An interventional study of Prehabilitation course in Colo-rectal Cancer, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Status unknown at 1 site in Italy. Open to participants aged 70 Years and older. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Not applicable, Interventional, and Other
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:
The prehabilitation course is structured around the following aspects:
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 25 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS is the lead sponsor of 59 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
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.
Time frame: 4 months
Adherence to prescription
Percentage of patients with compliance greater than 80% to prehabilitation prescription
Time frame: 4 months
30-days mortality
Proportion of patients who died for all causes within 30 days after the surgery
Time frame: 30 days after the surgery
Overall morbidity rate and major morbidity rate
Calculated according Clavien-Dindo classification
Time frame: 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).
Time frame: 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).
Time frame: 30 days after the surgery
Postoperative functional recovery at one month after surgery
Percentage of patients experiences functional recovery as described in protocol.
Time frame: 30 days after the surgery
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS