Prehabilitation in Geriatric Patients With Colorectal Neoplasia

Colo-rectal Cancer Clinical Trial

— PIGEON  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851235
• Other study ID #: IRST153.08
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Isacco Montroni, MD
• Phone: 0544 285111
• Email: isacco.montroni[@]auslromagna.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Neoplasms

Intervention

Other:
• Prehabilitation course
During prehabilitation course, patients will follow a nutritional programme, a cardiovascular and motor programme and a psychological programme.

Locations

Country	Name	City	State
Italy	AUSL della Romagna	Ravenna	RA

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori	Istituto Oncologico Romagnolo (IOR)

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adherence to prescription	Percentage of patients with compliance greater than 80% to prehabilitation prescription	4 months
Secondary	30-days mortality	Proportion of patients who died for all causes within 30 days after the surgery	30 days after the surgery
Secondary	Overall morbidity rate and major morbidity rate	Calculated according Clavien-Dindo classification	4 months
Secondary	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
Secondary	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
Secondary	Postoperative functional recovery at one month after surgery	Percentage of patients experiences functional recovery as described in protocol.	30 days after the surgery