We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04089358
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : May 23, 2023
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Yale University
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hematopoietic and Lymphoid Cell Neoplasm Malignant Solid Neoplasm Other: Educational Intervention Device: FitBit Other: Goal Setting Other: Health Promotion and Education Other: Media Intervention Behavioral: Telephone-Based Intervention Phase 3

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: StepByStep: A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among Adolescent and Young Adult Childhood Cancer Survivors
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control Group (educational materials, Fitbit)
Participants receive educational materials about physical activity and wear a Fitbit daily for 48 weeks.
 Other: Educational Intervention
Receive educational materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Device: FitBit
Wear a Fitbit
Experimental: Intervention group (educational materials, goal set, Fitbit)
See outline
 Other: Educational Intervention
Receive educational materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

Device: FitBit
Wear a Fitbit

Other: Goal Setting
Set goals

Other: Health Promotion and Education
Receive text message about goal setting

Other: Media Intervention
Follow Instagram group

Behavioral: Telephone-Based Intervention
Receive phone call about goal setting


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Cardiopulmonary fitness [ Time Frame: 12 months ]
    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.

  2. Body mass index (BMI) [ Time Frame: 12 months ]
    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.

  3. Resting heart rate [ Time Frame: 12 months ]
    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.

  4. Health-related quality of life (HRQOL) [ Time Frame: 12 months ]
    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.

  5. Total cholesterol [ Time Frame: 12 months ]
    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.

  6. High density lipoprotein (HDL) [ Time Frame: 12 months ]
    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).

  7. Low density lipoprotein (LDL) [ Time Frame: 12 months ]
    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).

  8. Triglycerides [ Time Frame: 12 months ]
    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.

  9. Glucose [ Time Frame: 12 months ]
    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.

  10. Insulin [ Time Frame: 12 months ]
    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.

  11. Hemoglobin A1c (HbA1c) [ Time Frame: 12 months ]
    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. High sensitivity C-reactive protein (CRP) [ Time Frame: 12 months ]
    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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089358


Locations
Show Show 115 study locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Yale University
Investigators
Layout table for investigator information
Principal Investigator: Nina S Kadan-Lottick Children's Oncology Group
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT04089358    
Other Study ID Numbers: ALTE2031
NCI-2020-01916 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ALTE2031 ( Other Identifier: Children's Oncology Group )
COG-ALTE2031 ( Other Identifier: DCP )
ALTE2031 ( Other Identifier: CTEP )
U01CA246665 ( U.S. NIH Grant/Contract )
UG1CA189955 ( U.S. NIH Grant/Contract )
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: April 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms