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Trimodal Prehabilitation for Colorectal Cancer (PrehabCRC Trial)

N/A

Recruiting

Research Sponsored by Jordan Leitch

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after surgery

Awards & highlights

PrehabCRC Trial Summary

This trial will investigate if prehabilitation (exercise, nutrition & mindfulness coaching) can improve outcomes for CRC patients undergoing major colorectal surgery. Researchers will compare prehab vs. no prehab groups on mortality, length of stay, complications, etc.

Who is the study for?

This trial is for adults aged 18 or older who are scheduled to undergo major surgery for colorectal cancer, such as colectomy, low anterior resection, or abdominoperineal resection. It's not specified who can't join the trial.Check my eligibility

What is being tested?

The study tests a 'trimodal prehabilitation' approach combining exercise, nutrition, and mindfulness coaching before major colorectal surgery. The aim is to see if this method is doable within current care systems and if it improves patient outcomes compared to past patients who didn't get this support.See study design

What are the potential side effects?

Since the interventions involve non-invasive practices like exercise, nutrition guidance, and mindfulness training rather than medications or surgeries, significant side effects are not expected. However, individual experiences may vary.

PrehabCRC Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ four to six weeks prior to surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~four to six weeks prior to surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and four to six weeks prior to 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

Adherence rate

Exercise completion rate

Mindfulness compliance rate

+3 more

Secondary outcome measures

All-cause Mortality

Major complications

Non-home discharge

+2 more

PrehabCRC Trial Design

2Treatment groups

Experimental Treatment

Group I: Progress CheckExperimental Treatment3 Interventions

This arm will include pre- and post-prehabilitation questionnaires as well as twice weekly progress checks by the research assistant to check on participant progress, answer questions and provide accountability and motivation.

Group II: No Progress CheckExperimental Treatment3 Interventions

This arm will include only pre- and post-prehabilitation questionnaires.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness

2014

Completed Phase 3

~2670

Exercise

2016

Completed Phase 1

~760

Nutrition

2011

Completed Phase 3

~58070

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Jordan LeitchLead Sponsor

Frequently Asked Questions

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

How many individuals have been recruited for this experiment?

"Affirmative, the information posted on clinicaltrials.gov illustrates that this research project is presently searching for participants. It was initially advertised on July 24th 2023 and last updated November 14th 2023; 50 volunteers are needed from 1 location."

Answered by AI

Are participants still able to join this trial?

"That is accurate. Per the information posted on clinicaltrials.gov, this medical trial was initially announced on July 24th 2023 and recently modified on November 14th 2023. At present, they are seeking to enroll 50 individuals from a single healthcare facility."

Answered by AI

What objectives are the researchers hoping to realize through this clinical trial?

"The main aim of the trial, which is estimated to last between 4 and 6 weeks before surgery, will be to assess retention rate. Secondary goals include recording re-admissions to hospital, presentations at emergency departments, and non-home discharges."

Answered by AI

Recent research and studies

Surgical EndoscopyJournal

Impact of a Trimodal Prehabilitation Program on Functional Recovery After Colorectal Cancer Surgery: A Pilot Study

Li, Chao, Francesco Carli, Lawrence Lee, Patrick Charlebois, Barry Stein, Alexander S. Liberman, Pepa Kaneva, et al.. 2012. “Impact of a Trimodal Prehabilitation Program on Functional Recovery After Colorectal Cancer Surgery: A Pilot Study”. Surgical Endoscopy. Springer Science and Business Media LLC. doi:10.1007/s00464-012-2560-5.

clinicaltrials.govStudy

Trimodal Prehabilitation in Colorectal Cancer Patients

Jordan Leitch 2023. "Trimodal Prehabilitation in Colorectal Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05880992.