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Behavioural Intervention
Virtual Exercise Program for Brain Cancer
N/A
Recruiting
Led By Maria Swartz, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion an average of 1 year.
Awards & highlights
Study Summary
This trial will test a new virtual exercise program for AYAs with brain tumors who are about to receive cranial radiotherapy.
Who is the study for?
This trial is for adolescents and young adults aged 15-39 with brain tumors who are about to undergo radiotherapy. They must be able to move, have internet access, a smartphone, and be willing to use a Fitbit. Participants should not be very active currently and cannot join if they're non-English speakers, pregnant, have unstable heart/lung conditions or injuries that prevent exercise.Check my eligibility
What is being tested?
The study is testing a new virtual exercise program against the standard Fitbit program in young people with brain tumors receiving radiotherapy. The goal is to see if the virtual exercises can help reduce cognitive deficits caused by the treatment.See study design
What are the potential side effects?
Since this trial involves an exercise program, potential side effects may include typical risks associated with physical activity such as muscle strain or injury. However, participants will receive physician clearance before starting.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 15 and 39 years old.
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I have been diagnosed with a brain tumor, either benign or malignant.
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I plan to receive CRT at MDACC.
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I can move my arms and legs and walk safely.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MD Anderson Symptom Inventory - Brain Tumor (MDASI - BT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ActigraphExperimental Treatment2 Interventions
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.
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,434 Total Patients Enrolled
Maria Swartz, MDPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently participating in another exercise program.I have a recent injury that stops me from joining exercise sessions.I do not speak English.I do not have unstable heart or lung conditions.I can move my arms and legs and walk safely.You are currently pregnant based on what you have reported.I, or my guardian, agree to participate in the Fitbit study and provide consent.You are not active enough and do less than 150 minutes of moderate to vigorous exercise per week.I have been diagnosed with a metastatic brain tumor.You are pregnant and have reported it yourself.You do not have any problems with moving or feeling that the clinical team has noticed.I plan to receive CRT at MDACC.I am eligible for physical therapy as part of my treatment plan.I am between 15 and 39 years old.I have been diagnosed with a brain tumor, either benign or malignant.
Research Study Groups:
This trial has the following groups:- Group 1: Actigraph
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To whom is participation in this clinical trial open?
"This trial is in search of 40 individuals between the ages 15 and 39 with a primary benign or malignant brain tumor. Qualifying participants must be able to walk and move their limbs, have access to informed consent, possess a smartphone capable of downloading apps, an internet connection, no sensorimotor strip impairments as reported by the clinical team, and report less than 150 minutes per week of planned moderate-vigorous activity."
Answered by AI
Is the inclusion criteria for this study limited to adults or are minors also eligible?
"As indicated in the trial's conditions for participation, those aged between 15 and 39 years old may enrol."
Answered by AI
Are there still available slots for enrolment in this experiment?
"The research posted on clinicaltrials.gov has concluded its recruitment phase, as the project was initially shared on February 28th 2023 and last edited September 26th 2022. Despite this, there are still 997 other studies actively searching for participants at present."
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