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TLCFIT: Mobile Health Fitness Program for Adolescent and Young Adult Childhood Cancer Survivors

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Completed
CT.gov ID
NCT02688192
Collaborator
National Cancer Institute (NCI) (NIH), Rutgers Cancer Institute of New Jersey (Other)
49
Enrollment
2
Locations
2
Arms
54.9
Actual Duration (Months)
24.5
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies a mobile health fitness program for adolescent and young adult childhood cancer survivors. Adolescent and young adult childhood cancer survivors are at risk to have negative late effects from treatment and to develop chronic health conditions. A sedentary lifestyle may increase the risk of cardiovascular disease, osteoporosis, and early mortality. Physical activity reduces the risk for cardiovascular disease and early mortality, improves cardiorespiratory fitness, muscular fitness, bone health, and body composition, and it is also positively associated with quality of life. Programs and technologies that promote physical activity are important because health behaviors adopted by adolescent and young adult childhood cancer survivors are likely to continue into adulthood. A mobile health fitness application may motivate adolescent and young adult childhood cancer survivors to engage and maintain physical activity.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Exercise Intervention
  • Behavioral: Internet-Based Intervention
  • Device: Monitoring Device
  • Other: Quality-of-Life Assessment
 N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.
SECONDARY OBJECTIVES:

  1. Determine the effectiveness of the technology-enhanced fitness program on participants' cardiorespiratory fitness and muscular fitness.

  2. Examine the effects of the program on secondary outcomes of health related quality of life (HRQOL) and fatigue.

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I (Intervention): Participants attend 8 group meetings weekly, wear an electronic accelerometer, engage in private social support messaging within the app and Facebook private groups, and then use the mobile app for 4 weeks without in-person groups.

ARM II (WAITLIST CONTROL [WLC]): After the 6 month assessment, participants receive the FitSurvivor intervention as in arm I.

Study Design

Study Type:
Interventional
Actual Enrollment :
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
Actual Study Start Date :
Jan 2, 2014
Actual Primary Completion Date :
May 22, 2018
Actual Study Completion Date :
Jul 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Arm I (Intervention)

Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app

Behavioral: Exercise Intervention
Participate in fitness program

Behavioral: Internet-Based Intervention
Engage in private social support messaging and Use the mobile app

Device: Monitoring Device
Wear an electronic accelerometer
Other Names:
  • Monitor

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•
    Active Comparator: Arm II (Waitlist Control [WLC])

    Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I

    Behavioral: Exercise Intervention
    Participate in fitness program

    Behavioral: Internet-Based Intervention
    Engage in private social support messaging and Use the mobile app

    Device: Monitoring Device
    Wear an electronic accelerometer
    Other Names:
  • Monitor

    • Other: Quality-of-Life Assessment
    Ancillary studies
    Other Names:
  • Quality of Life Assessment

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Feasibility of the Technology-enhanced Fitness Program [Baseline]

      Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).

    Secondary Outcome Measures

    1. Feasibility - Retention [Baseline to post-intervention (3 months)]

      Percentage of participants who compete the 3 month assessment

    2. Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale [Baseline to post-intervention (3 months)]

      Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.

    3. Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale [Baseline to post-intervention (3 months)]

      The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.

    4. Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test [Baseline to post-intervention (3 months)]

      Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.

    5. Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) [Baseline to post-intervention (3 months)]

      Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.

    6. Feasibility - Engagement With the App [Duration of the FitSurvivor intervention (12 weeks)]

      Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any diagnosis of cancer prior to age 21

    • Off treatment for at least 6 months

    • For patients < 18 years, parents must give informed consent and patient must give assent; patients >= 18 must give informed consent

    Exclusion Criteria:

    • Any medical contraindication to exercise according to a physician or physician's designee

