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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05554159
Other study ID # 2022-0152
Secondary ID NCI-2022-08000
Status Suspended
Phase N/A
First received
Last updated
Start date June 5, 2023
Est. completion date February 28, 2027

Study information

Verified date June 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy


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 information / eligibility

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

Study Design


Intervention

Behavioral:
Standard Fitbit Program
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.
Virtual Exercise Program
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.

Locations

Country Name City State
United States M D Anderson Cancer Center Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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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