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Clinical Trials/NCT05554159
NCT05554159
Terminated
Not Applicable

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

M.D. Anderson Cancer Center1 site in 1 country10 target enrollmentJune 5, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumor
Sponsor
M.D. Anderson Cancer Center
Enrollment
10
Locations
1
Primary Endpoint
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
Status
Terminated
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 5, 2023
End Date
July 28, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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
  • Self-reported pregnancy status

Outcomes

Primary Outcomes

MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)

Time Frame: Through study completion an average of 1 year.

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

Study Sites (1)

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