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

Sponsor
Children's Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04089358
Collaborator
National Cancer Institute (NCI) (NIH), Yale University (Other)
384
Enrollment
101
Locations
2
Arms
62.1
Anticipated Duration (Months)
3.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • 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:
  1. 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:

  1. 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.

  2. 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

Study Type:
Interventional
Anticipated 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 :
Oct 26, 2020
Anticipated Primary Completion Date :
Dec 30, 2025
Anticipated Study Completion Date :
Dec 30, 2025

Arms and Interventions

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

    Primary Outcome Measures

    1. Change in minutes of moderate-to-vigorous physical activity (MVPA) per day from Baseline Evaluation [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 [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) [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 [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) [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 [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) [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) [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 [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 [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 [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) [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) [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

    Criteria

    Ages Eligible for Study:
    15 Years to 20 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 USA Health Strada Patient Care Center Mobile Alabama United States 36604
    2 Banner Children's at Desert Mesa Arizona United States 85202
    3 Kaiser Permanente Downey Medical Center Downey California United States 90242
    4 City of Hope Comprehensive Cancer Center Duarte California United States 91010
    5 Miller Children's and Women's Hospital Long Beach Long Beach California United States 90806
    6 Mattel Children's Hospital UCLA Los Angeles California United States 90095
    7 Valley Children's Hospital Madera California United States 93636
    8 Kaiser Permanente-Oakland Oakland California United States 94611
    9 Children's Hospital of Orange County Orange California United States 92868
    10 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
    11 Santa Barbara Cottage Hospital Santa Barbara California United States 93102
    12 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center Torrance California United States 90502
    13 Connecticut Children's Medical Center Hartford Connecticut United States 06106
    14 Yale University New Haven Connecticut United States 06520
    15 Alfred I duPont Hospital for Children Wilmington Delaware United States 19803
    16 MedStar Georgetown University Hospital Washington District of Columbia United States 20007
    17 Children's National Medical Center Washington District of Columbia United States 20010
    18 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    19 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
    20 Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida United States 33021
    21 Nemours Children's Clinic-Jacksonville Jacksonville Florida United States 32207
    22 Palms West Radiation Therapy Loxahatchee Groves Florida United States 33470
    23 AdventHealth Orlando Orlando Florida United States 32803
    24 Arnold Palmer Hospital for Children Orlando Florida United States 32806
    25 Nemours Children's Hospital Orlando Florida United States 32827
    26 Tampa General Hospital Tampa Florida United States 33606
    27 Augusta University Medical Center Augusta Georgia United States 30912
    28 Memorial Health University Medical Center Savannah Georgia United States 31404
    29 Saint Luke's Cancer Institute - Boise Boise Idaho United States 83712
    30 University of Illinois Chicago Illinois United States 60612
    31 Saint Jude Midwest Affiliate Peoria Illinois United States 61637
    32 Southern Illinois University School of Medicine Springfield Illinois United States 62702
    33 Riley Hospital for Children Indianapolis Indiana United States 46202
    34 Saint Vincent Hospital and Health Care Center Indianapolis Indiana United States 46260
    35 Blank Children's Hospital Des Moines Iowa United States 50309
    36 Norton Children's Hospital Louisville Kentucky United States 40202
    37 Children's Hospital New Orleans New Orleans Louisiana United States 70118
    38 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
    39 Eastern Maine Medical Center Bangor Maine United States 04401
    40 Maine Children's Cancer Program Scarborough Maine United States 04074
    41 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    42 Walter Reed National Military Medical Center Bethesda Maryland United States 20889-5600
    43 Massachusetts General Hospital Cancer Center Boston Massachusetts United States 02114
