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Prehabilitation program for Colorectal Cancer

N/A

Waitlist Available

Led By Sender Liberman, MD

Research Sponsored by Montreal General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All adult persons scheduled for resection of malignant colorectal lesions will be included

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks before surgery and 4 weeks after the surgery

Awards & highlights

Study Summary

This trial will help to answer the question of whether a multimodal intervention that includes physical exercise can improve sleep quality and duration compared to standard care in the perioperative period.

Eligible Conditions

Colorectal Cancer
Surgery

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks before surgery and 4 weeks after the surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks before surgery and 4 weeks after the surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks before surgery and 4 weeks after the surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pittsburgh Sleep Quality Index (PSQI): "change" is being assessed

Sleep quality by an Actigraphy: "change" is being assessed

Secondary outcome measures

Community Health Activities Model Program for Seniors (CHAMPS) questionnaire: "change" is being assessed

Daily activity counts measured by an Actigraphy: "change" is being assessed

Functional capacity using the six-minute walk test (6MWT): "change" is being assessed

+1 more

Other outcome measures

Anaerobic threshold (AT) measured during cardiopulmonary exercise testing (CPET): "change" is being assessed

CO2 production: "change" is being assessed

Chronotype: "change" is being assessed

+11 more

Trial Design

2Treatment groups

Active Control

Group I: Prehabilitation programActive Control1 Intervention

The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.

Group II: Standard of care (SOC)Active Control1 Intervention

Common to both groups as part of the enhanced recovery after surgery (ERAS) protocol as the standard of care in our institution.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montreal General HospitalLead Sponsor

17 Previous Clinical Trials

9,937 Total Patients Enrolled

Sender Liberman, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

Franco Carli, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre

8 Previous Clinical Trials

585 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in the trial at its maximum capacity?

"Affirmative. According to the posted information on clinicaltrials.gov, this medical trial is still searching for participants who were initially recruited on September 15th 2020 and updated as recently as April 5th 2022. One hundred volunteers are required across one site."

Answered by AI

What aims does this clinical experiment hope to realize?

"This clinical study aims to evaluate the overall improvement of patients' sleep quality as measured by Pittsburgh Sleep Quality Index (PSQI). Secondary objectives include determining changes in functional capacity via six-minute walk test, daily activity counts using Actigraphy, and Hospital Anxiety and Depression Scale. This trial will span over a period of 8 weeks with pre-surgery evaluation comprising 4 weeks and post surgery assessment taking up the remaining four weeks."

Answered by AI

Is this trial open for enrollment?

"The information posted on the clinicaltrials.gov website reveals that this medical trial is actively seeking enrollees, with its inception date being September 15th 2020 and its latest edit occuring April 5th 2022."

Answered by AI

Recent research and studies

British Journal of CancerJournal

The Role of Diet and Physical Activity in Breast, Colorectal, and Prostate Cancer Survivorship: A Review of the Literature

Davies, N J, L Batehup, and R Thomas. 2011. “The Role of Diet and Physical Activity in Breast, Colorectal, and Prostate Cancer Survivorship: A Review of the Literature”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/bjc.2011.423.

Clinical Journal of Oncology NursingJournal

Physical Activity in Patients with Advanced-stage Cancer: A Systematic Review of the Literature

Albrecht, Tara A., and Ann Gill Taylor. 2012. “Physical Activity in Patients with Advanced-stage Cancer: A Systematic Review of the Literature”. Clinical Journal of Oncology Nursing. Oncology Nursing Society (ONS). doi:10.1188/12.cjon.293-300.

Supportive Care in CancerJournal

Relationship Between Sleep and Exercise as Colorectal Cancer Survivors Transition Off Treatment

Coles, Theresa, Antonia V. Bennett, Xianming Tan, Claudio L. Battaglini, Hanna K. Sanoff, Ethan Basch, Roxanne E. Jensen, and Bryce B. Reeve. 2018. “Relationship Between Sleep and Exercise as Colorectal Cancer Survivors Transition Off Treatment”. Supportive Care in Cancer. Springer Science and Business Media LLC. doi:10.1007/s00520-018-4110-8.

Journal of Clinical OncologyJournal