Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer II (Smart Pace II)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Fitbit wear time
研究概览
简要总结
There is a critical need for physical activity interventions in colorectal cancer (CRC). The investigators have developed a digital health physical activity intervention, Smart Pace, which includes a wearable tracker (Fitbit) and text messaging and aims to have patients build up to 150 min/wk of moderate activity. In this study, the investigators propose to expand and improve Smart Pace, including: 1) enrolling patients during chemotherapy; 2) tailoring text messages to individual preferences and treatment timing; and 3) adding resources to support home-based exercise. The study is a 12-week pilot randomized controlled trial (RCT) to evaluate the feasibility of this novel digital health physical activity intervention among 48 CRC patients on chemotherapy. The specific aims are to: 1) Determine the feasibility of the intervention via adherence and attrition, and determine the acceptability of the intervention via questionnaires and semi-structured interviews . 2) Estimate the effect of the intervention vs. usual care on physical activity, QOL, and symptoms at 12-weeks . And 3) Explore the impact of the intervention vs. usual care on fitness, weight, waist circumference, and blood pressure at 12-weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with colon or rectal adenocarcinoma
- •Expected to receive at least 12 weeks of chemotherapy
- •Able to speak and read English
- •Access to a mobile phone with Internet and text messaging capabilities
- •≥4 weeks since last major surgery and fully recovered
- •≥18 years old
- •Physician consent to participate in unsupervised moderate intensity physical activity
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
排除标准
- •Engaging in 150 minutes/week or more of moderate physical activity, 75 minutes/week or more of vigorous physical activity, or an equivalent combination
- •Hypertension that is not well-controlled (≥160/90) on anti-hypertensive therapy
- •Any contraindications to exercise, including, but not limited to: brain metastases; current congestive heart failure (New York Heart Association Class II, III or IV); serious or nonhealing wound, ulcer, or bone fracture; spinal cord compromise or instrumentation due to metastatic disease; peripheral neuropathy ≥grade 3; advanced Chronic Obstructive Pulmonary Disease (COPD) on oxygen
- •Serious cardiovascular event within 6 months including, but not limited to, transient ischemic attack (TIA), cerebrovascular accident (CVA), or myocardial infarction (MI)
- •Has been told by a doctor that he/she has a heart condition and recommended to only engage in medically supervised activity
结局指标
主要结局
Fitbit wear time
时间窗: up to 12 weeks from study start
Number of study days Fitbit is worn
Acceptability of the intervention
时间窗: At 12 weeks from study start
Acceptability will be assessed with an investigator created questionnaire among participants in the intervention arm.
Text message response rate
时间窗: up to 12 weeks from study start
次要结局
- Objective physical activity(At 0 weeks and 12 weeks from study start)
- Fatigue(At 0 and 12 weeks from study start)
- Cardiorespiratory fitness(At 0 and 12 weeks from study start)
- Anthropometrics, Waist circumference(At 0 and 12 weeks from study start)
- Anthropometrics, Body weight(At 0 and 12 weeks from study start)
- Sleep quality(At 0 and 12 weeks from study start)
- Health-related quality of life in cancer patients(At 0 and 12 weeks from study start)
- Health-related quality of life in colorectal cancer patients(At 0 and 12 weeks from study start)
- Neuropathy(At 0 and 12 weeks from study start)
- Anxiety(At 0 and 12 weeks from study start)
- Depression(At 0 and 12 weeks from study start)
- Leisure-time physical activity(At 0 and 12 weeks from study start)
- Perceived barriers to physical activity(At 0 and 12 weeks from study start)
- Exercise Confidence(At 0 and 12 weeks from study start)
- Social support(At 0 and 12 weeks from study start)