    • Non-English speaking

    • Current physical activity level exceeding Centers for Disease Control and Prevention (CDC) guidelines for activity (60 min of moderate-vigorous exercise/day for 5+ days/week (wk) including 3+ days of vigorous intensity activities and muscle-strengthening exercises on 3+ days/wk and bone strengthening exercises on 3+ days/wk for children < 18 and 150 min of moderate vigorous exercise or 75 min of vigorous exercise/wk and 2+ days of muscle strengthening activities for adults >= 18); the CDC guidelines are used to determine exercise prescription in our intervention; individuals already exceeding the guidelines would be unlikely to benefit from participating

    • Significant developmental delay per patient, parent, or physician report

    • Pregnant (per patient report); if participant becomes pregnant during the course of the study, she will be removed from further participation

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601
    2 Rutgers Cancer Institute of New Jersey New Brunswick New Jersey United States 08903

    Sponsors and Collaborators

    • Rutgers, The State University of New Jersey
    • National Cancer Institute (NCI)
    • Rutgers Cancer Institute of New Jersey

    Investigators

    • Principal Investigator: Katie Devine, Rutgers Cancer Institute of New Jersey

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Katie Devine, PhD, MPH, Assistant Professor of Medicine, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT02688192
    Other Study ID Numbers:
    • Pro2013003658
    • NCI-2015-01841
    • 131323
    • K07CA174728
    • P30CA072720
    First Posted:
    Feb 23, 2016
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    Participant Flow

    Recruitment Details In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).
    Pre-assignment Detail
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings over 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Period Title: Overall Study
    STARTED 25 24
    COMPLETED 13 19
    NOT COMPLETED 12 5

    Baseline Characteristics

    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC]) Total
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings over 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Total of all reporting groups
    Overall Participants 25 24 49
    Age (Count of Participants)
    <=18 years
    13
    52%
    12
    50%
    25
    51%
    Between 18 and 65 years
    12
    48%
    12
    50%
    24
    49%
    >=65 years
    0
    0%
    0
    0%
    0
    0%
    Age (years) [Mean (Full Range) ]
    Mean (Full Range) [years]
    18.88
    18.25
    18.56
    Sex: Female, Male (Count of Participants)
    Female
    15
    60%
    9
    37.5%
    24
    49%
    Male
    10
    40%
    15
    62.5%
    25
    51%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    6
    24%
    4
    16.7%
    10
    20.4%
    Not Hispanic or Latino
    19
    76%
    20
    83.3%
    39
    79.6%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    4%
    2
    8.3%
    3
    6.1%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    3
    12%
    3
    12.5%
    6
    12.2%
    White
    17
    68%
    15
    62.5%
    32
    65.3%
    More than one race
    3
    12%
    1
    4.2%
    4
    8.2%
    Unknown or Not Reported
    1
    4%
    3
    12.5%
    4
    8.2%

    Outcome Measures

    1. Primary Outcome
    Title Feasibility of the Technology-enhanced Fitness Program
    Description Feasibility will be evaluated by the number of participants who enroll and complete baseline assessment for the randomized trial. In total, 354 participants were mailed letters; 68 were contacted/screened, of which 56 were eligible and 49 enrolled (88% of those screened eligible, 14% of total potentially eligible pool).
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 25 24
    Count of Participants [Participants]
    25
    100%
    24
    100%
    2. Secondary Outcome
    Title Feasibility - Retention
    Description Percentage of participants who compete the 3 month assessment
    Time Frame Baseline to post-intervention (3 months)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 25 24
    Count of Participants [Participants]
    15
    60%
    22
    91.7%
    3. Secondary Outcome
    Title Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale
    Description Fatigue measured using the PedsQL Multidimensional Fatigue Scale. The PedsQL Multidimensional Fatigue Scale yields three subscales: general, sleep/rest, and cognitive fatigue. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.
    Time Frame Baseline to post-intervention (3 months)

