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NCT05554159 | Recruiting | Brain Tumor


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

M.D. Anderson Cancer Center

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

Condition or disease

Brain Tumor

Brain Cancer

Intervention/treatment

Standard Fitbit Program

Virtual Exercise Program

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 40 participants
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
Actual Study Start Date : June 5, 2023
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024
Arm Intervention/treatment

Experimental: 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.

Behavioral: Standard Fitbit Program

Behavioral: Virtual Exercise Program

Ages Eligible for Study: 15 Years to 39 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
  • 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.
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
  • Prisoners
  • Self-reported pregnancy status

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

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

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Locations


Recruiting

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

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