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Trial Title:
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
NCT ID:
NCT05554159
Condition:
Brain Tumor
Brain Cancer
Conditions: Official terms:
Brain Neoplasms
Cognition Disorders
Cognitive Dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Suspended
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Standard Fitbit Program
Description:
Participants will be given a Fitbit to wear during their participation in this program.
Participants will need to wear the Fitbit at least 5 days per week and for at least 10
hours a day. Participants will take part in video calls (through the video conferencing
platform Zoom) 1 time a week.
Arm group label:
Actigraph
Intervention type:
Behavioral
Intervention name:
Virtual Exercise Program
Description:
Participants will be given a Fitbit to wear during their participation in this program.
Participants will need to wear the Fitbit at least 5 days per week and for at least 10
hours a day. Participants will take part in video calls (through the video conferencing
platform Zoom) 1 time a week.
Arm group label:
Actigraph
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.
Criteria for 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
Gender:
All
Minimum age:
15 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
June 5, 2023
Completion date:
February 28, 2027
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05554159
http://mdanderson.org
