Intervention for Children Undergoing Proton Radiation for Brain Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 22-004238
Sponsor Protocol Number: 22-004238
About this study
The purpose of this study is to develop and pilot a novel early intervention program for children undergoing proton radiation thereapy (PRT) for brain tumors.
Survivors of childhood brain cancers who undergo radiation therapy can have damage to normal brain tissue. Activities such as attention training and physical exercise can improve mental function in children with brain injury that is caused by the radiation therapy. Improvements in children’s ability to learn, behavior and fitness will lead to a better developmental outcome and quality of life in the longer term.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- The study participants will be recruited in the proton radiation therapy (PRT) facility of Mayo Clinic Rochester.
- Children between the age of 4 and 10 years with brain tumors annually.
- This age range is chosen as:
- Suitable for our intervention program;
- Appropriate for the chosen assessments;
- Compatible with ages associated with long-term neurocognitive deficits in prior studies.
Exclusion Criteria:
- Expected survival less than a year.
- Child or parent unable to speak or understand English.
- Child unable to participate in major components of the intervention due to severe limitations in visual/auditory abilities or mobility.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Yu Shi, M.D., M.P.H. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available