Brain Tumor Clinical Trial
Official title:
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
Verified date | June 2024 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
Status | Suspended |
Enrollment | 40 |
Est. completion date | February 28, 2027 |
Est. primary completion date | February 28, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 39 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) | Scale Score ranges from 0-10
0-Symptom has not been present 10-The symptom was as bad as you can imagine it could be |
Through study completion an average of 1 year. |
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