Clinical trial NCT05851235: Prehabilitation in Geriatric Patients With Colorectal Neoplasia
Official title: Results of a Programme of Intensive Prehabilitation in GEriatric Patients Operated for Colo-Rectal Neoplasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colo-rectal Cancer
Keywords: Prehabilitation
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
Collaborators: name: Istituto Oncologico Romagnolo (IOR)
First posted: 2023-05-09
Enrollment: 25
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of eligible participants completed the personalized proposed prehabilitation program
timeFrame: 4 months
Secondary outcomes:
measure: Adherence to prescription
timeFrame: 4 months
measure: 30-days mortality
timeFrame: 30 days after the surgery
measure: Overall morbidity rate and major morbidity rate
timeFrame: 4 months
measure: Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery
timeFrame: 30 days after the surgery
measure: Preservation/improvement of pre-operative quality of life before vs. 1-month after surgery.
timeFrame: 30 days after the surgery
measure: Postoperative functional recovery at one month after surgery
timeFrame: 30 days after the surgery
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: AUSL della Romagna
state: RA
Study officials:
affiliation: AUSL della Romagna
name: Isacco Montroni, MD
role: STUDY_CHAIR
References: