Adolescents and Young Adults Becoming Physically Active After Cancer Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- Changes in weekly minutes of moderate-vigorous intensity physical activity
研究概览
简要总结
In this randomized controlled trial the investigators will determine whether a mobile health intervention can increase physical activity levels in AYA cancer survivors over a one year period. The investigators will recruit 320 cancer survivors in Alberta who were diagnosed with a first cancer between the ages of 15 to 39 years and are within one year of treatment completion. Participants will be randomized into either the control group (educational information) or the intervention group (educational information; personalized physical activity plan; activity tracker watch; access to a private, online survivor community; motivational text messages and check-in calls/e-mails). All participants will complete fitness testing and questionnaires at baseline, 6 months and 12 months. A final measurement at 24 months will test long-term effectiveness.
详细描述
Background:
There is a need for adolescent and young adult (AYA) cancer research because the number of new cancers in young people is increasing and the survivor population is growing. Interventions that try to reduce problems that affect people after cancer are particularly important since its treatments can have negative effects on survivors' physical and mental health even decades after diagnosis.
Aim:
Given the many positive effects of physical activity (e.g. improved fitness and quality of life), the study aims to encourage AYA cancer survivors to be more physically active as they shift from treatment to survivorship care. The main goal of this study is to see if a home-based, mobile health (mHealth) physical activity intervention can increase physical activity levels by at least 90 minutes/week compared to baseline in AYA cancer survivors.
Methods:
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The study team, with the exception of the study coordinator, will be blinded to reduce bias.
入排标准
- 年龄范围
- 15 Years 至 39 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lives in Alberta
- •Diagnosed with invasive malignancy in Alberta
- •Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) in the last 12 months, except for "maintenance" therapy to prevent recurrences
- •Have the ability to read, write and speak English
- •Have access to the Internet on at least a weekly basis
- •Have a mobile phone with a text messaging plan
- •Willing to be randomized to either arm.
排除标准
- •Health problems which preclude the ability to walk for physical activity, as measured by the Physical Activity Readiness Questionnaire (PAR-Q)
- •Currently pregnant or planning to become pregnant within the next 6 months
- •Currently taking part in > 300 minutes/week of moderate-to-vigorous intensity physical activity on a regular basis
研究组 & 干预措施
mHealth Physical Activity Intervention
The intervention arm will receive a 12 month mobile health (mHealth) physical activity intervention with a goal of increasing their moderate-vigorous intensity physical activity levels by 90 minutes per week above baseline
干预措施: Physical Activity (Behavioral)
Control
Controls will receive general health education materials
结局指标
主要结局
Changes in weekly minutes of moderate-vigorous intensity physical activity
时间窗: Baseline, 6 months, 12 months, 24 months
Measured by Actigraph
次要结局
- Changes in upper body muscular endurance(Baseline, 6 months,12 months)
- Changes in lower body muscular endurance(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Mental Health Component subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Social Functioning subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Impact of Cancer subscale(Baseline, 6 months,12 months)
- Changes in weekly minutes of sedentary time(Baseline, 6 months,12 months)
- Changes in the Pittsburgh Sleep Quality Index (PSQI) Global Sleep Quality Score(Baseline, 6 months,12 months)
- Changes in upper body muscular strength(Baseline, 6 months,12 months)
- Changes in weight(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Physical Health Component subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Bodily Pain subscale(Baseline, 6 months,12 months)
- Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Comments From Others subscale(Baseline, 6 months,12 months)
- Changes in waist and hip circumference(Baseline, 6 months,12 months)
- Changes in grip strength(Baseline, 6 months,12 months)
- Changes in frailty(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Physical Functioning subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Role-emotional subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 Mental Health subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Education subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Practical subscale(Baseline, 6 months,12 months)
- Changes in lower body muscular strength(Baseline, 6 months,12 months)
- Changes in the Comprehensive Score for Financial Toxicity (COST)(Baseline, 6 months,12 months)
- Changes in weekly minutes of sleep(Baseline, 6 months,12 months)
- Changes in body mass index (BMI)(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Vitality subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Physical subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Cognitive subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Cancer Worry subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Employment subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) Role-physical subscale(Baseline, 6 months,12 months)
- Changes in the Short Form 36 (SF-36) General Health subscale(Baseline, 6 months,12 months)
- Changes in the Cancer Distress Scales for AYAs Emotional subscale(Baseline, 6 months,12 months)
- Changes in the Functional Assessment of Cancer Therapy Fatigue (FACT-F)(Baseline, 6 months,12 months)
- Changes in the Functional Assessment of Cancer Therapy Cognitive Function Perceived Cognitive Impairment subscale(Baseline, 6 months,12 months)
- Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Perceived Cognitive Abilities subscale(Baseline, 6 months,12 months)
- Changes in the Functional Assessment of Cancer Therapy Cognitive Function (FACT-Cog) Impact on Quality of Life subscale(Baseline, 6 months,12 months)
- Changes in cardiorespiratory fitness(Baseline, 6 months,12 months)