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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-01841 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 131323 | Other Identifier | Rutgers Cancer Institute of New Jersey | |
| K07CA174728 | U.S. NIH Grant/Contract | View source | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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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.
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of the technology-enhanced (electronic accelerometer + app + 8 weekly group sessions) fitness program in a pilot randomized clinical trial.
SECONDARY OBJECTIVES:
I. Determine the effectiveness of the technology-enhanced fitness program on participants' cardiorespiratory fitness and muscular fitness.
II. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Intervention) | Active Comparator | Assessment including
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| Arm II (Waitlist Control [WLC]) | Active Comparator | Assessment including
After waiting 6 months they will begin the fitness program as described in Arm I |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Intervention | Behavioral | Participate in fitness program |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Technology-enhanced Fitness Program | 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). | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - Retention | Percentage of participants who compete the 3 month assessment | Baseline to post-intervention (3 months) |
| Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Devine | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States | ||
| Rutgers Cancer Institute of New Jersey |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Intervention) | Assessment including
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 |
| FG001 | Arm II (Waitlist Control [WLC]) | Assessment including
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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants in Group Qualitative, Group RCT ARM I and Group RCT Arm II, who completed any study activities after signing the consent form, are included. We excluded 2 participants (from Group Qualitative) who signed the consent form, but never completed qualitative interview.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Intervention) | Assessment including
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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Technology-enhanced Fitness Program | 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). | Posted | Count of Participants | Participants | Baseline |
|
From the time first participant signed consent form until completion of all study related procedures. 3 years, 8 months.
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (FitSurvivor Intervention) | Assessment including
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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katie Devine | Rutgers Cancer Inst. of NJ | 7322357549 | katie.devine@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2018 | May 10, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008991 | Monitoring, Physiologic |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Internet-Based Intervention | Behavioral | Engage in private social support messaging and Use the mobile app |
|
| Monitoring Device | Device | Wear an electronic accelerometer |
|
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| Quality-of-Life Assessment | Other | Ancillary studies |
|
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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.
| Baseline to post-intervention (3 months) |
| Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | 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. | Baseline to post-intervention (3 months) |
| Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | 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. | Baseline to post-intervention (3 months) |
| Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | 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. | Baseline to post-intervention (3 months) |
| Feasibility - Engagement With the App | 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. | Duration of the FitSurvivor intervention (12 weeks) |
| New Brunswick |
| New Jersey |
| 08903 |
| United States |
| BG001 | Arm II (Waitlist Control [WLC]) | Assessment including
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Arm II (Waitlist Control [WLC]) | Assessment including
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 |
|
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| Secondary | Feasibility - Retention | Percentage of participants who compete the 3 month assessment | Posted | Count of Participants | Participants | Baseline to post-intervention (3 months) |
|
|
|
| Secondary | Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale | 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. | Only participants with complete data were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention (3 months) |
|
|
|
|
| Secondary | Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale | 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. | Only participants with complete data were included in this analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline to post-intervention (3 months) |
|
|
|
|
| Secondary | Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test | 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. | Only participants with complete data were included in this analysis. | Posted | Mean | Standard Deviation | ml/kg/min | Baseline to post-intervention (3 months) |
|
|
|
|
| Secondary | Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body) | 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. | Only participant with complete data were included. | Posted | Mean | Standard Deviation | kg | Baseline to post-intervention (3 months) |
|
|
|
|
| Secondary | Feasibility - Engagement With the App | 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. | 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. | Posted | Mean | Standard Deviation | counts | Duration of the FitSurvivor intervention (12 weeks) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Arm II (Waitlist Control [WLC]) | Assessment including
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 | 0 | 24 | 0 | 24 | 0 | 24 |
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| Fatigue Sleep/Rest (baseline) |
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| Fatigue Sleep/Rest (post-intervention)) |
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| Fatigue Cognitive (baseline) |
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| Fatigue Cognitive (post-intervention) |
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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. |
| ANOVA |
df = 33 |
| .49 |
| Superiority |
| 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. | ANOVA | df = 33 | .83 | Superiority |
| HRQOL: Psycho social Summary (baseline) |
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| HRQOL: Psycho social Summary (post-intervention) |
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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.
| ANOVA |
df = 29 |
| .85 |
| Superiority |
| Upper Body 1-RM (baseline) |
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| Upper Body 1-RM (post-intervention) |
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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.
| ANOVA |
df = 32 |
| .34 |
| Superiority |
| Title | Measurements |
|---|---|
|
| # of Likes/Comments posted |
|