Promoting Physical Activity in Young Adult Cancer Survivors Using mHealth and Adaptive Tailored Feedback Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Minutes of total physical activity at 6 months: objective
研究概览
简要总结
To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to PA. The purpose of this randomized controlled trial is to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing physical activity among young adult cancer survivors.
详细描述
There are over half a million young adult cancer survivors in the United States. Young adult cancer survivors are an underserved and vulnerable subgroup of survivors that experience increased risk over time for obesity and chronic diseases such as diabetes and cardiovascular disease. Increasing physical activity is a promising behavioral intervention that has positive effects on physical function, body composition, cardiovascular fitness, health-related quality of life, and depression, and may prevent cancer recurrence, new cancers and improve survival. To date, few interventions have been designed specifically to promote physical activity in young adult cancer survivors, nor used novel technologies for delivery; none have been successful in promoting long-term adherence to physical activity. This is a randomized controlled trial to test the efficacy of a theory-based, mobile physical activity intervention with adaptive goal-setting and tailored feedback that is aimed at increasing PA among young adult cancer survivors. Young adult cancer survivors (n=280), diagnosed between ages 18-39, will be recruited and randomized into one of two conditions: 1) activity tracker + Facebook group (Self-help) or 2) activity tracker + Facebook group + adaptive goal-setting and tailored feedback (Intervention). Young adult cancer survivors will receive a 6-month intervention followed by an additional 6 months of tapered contacts. Assessments of objectively-measured physical activity and other outcomes will be conducted at baseline, 3, 6, and 12 months.
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)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently age 18-39
- •Diagnosed with invasive malignancy between the ages of 18-39 years
- •Diagnosed with invasive malignancy in the last 10 years with no evidence of progressive disease or second primary cancers
- •Completed active cancer directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention), except may be receiving "maintenance" therapy to prevent recurrences
- •Have the ability to read, write and speak English
- •No pre-existing medical condition(s) that preclude adherence to an unsupervised exercise program, including cardiovascular disease, congestive heart failure, pulmonary conditions, renal disease, and severe orthopedic conditions
- •Not adhering to the American College of Sports Medicine recommendation of at least 150 moderate-to-vigorous physical activity minutes/week
- •Have access to the Internet on at least a weekly basis
- •Possession and usage of an Internet e-mail address or willingness to sign up for a free email account (e.g., gmail)
- •Have mobile phone with text messaging plan
- •Willing to be randomized to either arm
- •Successful completion of accelerometer-assessed activity (i.e., at least 10 hours/day on 4 of 7 days) and return of the accelerometer in a pre-paid envelope at baseline
排除标准
- •History of heart attack or stroke within past 6 months
- •Untreated hypertension, hyperlipidemia, or diabetes, unless permission is provided by their health care provider
- •Health problems which preclude ability to walk for physical activity
- •Report a diagnosis of psychiatric diseases (schizophrenia, bipolar disorder, depression leading to hospitalization in the past year), drug or alcohol dependency.
- •Report a past diagnosis of or treatment for a DSM-IV-TR eating disorder (anorexia nervosa or bulimia nervosa)
- •Current participation in another physical activity or weight control program
- •Currently using prescription weight loss medications
- •Currently pregnant, pregnant within the past 6 months, or planning to become pregnant within the next 6 months
- •Currently exercising > 150 minutes/week of moderate-to-vigorous intensity physical activity
结局指标
主要结局
Minutes of total physical activity at 6 months: objective
时间窗: Baseline, 6 months
Change in objective levels of physical activity, as measured by accelerometry (ActiGraph), from baseline to 6 months. Participants will wear an accelerometer on their wrist during a 7 day period.
次要结局
- Minutes of total physical activity at 6 months: self-report(Baseline, 6 months)
- Steps per day: Fitbit(Baseline, 6 months, 12 months)
- Minutes of moderate-to-vigorous intensity physical activity: objective(Baseline, 6 months, 12 months)
- Steps per day: objective(Baseline, 6 months, 12 months)
- Behavioral capability(Baseline, 3 months, 6 months, 12 months)
- Minutes of total physical activity at 12 months: objective(Baseline, 6 months, 12 months)
- Weight(Baseline, 6 months, 12 months)
- Self-efficacy for exercise(Baseline, 3 months, 6 months, 12 months)
- Minutes of light-intensity physical activity: self-report(Baseline, 6 months, 12 months)
- Minutes of moderate-to-vigorous intensity physical activity: self-report(Baseline, 6 months, 12 months)
- Self-regulation(Baseline, 3 months, 6 months, 12 months)
- Minutes of total physical activity at 12 months: self-report(Baseline, 6 months, 12 months)
- Minutes of light-intensity physical activity: objective(Baseline, 6 months, 12 months)
- Health-related quality of life: Medical Outcomes Study 36-Item Short Form (SF-36)(Baseline, 3 months, 6 months, 12 months)
- Health-related quality of life: Functional Assessment of Cancer Therapy-General (FACT-G)(Baseline, 3 months, 6 months, 12 months)
- Sedentary behavior(Baseline, 6 months, 12 months)
- Social support for exercise(Baseline, 3 months, 6 months, 12 months)