RECRUITING

Improving Exercise Capacity With a Tailored Physical Activity Intervention

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 research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life. Participants will be randomized to 1 of 2 pathways: * First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment. * Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.

Official Title

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment

Quick Facts

Study Start:2023-03-01
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05595577

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 to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals aged 18- 85 years
  2. * Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer
  3. * Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzumab, rituximab\]), immuno-therapies (immune checkpoint inhibitors \[ICI's\]) or radiation (within 8 weeks of completion of radiation).29-31
  4. * Ability to speak and understand English
  5. * Capacity to walk at least 2 city blocks (\~.2 miles) on a flat surface
  6. * Expected survival beyond 6 months.
  7. * Must have an assistant that will help perform the home-based testing activities
  1. * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
  2. * Recent history of alcohol or drug abuse, inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.
  3. * Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)
  4. * Pregnant
  5. * Unstable angina
  6. * Contraindication for exercise training or testing
  7. * Inability to exercise on a treadmill or stationary cycle
  8. * Significant ventricular arrhythmias (\>20 PVCs/min due to gating difficulty)
  9. * Atrial fibrillation with uncontrolled ventricular response
  10. * Acute myocardial infarction within 28 days
  11. * Inability to provide informed consent

Contacts and Locations

Study Contact

Study Coordinator
CONTACT
336-758-3728
scnorton@wakehealth.edu

Principal Investigator

William Hundley, MD
PRINCIPAL_INVESTIGATOR
Wake Forest Baptist Comprehensive Cancer Center

Study Locations (Sites)

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • William Hundley, MD, PRINCIPAL_INVESTIGATOR, Wake Forest Baptist Comprehensive Cancer Center

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 Date2023-03-01
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-03-01
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Exercise capability
  • Brain activity

Additional Relevant MeSH Terms

  • Non Hodgkin Lymphoma
  • Heart; Functional Disturbance
  • Hodgkin Lymphoma
  • Quality of Life
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Stage III Breast Cancer