Virtual exercise program for young adults with brain tumors undergoing radiotherapy
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
This study is testing a new virtual exercise program for young adults with brain tumors who are getting radiotherapy to see if it helps them feel better and improves their overall health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 15 Years to 39 Years |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05554159 on ClinicalTrials.gov |
What this trial studies
This study tests a new virtual exercise program designed for adolescents and young adults (AYAs) with brain tumors who are about to undergo cranial radiotherapy. The primary goal is to evaluate the feasibility and acceptability of this exercise intervention compared to a control group. Additionally, the study aims to assess the impact of the exercise on cognitive function and neuroanatomic changes, as well as various health-related quality of life measures. Participants will engage in a supervised exercise regimen delivered virtually, utilizing technology such as Fitbits to monitor activity levels.
Who should consider this trial
Good fit: Ideal candidates are adolescents and young adults aged 15-39 with a diagnosis of a primary brain tumor who are planning to receive cranial radiotherapy.
Not a fit: Patients who are highly active or have significant sensorimotor impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could improve cognitive function and overall quality of life for young patients undergoing treatment for brain tumors.
How similar studies have performed: Previous studies have shown promise in using exercise interventions to support cognitive function in cancer patients, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 15-39 years old 2. Self-reported diagnosis of a primary benign or malignant brain tumor or confirmed diagnosis of primary benign or malignant brain tumor radiographically or pathologically when available (relapse or newly diagnosed) 3. Plans to receive CRT at MDACC or, if the participant has already started CRT, the participant is eligible if they are within 3 weeks of the start of CRT 4. Received appropriate physician clearance 5. Able to move arms and legs, and ambulate safely 6. Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week) 7. Participants and/or guardians are willing and able to provide informed consent 8. Has a smartphone with available space to download additional apps 9. Does not have sensorimotor strip impairment as indicated by the clinical team 10. Has internet access 11. Can receive physical therapy because this is part of the standard of care 12. Participants and/or guardians are willing and able to provide informed consent for protocol PA18-0130 (Pediatric Energy Balance Data Repository Study), companion protocol for the Fitbit application/assessment. Exclusion Criteria: 1. Non-English speaking 2. Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12 3. Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease 4. Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions 5. Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team. 6. Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available 7. Self-report of pregnancy 8. Currently enrolled in another physical activity or exercise intervention 9. Prisoners 10. Self-reported pregnancy status
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Maria L Schadler, MD — M.D. Anderson Cancer Center
- Study coordinator: Keri L Schadler, MD
- Email: klschadl@mdanderson.org
- Phone: 713-794-1035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.