NCT05851235

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

March 22, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 9, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

May 9, 2023

Status Verified

March 1, 2023

Enrollment Period

5 months

First QC Date

March 22, 2023

Last Update Submit

May 5, 2023

Conditions

Colo-rectal Cancer

Keywords

Prehabilitation

Outcome Measures

Primary Outcomes (1)

  • Percentage of eligible participants completed the personalized proposed prehabilitation program

    The primary endpoint of the study will be the feasibility of delivering a prehabilitation program, based on adherence. This study will be deemed as feasible if ≥80% of eligible participants completed the personalized proposed prehabilitation program.

    4 months

Secondary Outcomes (6)

  • Adherence to prescription

    4 months

  • 30-days mortality

    30 days after the surgery

  • Overall morbidity rate and major morbidity rate

    4 months

  • Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery

    30 days after the surgery

  • Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.

    30 days after the surgery

  • +1 more secondary outcomes

Study Arms (1)

Colorectal cancer patients

EXPERIMENTAL

Patients with colon or rectal cancer awaiting surgery

Other: Prehabilitation course

Interventions

Prehabilitation courseOTHER

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

Colorectal cancer patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Clinical need for emergency intervention.
  • Severe cognitive impairment (MMSE\<20\*)
  • Severe dependency (ADL\<3)
  • Stage IV colorectal neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUSL della Romagna

Ravenna, RA, 48100, Italy

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Isacco Montroni, MD

    AUSL della Romagna

    STUDY CHAIR

Central Study Contacts

Isacco Montroni, MD

CONTACT

0544 285111isacco.montroni@auslromagna.it

Centro di Coordinamento

CONTACT

0544 287173cc.ubsc@irst.emr.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2023

First Posted

May 9, 2023

Study Start

March 22, 2023

Primary Completion

September 1, 2023

Study Completion

March 1, 2024

Last Updated

May 9, 2023

Record last verified: 2023-03

Locations

IT(1)