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

Primary Purpose

Brain Tumor, Brain Cancer

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard Fitbit Program

Virtual Exercise Program

About this trial

This is an interventional supportive care trial for Brain Tumor

Eligibility Criteria

15 Years - 39 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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
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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Actigraph

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05554159

First Posted

September 21, 2022

Last Updated

June 13, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05554159

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 5, 2023 (Actual)

Primary Completion Date

February 29, 2024 (Anticipated)

Study Completion Date

February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Tumor, Brain Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Actigraph

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Standard Fitbit Program

Intervention Description

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

Intervention Name(s)

Virtual Exercise Program

Intervention Description

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Through study completion an average of 1 year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

39 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maria Swartz, MD

Phone

713-745-3763

mchang1@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria Swartz, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Swartz, MD

Phone

713-745-3763

mchang1@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Maria Swartz, MD

12. IPD Sharing Statement

Links:

URL

http://mdanderson.org

Description

M D Anderson Cancer Center

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

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