Clinical trial NCT05554159: A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
Official title: A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Brain Tumor
Brain Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
timeFrame: Through study completion an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Maria L Schadler, MD
role: PRINCIPAL_INVESTIGATOR
References: