Technology-Supported Physical Activity Intervention for Metastatic Breast Cancer Survivors: Fit2ThriveMB
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
- Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
研究概览
简要总结
This study will test the feasibility and acceptability of increasing PA in metastatic breast cancer (MBC) patients using a smartphone app, fitbit and coaching.
详细描述
The primary purpose of the present study is to pilot test the feasibility and acceptability of a 12 week mHealth intervention to increase PA in metastatic breast cancer (MBC) patients using a two-arm randomized control trial (RCT). We will also examine the effects of the intervention on symptom burden, quality of life, and functional performance. Inactive MBC patients will be assigned to Fit2ThriveMB or education control. Participants assigned to the Fit2ThriveMB will receive the Fit2ThriveMB smartphone app, Fitbit, and coaching calls. Participants in the education control will be asked to download the app cancer.net from the American Society of Clinical Oncology, will receive educational materials and calls during the intervention period and the Fitbit following completion of 12 week assessments.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female; ≥18 years of age
- •Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection (Metastases to the auxiliary lymph nodes, and nowhere else in the body, do not qualify).
- •Fluent in spoken and written English
- •Own a smartphone
- •Have access to the internet to complete assessments
- •Self-report engaging in <150 minutes of moderate to vigorous PA per week.
排除标准
- •Untreated brain metastases
- •Uncontrolled cardiovascular disease or other major contraindications (i.e. non- ambulatory, severe cognitive or functional limitations) to PA participation
- •Current enrollment in another dietary or PA trial
结局指标
主要结局
Number of Participants Retained During the 12 Week Technology Supported Physical Activity Intervention Period
时间窗: 12 weeks
Feasibility will be assessed via participant retention during the intervention period \[(# of participants randomized- # of participants who drop out or are lost to follow-up)/ # randomized\].
Acceptability of a 12 Week Technology Supported Physical Activity Intervention to Metastatic Breast Cancer Patients
时间窗: 12 weeks
Acceptability will be measured via a process evaluation of perceptions of MBC patients' experiences with Fit2ThriveMB. Acceptability will be measured as the number of intervention participants who are satisfied/very satisfied with their overall study experience.
Adherence to a 12 Week Technology Supported Physical Activity Intervention by Metastatic Breast Cancer Patients
时间窗: 12 weeks
Adherence during the 12 week intervention will be monitored continuously using Fit2ThriveMB app. This measure the average percentage of days each participant in the Fit2ThriveMB intervention group wore the Fitbit.
次要结局
- Change in Quality of Life From From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Physical Activity Minutes From Before to After a 12 Week Technology Supported Physical Activity Intervention in Metastatic Breast Cancer Patients(Baseline and 12 weeks)
- Change in Anxiety From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Depression From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Fatigue From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Pain Interference From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Physical Function From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Arm Curl Test and Two-Minute Step Test From the Senior Fitness Test Measures Between Baseline and 12 Weeks(Baseline and 12 weeks)
- Change in Sleep Disturbance From Baseline to 12-weeks(Baseline and 12 weeks)
- Change in Short Physical Performance Battery (SPPB) Scores From Baseline to 12 Weeks(Baseline and 12 weeks)
- Change in 6-minute Walk Test Distance Between Baseline and 12-weeks.(Baseline and 12 weeks)
- Change in One Leg Stand Test and 8-foot-up-and go From the Senior Fitness Test Measures Between Baseline and 12 Weeks(Baseline and 12 weeks)
研究者
Siobhan M Phillips
Associate Professor
Northwestern University