    Outcome Measure Data

    Analysis Population Description
    Only participants with complete data were included in this analysis.
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 15 21
    Fatigue general (baseline)
    60.12
    (25.72)
    71.02
    (12.76)
    Fatigue general (post-intervention)
    65.18
    (23.60)
    71.40
    (13.44)
    Fatigue Sleep/Rest (baseline)
    55.95
    (20.78)
    62.88
    (15.90)
    Fatigue Sleep/Rest (post-intervention))
    63.10
    (24.78)
    65.72
    (17.95)
    Fatigue Cognitive (baseline)
    57.74
    (24.78)
    70.08
    (22.59)
    Fatigue Cognitive (post-intervention)
    63.69
    (26.27)
    75.38
    (20.45)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effects of the intervention on changes in the General Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments
    Method ANOVA
    Comments df = 33
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effects of the intervention on changes in the Sleep/Rest Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .49
    Comments
    Method ANOVA
    Comments df = 33
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effect of the intervention on changes in the Cognitive Subscale from baseline to post-intervention (3 months) were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .83
    Comments
    Method ANOVA
    Comments df = 33
    4. Secondary Outcome
    Title Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale
    Description The PedsQL Generic Core Scale is a well-validated measure of HRQOL with physical, emotional, social, and cognitive functioning domains. The PedsQL Generic Core yields two summary scores - Physical Summary and Psychosocial Summary. Scores are transformed on a 0-100 scale, with higher scores indicating better functioning.
    Time Frame Baseline to post-intervention (3 months)

    Outcome Measure Data

    Analysis Population Description
    Only participants with complete data were included in this analysis.
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 15 21
    HRQOL: Physical Summary (baseline)
    72.10
    (21.10)
    79.75
    (8.32)
    HRQOL: Physical Summary (post-intervention)
    74.11
    (20.74)
    81.68
    (9.56)
    HRQOL: Psycho social Summary (baseline)
    72.64
    (12.28)
    77.92
    (12.14)
    HRQOL: Psycho social Summary (post-intervention)
    70.00
    (16.17)
    75.92
    (11.98)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effects of the intervention on changes in the PedsQL Physical Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .98
    Comments
    Method ANOVA
    Comments df = 33
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effects of the intervention on changes in the PedsQL Psychosocial Summary score were evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .85
    Comments
    Method ANOVA
    Comments df = 29
    5. Secondary Outcome
    Title Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test
    Description Cardiorespiratory fitness was measured via submaximal treadmill testing using a modified Bruce protocol. This standardized graded treadmill test adds two warm-up stages, with the first performed at a 1.7 mph and 0% grade and the second at 1.7 mph and 5% grade. Participants performed the graded exercise test until they reached 85% of their age-predicted maximum heart rate, which was measured using a chest-worn Polar heart rate monitor. Estimated VO2 max was calculated for each participant using the multi-stage model and American College of Sports Medicine metabolic equations.
    Time Frame Baseline to post-intervention (3 months)

    Outcome Measure Data

    Analysis Population Description
    Only participants with complete data were included in this analysis.
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 15 21
    estimated VO2 max (baseline)
    36.67
    (7.03)
    40.61
    (9.60)
    estimated VO2 max (post-intervention)
    39.08
    (9.48)
    39.80
    (9.27)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .29
    Comments
    Method ANOVA
    Comments df = 29
    6. Secondary Outcome
    Title Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)
    Description Lower and upper body muscular strength/endurance were measured via 10-repetition maximum (10-RM) tests following National Strength and Conditioning Association guidelines (leg press machine for lower body and barbell bench press for upper body). Weight was increased until participants executed 10 repetitions in good form for both exercises. Estimates of 1-RM leg and bench press were made using a linear prediction equation. Higher scores indicate greater muscular strength/endurance.
    Time Frame Baseline to post-intervention (3 months)

