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Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors, the StepByStep Study

About

Brief Summary

This phase III trial compares a multi-component mobile health and social media physical activity intervention versus wearing a physical activity tracker alone among adolescent and young adult childhood cancer survivors. Regular physical activity helps maintain healthy weight, energy levels, and health. Adolescents and young adults who complete treatment for cancer are often less active. They may gain weight and have more health problems compared to people the same age who have not had treatment for cancer. Comparing the 2 programs will help researchers learn how to increase physical activity levels over time and also how changes in physical activity levels affect health and quality of life over time.

Primary Purpose
Prevention
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
15 Years
Maximum Age
20 Years

Inclusion Criteria:

  • First diagnosis of malignant neoplasm (International Classification of Diseases for Oncology [ICD-O] behavior code of "3") in first and continuous remission at the time of enrollment
  • Curative cancer treatment must have included chemotherapy and/or radiation
    • Note: Childrens Oncology Group (COG) therapeutic trial participation is not required
  • All cancer treatment must have been completed within 3-36 calendar months prior to enrollment
  • Patients must have a life expectancy of > 1 year
  • Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as assessed via the study-specific Physical Activity Worksheet
    • Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical Activity Questionnaire or link to online calculator
  • Ambulatory and no known medical contraindications to increasing physical activity
  • No known significant physical or cognitive impairment that would prevent use of the electronic devices used for the protocol intervention (e.g. Fitbit, smartphone, tablet, or computer)
  • Able to read and write English
  • All patients and/or their parents or legal guardians must sign a written informed consent
    • Note: Informed consent may be obtained electronically/online if allowed by local site policy and Institutional Review Board (IRB)/Research Ethics Board (REB) of record
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Post-menarchal female patients who are pregnant or planning to become pregnant in the next year are excluded
    • Note: Pregnancy status can be established by clinical history with patient. Post-menarchal female patients are eligible as long as they agree to use an effective contraceptive method (including abstinence) during study participation
  • Patients with previous hematopoietic stem cell transplant (HSCT) are excluded

Join this Trial

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Study Stats
Protocol No.
21-001561
Category
Oncology
Pediatrics
Contact
Mikayla Marvis Henderson
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT04089358
For detailed technical eligibility, visit ClinicalTrials.gov.