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

NCT ID: NCT05554159

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2025-07-28

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.

Conditions

Brain Tumor; Brain Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Actigraph

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.

Group Type: EXPERIMENTAL

Standard Fitbit Program

Intervention Type: 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.

Virtual Exercise Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria L Schadler, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2022-08000

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0152

Identifier Type: -

Identifier Source: org_study_id