    Outcome Measure Data

    Analysis Population Description
    Only participant with complete data were included.
    Arm/Group Title Arm I (Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    Measure Participants 15 21
    Lower Body 1-RM (baseline)
    191.93
    (80.76)
    199.78
    (84.56)
    Lower Body 1-RM (post-intervention)
    247.23
    (109.76)
    219.71
    (89.85)
    Upper Body 1-RM (baseline)
    35.78
    (22.76)
    45.51
    (25.83)
    Upper Body 1-RM (post-intervention)
    40.50
    (24.26)
    48.48
    (25.40)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effect of the intervention on changes in lower body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .019
    Comments
    Method ANOVA
    Comments df = 32
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm I (Intervention), Arm II (Waitlist Control [WLC])
    Comments Effect of the intervention on changes in upper body estimated 1-RM was evaluated using group x time in a repeated measures analysis of variance performed in SAS using PROC GLM for participants with complete data.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value .34
    Comments
    Method ANOVA
    Comments df = 32
    7. Secondary Outcome
    Title Feasibility - Engagement With the App
    Description Engagement with the app was measured by 1) number of in-app exercises completed; 2) points earned (more active = more points); 3) achievements unlocked; and 4) number of likes and comments posted within the social feed. These are count data. Achievements unlocked has possible range of 0 to 20. Number of in-app exercises completed, points earned, and number of likes and comments posted within the social feed have a possible lower limit of 0 and no upper limit; higher numbers indicate more instances of each. The full range of participant data are: number of in-app exercises completed = 0-44; points earned = 0-1,195; number of achievements unlocked = 1-20; number of likes/comments posted = 0-8.
    Time Frame Duration of the FitSurvivor intervention (12 weeks)

    Outcome Measure Data

    Analysis Population Description
    All participants from Arm I and Arm II who started the intervention were included. Those who dropped out prior to starting any sessions (n=7) were excluded from this analysis.
    Arm/Group Title ALL: Arm I (Intervention) and Arm II (WLC)
    Arm/Group Description All participants from Arm I and Arm II who started the 12-week intervention.
    Measure Participants 42
    # In-app workouts
    6.50
    (10.69)
    Total in-app points earned
    165.48
    (287.74)
    # Achievements unlocked
    8.50
    (4.63)
    # of Likes/Comments posted
    0.62
    (1.51)

    Adverse Events

    Time Frame From the time first participant signed consent form until completion of all study related procedures. 3 years, 8 months.
    Adverse Event Reporting Description Project Coordinator maintains the adverse event log. All unexpected and/or serious adverse events occurring during the active portion of the intervention or up to 30 days after the last fitness program session, are reported to the Rutgers Cancer Institute of New Jersey Human Research Services and the Institutional Review Board. Adverse even log is also presented to Data Safety Monitoring Board for review.
    Arm/Group Title Arm I (FitSurvivor Intervention) Arm II (Waitlist Control [WLC])
    Arm/Group Description Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation Participate in a fitness program which includes: 8 group meetings of 90 minutes weekly Behavioral internet based intervention engage in private social support messaging within the app and Facebook private groups and mobile app Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies Assessment including Wear an electronic accelerometer Quality of life assessment Physical fitness evaluation After waiting 6 months they will begin the fitness program as described in Arm I Exercise Intervention: Participate in fitness program Internet-Based Intervention: Engage in private social support messaging and Use the mobile app Monitoring Device: Wear an electronic accelerometer Quality-of-Life Assessment: Ancillary studies
    All Cause Mortality
    Arm I (FitSurvivor Intervention) Arm II (Waitlist Control [WLC])
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/24 (0%)
    Serious Adverse Events
    Arm I (FitSurvivor Intervention) Arm II (Waitlist Control [WLC])
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/24 (0%)
    Other (Not Including Serious) Adverse Events
    Arm I (FitSurvivor Intervention) Arm II (Waitlist Control [WLC])
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/25 (0%) 0/24 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Katie Devine
    Organization Rutgers Cancer Inst. of NJ
    Phone 7322357549
    Email katie.devine@rutgers.edu
    Responsible Party:
    Katie Devine, PhD, MPH, Assistant Professor of Medicine, Rutgers, The State University of New Jersey
    ClinicalTrials.gov Identifier:
    NCT02688192
    Other Study ID Numbers:
    • Pro2013003658
    • NCI-2015-01841
    • 131323
    • K07CA174728
    • P30CA072720
    First Posted:
    Feb 23, 2016
    Last Update Posted:
    Apr 9, 2021
    Last Verified:
    Apr 1, 2021