    44 Michigan State University Clinical Center East Lansing Michigan United States 48824-7016
    45 Helen DeVos Children's Hospital at Spectrum Health Grand Rapids Michigan United States 49503
    46 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
    47 Beaumont Children's Hospital-Royal Oak Royal Oak Michigan United States 48073
    48 Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis Minnesota United States 55404
    49 University of Minnesota/Masonic Cancer Center Minneapolis Minnesota United States 55455
    50 Mayo Clinic in Rochester Rochester Minnesota United States 55905
    51 University of Mississippi Medical Center Jackson Mississippi United States 39216
    52 Children's Mercy Hospitals and Clinics Kansas City Missouri United States 64108
    53 Washington University School of Medicine Saint Louis Missouri United States 63110
    54 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
    55 Children's Hospital and Medical Center of Omaha Omaha Nebraska United States 68114
    56 University of Nebraska Medical Center Omaha Nebraska United States 68198
    57 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    58 Hackensack University Medical Center Hackensack New Jersey United States 07601
    59 Morristown Medical Center Morristown New Jersey United States 07960
    60 Saint Peter's University Hospital New Brunswick New Jersey United States 08901
    61 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    62 Albany Medical Center Albany New York United States 12208
    63 Maimonides Medical Center Brooklyn New York United States 11219
    64 Roswell Park Cancer Institute Buffalo New York United States 14263
    65 NYU Winthrop Hospital Mineola New York United States 11501
    66 State University of New York Upstate Medical University Syracuse New York United States 13210
    67 Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina United States 28203
    68 Sanford Broadway Medical Center Fargo North Dakota United States 58122
    69 Children's Hospital Medical Center of Akron Akron Ohio United States 44308
    70 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo Ohio United States 43606
    71 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    72 Legacy Emanuel Children's Hospital Portland Oregon United States 97227
    73 Oregon Health and Science University Portland Oregon United States 97239
    74 Penn State Children's Hospital Hershey Pennsylvania United States 17033
    75 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    76 Saint Christopher's Hospital for Children Philadelphia Pennsylvania United States 19134
    77 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    78 Rhode Island Hospital Providence Rhode Island United States 02903
    79 BI-LO Charities Children's Cancer Center Greenville South Carolina United States 29605
    80 East Tennessee Childrens Hospital Knoxville Tennessee United States 37916
    81 Saint Jude Children's Research Hospital Memphis Tennessee United States 38105
    82 The Children's Hospital at TriStar Centennial Nashville Tennessee United States 37203
    83 Texas Tech University Health Sciences Center-Amarillo Amarillo Texas United States 79106
    84 Dell Children's Medical Center of Central Texas Austin Texas United States 78723
    85 Driscoll Children's Hospital Corpus Christi Texas United States 78411
    86 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
    87 El Paso Children's Hospital El Paso Texas United States 79905
    88 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston Texas United States 77030
    89 M D Anderson Cancer Center Houston Texas United States 77030
    90 Vannie Cook Children's Clinic McAllen Texas United States 78503
    91 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78229
    92 Children's Hospital of The King's Daughters Norfolk Virginia United States 23507
    93 Virginia Commonwealth University/Massey Cancer Center Richmond Virginia United States 23298
    94 Seattle Children's Hospital Seattle Washington United States 98105
    95 Providence Sacred Heart Medical Center and Children's Hospital Spokane Washington United States 99204
    96 Saint Vincent Hospital Cancer Center Green Bay Green Bay Wisconsin United States 54301
    97 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792
    98 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
    99 Children's Hospital of Wisconsin Milwaukee Wisconsin United States 53226
    100 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    101 IWK Health Centre Halifax Nova Scotia Canada B3K 6R8

    Sponsors and Collaborators

    • Children's Oncology Group
    • National Cancer Institute (NCI)
    • Yale University

    Investigators

    • Principal Investigator: Nina S Kadan-Lottick, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04089358
    Other Study ID Numbers:
    • ALTE2031
    • NCI-2020-01916
    • ALTE2031
    • COG-ALTE2031
    • ALTE2031
    • U01CA246665
    • UG1CA189955
    First Posted:
    Sep 13, 2019
    Last Update Posted:
    Aug 18, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Aug 18, 2022