A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
- Conditions
- Brain TumorBrain Cancer
- Registration Number
- NCT05554159
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy
- Detailed Description
Primary Objective:
Determine the feasibility and acceptability of a virtually supervised exercise intervention compared to control in AYAs with brain tumors undergoing cranial radiotherapy (CRT).
Secondary Objective:
Assess the effect of supervised exercise intervention on the neuroanatomic structure and cognitive function changes in AYAs with brain tumors undergoing CRT.
Exploratory Objective:
Assess the effect of supervised exercise intervention on other brain structure (white matter integrity), cognitive functions (attention, visual learning, psychomotor function, executive function, verbal learning, working memory and clinician-reported neurological exam outcomes), patient-reported health-related quality of life, objectively measured and patient-reported physical activity level, patient-reported dietary recall, objectively measured physical function assessments, and exercise progression (exercise volume). Assess the agreement between physical function tests performed twice virtually.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- Age 15-39 years old
- 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)
- 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
- Received appropriate physician clearance
- Able to move arms and legs, and ambulate safely
- Participant is insufficiently active (reports less than 150 minutes of planned moderate-vigorous intensity activity per week in the prior week)
- Participants and/or guardians are willing and able to provide informed consent
- Has a smartphone with available space to download additional apps
- Does not have sensorimotor strip impairment as indicated by the clinical team
- Has internet access
- Can receive physical therapy because this is part of the standard of care
- 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.
- Non-English speaking
- Screen failure for exercise safety based on Physical Activity Readiness Questionnaire (PAR-Q).12
- Underlying unstable cardiac or pulmonary disease or symptomatic cardiac disease
- Recent fracture or acute musculoskeletal injury that precludes ability to participate in supervised exercise training sessions
- Cognitive and/or major sensory deficits that would impede the completion of research activities and assessments as deemed by the clinical team.
- Self-reported diagnosis of a metastatic brain tumor or confirmed diagnosis of a metastatic brain tumor radiographically or pathologically when available
- Self-report of pregnancy
- Currently enrolled in another physical activity or exercise intervention
- Prisoners
- Self-reported pregnancy status
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT) Through study completion an average of 1 year. 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
M D Anderson Cancer Center🇺🇸Houston, Texas, United StatesKeri L Schadler, MDPrincipal Investigator