RECRUITING

The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to determine the feasibility of a prehabilitation program for participants diagnosed with rectal cancer undergoing neoadjuvant chemotherapy and/or radiation, followed by surgical resection. The names of the groups in this research study are: * Group A: Prehabilitation program * Group B: Usual Care

Official Title

The Impact of PReOPerative Exercise and NutritionaL Optimization on Perioperative Outcomes for Patients Undergoing Treatment for Rectal Cancer: the PROPEL Trial

Quick Facts

Study Start:2024-12-15
Study Completion:2027-08-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06565052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age greater than or equal to 18 years at time of enrollment.
  2. * English-Speaking.
  3. * Diagnosis of clinical stage II-III rectal cancer.
  4. * Planned, ongoing or just completed neoadjuvant treatment, including either 1) chemoradiation, 2) total neoadjuvant therapy (TNT), or 3) chemotherapy only; and anticipated surgical resection to follow.
  5. * Able to understand the study procedures, agree to participate in the study program, and voluntarily provide informed consent.
  1. * Distant metastatic disease known at the time of diagnosis.
  2. * Functional incapacity (i.e., incapable of performing exercise testing).
  3. * Comorbid conditions or cognitive/physical impairments that contraindicate exercise.
  4. * Currently undergoing treatment for a secondary primary tumor, in addition to primary rectal cancer.
  5. * Currently enrolled in a separate clinical trial that would prohibit them from performing the tasks instructed in this trial.
  6. * Currently participating in more than 60 minutes of moderate-to-vigorous aerobic exercise per week over the past month. This study targets insufficiently active persons to assess the effect of the described intervention, where additional exercise done regularly will contaminate the intervention effects.

Contacts and Locations

Study Contact

Jeffrey Meyerhardt, MD, MPH
CONTACT
617-632-6855
jeffrey_meyerhardt@dfci.harvard.edu

Principal Investigator

Jeffrey Meyerhardt, MD, MPH
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

  • Jeffrey Meyerhardt, MD, MPH, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-15
Study Completion Date2027-08-07

Study Record Updates

Study Start Date2024-12-15
Study Completion Date2027-08-07

Terms related to this study

Keywords Provided by Researchers

  • Rectal Cancer
  • Colorectal Cancer
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III

Additional Relevant MeSH Terms

  • Rectal Cancer
  • Colorectal Cancer
  • Rectal Cancer Stage II
  • Rectal Cancer Stage III