A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors

NCT05554159 | Terminated

• 2 other identifiers: 2022-0152NCI-2022-08000
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Tumor; Brain Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Actigraph

EXPERIMENTAL

A device worn on the waist that measures physical activity (such as the number of steps participants walk each day, how long participants spend standing, and how long partticipants spend laying down). Participants should wear the ActiGraph at least 10 hours a day for 7 days.

Behavioral: Standard Fitbit Program; Behavioral: Virtual Exercise Program

Interventions

Standard Fitbit Program BEHAVIORAL

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.

Actigraph

Virtual Exercise Program BEHAVIORAL

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.

Actigraph

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Maria L Schadler, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 26, 2022
• Study Start: June 5, 2023
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

US (1)