Web-Based Physical Activity Intervention in Improving Long Term Health in Children and Adolescents With Cancer

Phase 3

Active, not recruiting

• Conditions: Hematopoietic and Lymphatic System Neoplasm; Carcinoma In Situ; Malignant Solid Neoplasm

• Registration Number: NCT03223753
• Lead Sponsor: Children's Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-7-11
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

Inclusion Criteria:<br><br> - All cancer cases with an International Classification of Diseases for Oncology<br> (ICD)-O histologic behavior code of two 2 (carcinoma in situ) or three 3<br> (malignant), in remission<br><br> - Patient must have completed curative therapy (surgery and/or radiation and/or<br> chemotherapy) within the past 12 months at a Childrens Oncology Group (COG)<br> institution<br><br> - Patients must have a performance status corresponding to Eastern Cooperative<br> Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients =< 16 years of<br> age<br><br> - At the time of consent, patient or parent/guardian reports less than 420 minutes of<br> moderate to vigorous physical activity over the last week<br><br> - Patient and at least one parent/guardian are able to read and write English,<br> Spanish, and/or French; at least 1 parent/guardian must be able to read and write<br> English, Spanish, and/or French in order to assist the patient with using their<br> physical activity tracking device account<br><br> - All patients and/or their parents or legal guardians must sign a written informed<br> consent<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> - Patients with previous hematopoietic stem cell transplant (HSCT)<br><br> - Patients with significant concurrent disease, illness, psychiatric disorder or<br> social issue that would compromise patient safety or compliance with protocol<br> therapy, or interfere with consent, study participation, follow up, or<br> interpretation of study results<br><br> - Female patients who are pregnant are not eligible; women of childbearing potential<br> require a negative pregnancy test<br><br> - Female patient who is postmenarcheal and has not agreed to use an effective<br> contraceptive method (including abstinence) for the duration of study participation<br><br> - Patients with a cognitive, motor, visual or auditory impairment that prevents<br> computer use (e.g. unresolved posterior fossa syndrome) are not eligible

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physiologic cost index (PCI)

Secondary Outcome Measures

Name	Time	Method
Change in markers of cardiometabolic health;Change in inflammation;Change in quality of life;Change in fatigue;Change in school attendance;Markers of cardiometabolic health