Prehabilitation in Geriatric Patients With Colorectal Neoplasia

Not Applicable

Recruiting

• Conditions: Colo-rectal Cancer
• Interventions: Other: Prehabilitation course

• Registration Number: NCT05851235
• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-22
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-05-05
• Last Update Submitted: 2023-05-05
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2023-09
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colorectal cancer patients	Prehabilitation course	Patients with colon or rectal cancer awaiting surgery

Primary Outcome Measures

Name	Time	Method
Percentage of eligible participants completed the personalized proposed prehabilitation program	4 months	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.

Secondary Outcome Measures

Name	Time	Method
30-days mortality	30 days after the surgery	Proportion of patients who died for all causes within 30 days after the surgery
Postoperative functional recovery at one month after surgery	30 days after the surgery	Percentage of patients experiences functional recovery as described in protocol.
Adherence to prescription	4 months	Percentage of patients with compliance greater than 80% to prehabilitation prescription
Overall morbidity rate and major morbidity rate	4 months	Calculated according Clavien-Dindo classification
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery	30 days after the 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).
Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.	30 days after the 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).

Trial Locations

Locations (1)

AUSL della Romagna; 🇮🇹 Ravenna, RA, Italy