An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
研究概览
简要总结
The purpose of this study is to assess the best time to deliver a message to increase physical activity and how often participants will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
详细描述
The primary objective of this study is to test a theory-based, micro-randomized trial to determine the optimal state to deliver a message to increase physical activity by determining the probability older cancer survivors will be physically active in the one hour following a messaging prompt. The secondary, exploratory objective is to determine the probability older cancer survivors will experience a pain episode in the 24 hours following their receipt of a message to increase physical activity.
Eligibility criteria is deliberately incomplete to preserve the scientific integrity of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 65 years.
- •Patients with a history of bladder, breast, cervical, colorectal, endometrial, lung, and prostate cancer diagnosis and treatment.
- •Fluent in spoken and written English.
- •Patient has access to smartphone
- •Ability to understand a written informed consent document, and the willingness to sign it.
排除标准
- •Patient has metastatic disease.
- •Patient has cancer recurrence.
研究组 & 干预措施
Micro-randomized trial study arm
In this one-armed, 4-week trial, participants will receive prompts to report their pain symptoms 4 times throughout the day. Participants may receive up to 4 reminders to move messages throughout the day to promote participants to engage in physical activity. The receipt of messages is randomized each day. Participants will wear a research-grade activity monitor throughout the duration of their participation in the intervention to measure physical activity behaviors.
干预措施: Physical Activity Promotion Intervention (Behavioral)
结局指标
主要结局
ActiGraph accelerometer measured physical activity behaviors (sedentary, light, moderate, vigorous intensity).
时间窗: 4 weeks
Physical activity will be measured using an ActiGraph accelerometer. Data will be aggregated into physical activity estimations (sedentary, light, moderate, vigorous, steps, etc.) using standard methods. Outcome of interest will be probability older cancer survivors are physically active in the 30 minutes following the receipt of a messaging prompt to promote physical activity.
11-point box scale to assess pain on a scale of 0 (no pain) to 10 (worst possible pain).
时间窗: 4 weeks
Pain state will be assessed by response to the pain rating measured by the 11-Point Box Scale in the study app. Participants will receive a smart phone prompt to rate their pain 4 times per day. Outcome of interest will be probability older cancer survivors experience a pain episode in the 24 hours following the receipt of a messaging prompt to increase physical activity.
次要结局
未报告次要终点
研究者
Whitney Morelli
PhD, Assistant Professor
Medical College of Wisconsin