Teens Living With Cancer Fitness Improvement Training (TLCFIT): A Novel Mobile Health Fitness Program for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Feasibility of the Technology-enhanced Fitness Program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Internet-Based Intervention (Behavioral)
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
干预措施: Monitoring Device (Device)
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
干预措施: Quality-of-Life Assessment (Other)
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
干预措施: Exercise Intervention (Behavioral)
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
干预措施: Internet-Based Intervention (Behavioral)
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
干预措施: Monitoring Device (Device)
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
干预措施: Quality-of-Life Assessment (Other)
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
干预措施: Exercise Intervention (Behavioral)
结局指标
主要结局
Feasibility of the Technology-enhanced Fitness Program
时间窗: 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).
次要结局
- Health Related Quality of Life (HRQL) Measured Using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scale(Baseline to post-intervention (3 months))
- Fatigue Measured Using the PedsQL Multidimensional Fatigue Scale(Baseline to post-intervention (3 months))
- Feasibility - Retention(Baseline to post-intervention (3 months))
- Change in Cardiorespiratory Fitness Measured Using Submaximal Treadmill Test(Baseline to post-intervention (3 months))
- Feasibility - Engagement With the App(Duration of the FitSurvivor intervention (12 weeks))
- Change in Muscle Strength/Endurance Measured Using 10-repetition Maximum Strength Tests (Upper and Lower Body)(Baseline to post-intervention (3 months))
研究者
Katie Devine, PhD, MPH
Assistant Professor of Medicine
Rutgers, The State University of New Jersey