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

Phase 3

Active, not recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

• Registration Number: NCT04089358
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-9-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - First diagnosis of malignant neoplasm (International Classification of Diseases for<br> Oncology [ICD-O] behavior code of 3) in first and continuous remission at the time<br> of enrollment<br><br> - Curative cancer treatment must have included chemotherapy (including cellular<br> therapy) and/or radiation (including radioactive iodine)<br><br> - Note: Childrens Oncology Group (COG) therapeutic trial participation is not<br> required<br><br> - All cancer treatment must have been completed within 3-36 calendar months prior to<br> enrollment<br><br> - Patients must have a life expectancy of > 1 year<br><br> - Self-report of < 420 minutes of moderate-to-vigorous physical activity per week as<br> assessed via the study-specific Physical Activity Worksheet<br><br> - Note: See COG Study Web Page for the Godin-Shephard Leisure Time Physical<br> Activity Questionnaire or link to online calculator<br><br> - Ambulatory and no known medical contraindications to increasing physical activity<br><br> - Note: Patients with amputation, rotationplasty, or other prothesis are not<br> automatically excluded as long as they are ambulatory and have no known medical<br> contraindications to increasing physical activity and all other eligibility<br> criteria are satisfied<br><br> - No known significant physical or cognitive impairment that would prevent use of the<br> electronic devices used for the protocol intervention (e.g. Fitbit, smartphone,<br> tablet, or computer)<br><br> - Able to read and write English<br><br> - Note: For patients < 18 years, consenting parent/legal guardian does not have<br> to be able to read and write English<br><br> - All patients and/or their parents or legal guardians must sign a written informed<br> consent<br><br> - Note: Informed consent may be obtained electronically/online if allowed by<br> local site policy and Institutional Review Board (IRB)/Research Ethics Board<br> (REB) of record<br><br> - All institutional, Food and Drug Administration (FDA), and National Cancer Institute<br> (NCI) requirements for human studies must be met<br><br>Exclusion Criteria:<br><br> - Post-menarchal female patients who are pregnant or planning to become pregnant in<br> the next year are excluded<br><br> - Note: Pregnancy status can be established by clinical history with patient.<br> Post-menarchal female patients are eligible as long as they agree to use an<br> effective contraceptive method (including abstinence) during study<br> participation<br><br> - Patients with previous hematopoietic stem cell transplant (HSCT) are excluded<br><br> - Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell<br> (CAR T-cell) therapy, and other cellular cancer therapies can participate as<br> long as all other eligibility criteria are satisfied

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation

Secondary Outcome Measures

Name	Time	Method
Cardiopulmonary fitness;Body mass index (BMI);Resting heart rate;Health-related quality of life (HRQOL);Total cholesterol;High density lipoprotein (HDL);Low density lipoprotein (LDL);Triglycerides;Glucose;Insulin (HOMA-IR);Hemoglobin A1c (HbA1c);High sensitivity C-reactive protein (CRP)