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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Educational Intervention
* Device: FitBit
* Other: Goal Setting
* Other: Health Promotion and Education
* Other: Media Intervention
* Behavioral: Telephone-Based Intervention


Participation Criteria
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Eligibility Criteria
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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 (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 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 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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (educational materials, Fitbit)<br>Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks. | Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Device: FitBit<br>* Wear a Fitbit<br>|
| Experimental: Intervention group (educational materials, goal set, Fitbit)<br>See outline | Other: Educational Intervention<br>* Receive educational materials<br>* Other names: Intervention, Educational;Device: FitBit<br>* Wear a Fitbit<br>Other: Goal Setting<br>* Set goals<br>Other: Health Promotion and Education<br>* Receive text message about goal setting<br>Other: Media Intervention<br>* Follow Instagram group<br>Behavioral: Telephone-Based Intervention<br>* Receive phone call about goal setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation | Moderate-to-vigorous physical activity (MVPA) will be tracked using a wearable activity monitor (research-grade accelerometer) that counts how often (how many times) someone performs MVPA over a 7 day period. Total minutes above the moderate-intensity threshold will be divided by the number of valid days to obtain minutes of MVPA per day. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary fitness | Cardiopulmonary fitness is an objective biomarker of exercise capacity and will be assessed by the 2-Minute Step Test. During the 2-Minute Step Test, participants are asked to march in place as quickly as possible for 2 minutes. This test requires a stopwatch and a counter. Stopping, starting, and resting during the test are allowed as needed. Steps are counted. | 12 months | 
| Body mass index (BMI) | Participants will be measured for height and weight without shoes and wearing light clothes using a stadiometer or measuring tape and scale, respectively. BMI will be calculated as weight (kg) divided by height squared (m2). BMI will be examined as a potential covariate for the analysis of fitness as measured by the 2-Minute Step Test. | 12 months | 
| Resting heart rate | Resting heart rate will be taken using the Fitbit physical activity tracker heart rate monitor after the patient has been sitting upright with both feet on the floor for five minutes. | 12 months | 
| Health-related quality of life (HRQOL) | HRQOL will be measured with the Pediatric Quality of Life inventory (PedsQL) 4.0 Generic Core Scales (global functioning, physical functioning, and social functioning scales, specifically) and the 18-item PedsQL 4.0 Multidimensional Fatigue Scale, which encompasses three subscales: (1) general fatigue (6 items), (2) sleep/rest fatigue (6 items), and (3) cognitive fatigue (6 items).115-118 Questions refer to how much of a problem each item was during the past month. Items are reverse-scored and transformed to a scale from 0-100, in which higher scores indicate better HRQOL. | 12 months | 
| Total cholesterol | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: total cholesterol. | 12 months | 
| High density lipoprotein (HDL) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: high density lipoprotein (HDL). | 12 months | 
| Low density lipoprotein (LDL) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: low density lipoprotein (LDL). | 12 months | 
| Triglycerides | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: triglycerides. | 12 months | 
| Glucose | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: glucose. | 12 months | 
| Insulin | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: insulin. | 12 months | 
| Hemoglobin A1c (HbA1c) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: hemoglobin A1c (HbA1c). | 12 months | 
| High sensitivity C-reactive protein (CRP) | A dried blood sample will be collected on each participant after a minimum of an 8-hour fast. A total of 3 drops of blood will be collected by finger stick with a lancet. Samples will be tested for: high sensitivity C-reactive protein (CRP). | 12 months |