RECRUITING

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

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Conditions

Colonic Neoplasms

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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

To goal of this clinical trial is to quantify the dose-response effects of aerobic exercise training compared to attention control on chemotherapy relative dose intensity in colon cancer survivors.

Official Title

Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer

Quick Facts

Study Start:2023-06-01
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05773144

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 ≥18 years
  2. * Histologically confirmed stage II or III colon cancer
  3. * Completed surgical resection with curative intent
  4. * Plan to initiate chemotherapy
  5. * Engage in \<60 minutes per week of moderate- to vigorous-intensity structured aerobic exercise
  6. * No planned major surgery during the study period
  7. * Readiness to exercise, as determined by a modified version of the Physical Activity Readiness Questionnaire
  8. * Can walk 400 meters
  9. * Can read and speak English
  10. * Ability to provide written informed consent
  11. * Provide written approval by qualified healthcare professional
  12. * Willing to be randomized
  1. * Evidence of metastatic colon cancer
  2. * Concurrently actively treated other (non-colon) cancer
  3. * Currently pregnant, breastfeeding, or planning to become pregnant within the next 24 weeks
  4. * Currently participating in another study with competing outcomes
  5. * Any other condition that, in the opinion of the investigator, would preclude participation or successful compliance with the protocol
  6. * Any other situation that, in the opinion of the investigator, would negatively impact subject safety or successful compliance with the protocol

Contacts and Locations

Study Contact

Justin C. Brown, Ph.D.
CONTACT
225-763-2715
justin.brown@pbrc.edu

Principal Investigator

Justin C. Brown, Ph.D.
PRINCIPAL_INVESTIGATOR
Pennington Biomedical Research Center
Jeffrey A. Meyerhardt, M.D., M.P.H.
PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Bette J. Caan, Dr.P.H.
PRINCIPAL_INVESTIGATOR
Kaiser Permanente

Study Locations (Sites)

Kaiser Permanente Northern California
Oakland, California, 94612
United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Pennington Biomedical Research Center

  • Justin C. Brown, Ph.D., PRINCIPAL_INVESTIGATOR, Pennington Biomedical Research Center
  • Jeffrey A. Meyerhardt, M.D., M.P.H., PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute
  • Bette J. Caan, Dr.P.H., PRINCIPAL_INVESTIGATOR, Kaiser Permanente

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 Date2023-06-01
Study Completion Date2027-05

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2027-05

Terms related to this study

Additional Relevant MeSH Terms

  • Colonic Neoplasms