A Study to Evaluate Web-Based Physical Activity Intervention in Children and Adolescents with Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission

Overview

About this study

The primary purpose of this study is to compare the effects of a rewards-and web-based physical activity intervention that includes structured social interaction between participants to the same web-based physical activity intervention that does not include structured social interaction on fitness among children and adolescents following treatment for cancer.

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:

  • Patient must be ≥ 8 years of age and ≤ 16 years of age at time of enrollment.
  • All cancer cases with an ICD-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission.
  • Patient must have completed curative chemotherapy within 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 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.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, FDA, and 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.

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

Carola Arndt, M.D.

Open for enrollment

Contact information:

Rebecca Winslow Rain

(507) 284-2657

WinslowRain.Rebecca@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20506108

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