TERMINATED

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-06-05

Study Completion:2025-07-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05554159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years to 39 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Principal Investigator

Maria L Schadler, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Maria L Schadler, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-05

Study Completion Date2025-07-28

Study Record Updates

Study Start Date2023-06-05

Study Completion Date2025-07-28

Terms related to this study

Additional Relevant MeSH Terms

Brain Tumor
Brain Cancer