Prehabilitation in Geriatric Patients With Colorectal Neoplasia (PIGEON)

Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia

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

Study Overview

• Status: Recruiting
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: Other: Prehabilitation course

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isacco Montroni, MD; Phone Number: 0544 285111; Email: isacco.montroni@auslromagna.it
• Study Contact Backup: Name: Centro di Coordinamento; Phone Number: 0544 287173; Email: cc.ubsc@irst.emr.it

Study Locations

• Italy
  • RA
    • Ravenna, RA, Italy, 48100
      • Recruiting
      • AUSL della Romagna
      • Contact: Isacco Montroni, MD; Email: isacco.montroni@auslromagna.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colorectal cancer patients; Patients with colon or rectal cancer awaiting surgery	Other: Prehabilitation course; During prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to prescription	Percentage of patients with compliance greater than 80% to prehabilitation prescription	4 months
30-days mortality	Proportion of patients who died for all causes within 30 days after the surgery	30 days after the surgery
Overall morbidity rate and major morbidity rate	Calculated according Clavien-Dindo classification	4 months
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery	Questionnaire EQ-5D-3L. Test results are presented in the form of an index and a VAS scale. The index is based on patients' quality of life in 5 domains across 3 levels. Distribution of EQ-5D-3L dimension responses at different times were calculated. The index, which is a value attached to an EQ-5D-3L profile according to a set of weights that reflect, on average, people's preferences about how good or bad the state is, ranges from 0 (poorest quality of life) to 1 (perfect health). The value set generated from the European population (EQ) was used as the reference cohort for index calculation. The VAS score is generated by asking the patient how he/she ranked his/her QoL, as compared to his/her peers, on a scale from 0 to 100, where higher values were associated to a better quality of life. EQ-5D-3L index and VAS were expressed as mean (Standard Deviation-SD) and median (minimum-maximum), while frequency will be calculated for categorical variables (five domains of EQ-5D-3L).	30 days after the surgery
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.	Questionnaire EORTC QLQ-ELD14, a questionnaire that comprise five scales (mobility, worries about others, future worries, maintaining purpose and burden of illness) and two single items (joint stiffness and family support). Four levels were available for the response (1=not at all, 2=a little, 3=quite a bit, 4=very much). Distribution of EORTC QLQ-ELD14 items at different times were calculated. All scale and item scores are transformed to a 0-100 scale, higher scores representing a worse outcome except for maintaining purpose and family support. EORTC QLQ-ELD14 scores were expressed as mean (Standard Deviation-SD) and median (minimum-maximum), while frequency will be calculated for categorical variables (for the five scales and two single items).	30 days after the surgery
Postoperative functional recovery at one month after surgery	Percentage of patients experiences functional recovery as described in protocol.	30 days after the surgery

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Collaborators: Istituto Oncologico Romagnolo (IOR)
• Investigators: Study Chair: Isacco Montroni, MD, AUSL della Romagna

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 5, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Prehabilitation
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: IRST153.08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No