Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer
Trial ID or NCT#
NCT03223753,
Status
RECRUITING
Purpose
This randomized clinical phase III trial studies how well web-based physical activity intervention works in improving long term health in children and adolescents with cancer. Regular physical activity after receiving treatment for cancer may help to maintain a healthy weight and improve energy levels and overall health.
Official Title
A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer
Eligibility Criteria
Ages Eligible for Study: 8 Years to 16 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - All cancer cases with an International Classification of Diseases for Oncology (ICD)-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission - Patient must have completed curative therapy (surgery and/or radiation and/or chemotherapy) within the past 12 months at a Childrens Oncology Group (COG) institution - Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of age - 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 and at least one parent/guardian are able to read and write English, Spanish, and/or French; at least 1 parent/guardian must be able to read and write English, Spanish, and/or French in order to assist the patient with using their physical activity tracking device account - All patients and/or their parents or legal guardians must sign a written informed consent - All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
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 and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation - Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g. unresolved posterior fossa syndrome) are not eligible
Investigator(s)
Jay Michael S. Balagtas
Sheri Spunt
Contact us to find out if this trial is right for you.
Contact
Christopher Nguyen Le
650-725-4318
View on ClinicalTrials.gov
