Summary

Eligibility
for people ages 15-20 (full criteria)
Location
at UC Davis UCLA
Dates
study started
estimated completion
Principal Investigator
by Jacqueline N. Casillas (ucla)Marcio H. Malogolowkin (ucdavis)Eduard H. Panosyan (ucla)

Description

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.

Official Title

StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors

Details

PRIMARY OBJECTIVE: I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on physical activity among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. SECONDARY OBJECTIVES: I. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on biomarkers predictive of cardiometabolic health among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. II. To evaluate the effects of a multi-component physical activity intervention including a Fitbit, individualized goal setting, and a social media peer support group compared to the control condition (Fitbit only) on health-related quality of life among adolescent and young adult survivors of childhood cancer (AYA survivors) who do not meet physical activity guidelines. OUTLINE: Participants are randomized to 1 of 2 groups. INTERVENTION GROUP: Participants receive educational materials about physical activity. INTENSIVE PHASE (24 WEEKS): Participants wear a physical activity tracker (Fitbit) daily as well as receiving weekly reminders from study staff to wear it. They also receive goal setting sessions each week (by text, phone call, etc.) to set personalized step count goals using the Fitbit application (app). Lastly, participants receive an invitation to follow and post on an online social media peer support group (Instagram), where study staff provide encouraging advice and messages about physical activity 2-3 times per week, announce badges/awards every week, and moderate a forum to discuss physical activity and use of the Fitbit. MAINTENANCE PHASE (24 WEEKS): Participants wear a Fitbit daily but do not receive reminders to wear it. They also set their own step count goals weekly and check in with study staff monthly for assistance with goal setting. Participants take the lead posting content on the Instagram account moderated by the study staff. Study staff only post once per week with general physical activity-related questions and provide no badges. CONTROL GROUP: Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.

Keywords

Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Neoplasms Educational Intervention FitBit Goal Setting Health Promotion and Education Media Intervention Telephone-Based Intervention

Eligibility

You can join if…

Open to people ages 15-20

  • 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 (including cellular therapy) and/or radiation (including radioactive iodine)
  • 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
  • Note: Patients with amputation, rotationplasty, or other prothesis are not automatically excluded as long as they are ambulatory and have no known medical contraindications to increasing physical activity and all other eligibility criteria are satisfied
  • 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
  • Note: For patients < 18 years, consenting parent/legal guardian does not have to be 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

You CAN'T join if...

  • 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
  • Note: Patients with previous autologous HSCT, chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate as long as all other eligibility criteria are satisfied

Locations

  • Mattel Children's Hospital UCLA accepting new patients
    Los Angeles California 90095 United States
  • University of California Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States
  • Kaiser Permanente-Oakland accepting new patients
    Oakland California 94611 United States
  • Valley Children's Hospital accepting new patients
    Madera California 93636 United States
  • Kaiser Permanente Downey Medical Center accepting new patients
    Downey California 90242 United States
  • Miller Children's and Women's Hospital Long Beach accepting new patients
    Long Beach California 90806 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Lead Scientists at UC Cancer

  • Jacqueline N. Casillas (ucla)
    HS Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 49 research publications
  • Marcio H. Malogolowkin (ucdavis)
    Professor, Pediatrics. Authored (or co-authored) 102 research publications
  • Eduard H. Panosyan (ucla)
    HS Associate Clinical Professor, Pediatrics, Medicine. Authored (or co-authored) 25 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Children's Oncology Group
ID
NCT04089358
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 384 study participants
Last Updated