifiable factors (anaemia, polypharmacotherapy, smoking, alcoholism, diabetes)
* Assessment by an integrative medicine specialist
* Nutritional pre-qualification
* Cardiovascular, respiratory, motor prehabilitation
* Emotional and psychological prehabilitation

Detailed Description

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Conditions

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Colo-rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Colorectal cancer patients

Patients with colon or rectal cancer awaiting surgery

Group Type EXPERIMENTAL

Prehabilitation course

Intervention Type OTHER

During prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme.

Interventions

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Prehabilitation course

During prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
2. Male/female participants who are at least 70 years of age on the day of signing informed consent.
3. Patients with confirmed diagnosis of colorectal cancer awaiting major surgery.

Exclusion Criteria

1. Clinical need for emergency intervention.
2. Severe cognitive impairment (MMSE\<20\*)
3. Severe dependency (ADL\<3)
4. Stage IV colorectal neoplasia
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Oncologico Romagnolo (IOR)

UNKNOWN

Sponsor Role collaborator

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Isacco Montroni, MD

Role: STUDY_CHAIR

AUSL della Romagna

Locations

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AUSL della Romagna

Ravenna, RA, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Isacco Montroni, MD

Role: CONTACT

0544 285111

Centro di Coordinamento

Role: CONTACT

0544 287173

Facility Contacts

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Isacco Montroni, MD

Role: primary

Other Identifiers

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IRST153.08

Identifier Type: -

Identifier Source: org_study_id

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