A Randomized Web-based Physical Activity Intervention among Children and Adolescents with Acute Lymphoblastic Leukemia
S
Sandeep Batra, MD
Primary Investigator
Enrolling By Invitation
8-15 years
All
Phase
N/A
2 participants needed
3 Locations
Overview
What is the purpose of this study?
This randomized clinical trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with newly diagnosed acute lymphoblastic leukemia that shows a decrease in or disappearance of signs and symptoms. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
- Patients are randomized to 1 of 2 arms.
- ARM I: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the limited version of the app/website to get basic information related to their physical activity. Patients will not be told of the details of earning of monetary incentives. Their activity will be monitored during the 6 month intervention period and will receive all earned gift cards or prizes after the intervention period ends. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives.
- ARM II: Patients receive educational handouts about physical activity and are encouraged to increase physical activity to at least 420 minutes per week. Patients wear a physical activity tracking device daily and upload data at least once a week to the device app/website. Patients also access the full version of the interactive-reward based device app/website to see their activity, earn activity points, see other's activity, and interact with other patients randomized to this study arm. Patients will receive additional details about how to earn gift cards or prizes for engaging in the intervention and will be rewarded for all earned incentives throughout the 6 month intervention period. The patient will be encouraged to continue to wear the device for the remainder of the study, although they will no longer be earning monetary incentives.
- After completion of study, patients are followed up at 24 and 48 weeks.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Riley, Carcinoma In Sit,u Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
-
Age: Between 8 Years - 15 Years
-
Gender: All
Inclusion Criteria
- Patient must be a newly diagnosed ALL, in first remission
- Patient must have completed curative chemotherapy within past 6 months at a Childrens Oncology Group (COG) institution
- At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week
- Patient must have access to a smart phone with Android 4.3 or later or iOS 7.1 or later or computer (laptop/desktop) with a connection to the internet to create an account and be able to sync the Sqord device (accelerometer)
- Patient and at least one parent/guardian are able to read and write English; at least 1 parent/guardian must be able to read and write English in order to assist the patient with using their Sqord account
Exclusion Criteria
- Patients with previous hematopoietic stem cell transplant (HSCT)
- Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results
- Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test
- Female patient who is postmenarcheal has agreed to use an effective contraceptive method (including abstinence) for the duration of study participation
Updated on
12 Sep 2024.
Study ID: 1802415208, PHO-PRADHAN-COG-ALTE1631
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