Fit2ThriveMB: Optimization of a Physical Activity Promotion Intervention for Metastatic Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Change in Steps
研究概览
简要总结
The purpose of this study is to examine which of four components of a digital health intervention using an App and Fitbit meaningfully contribute to increased physical activity in Metastatic Breast Cancer Patients.
Participants will be asked to:
- Wear a Fitbit and use an app, use 0 to 3 other components for 24 weeks and attend 6 or 12 coaching coaching calls in the first 12 weeks to increase daily steps.
- Complete a questionnaire at baseline, week 12 and week 24
- Complete functional performance test (FPT) via Zoom at baseline, week 12 and week 24
- Wear a research activity monitor (Accelerometer) for 7 days at baseline, week 12 and week 24
详细描述
Multiphase Optimization Strategy (MOST) methodology will be used to determine which intervention components or component combinations optimally increase daily steps in a 12-week intervention with a 12-week follow-up. MOST is a framework adapted from engineering that uses highly efficient factorial experiments to evaluate individual, and combined, effects of intervention components to determine which ones can be reduced, eliminated, or replaced to improve efficiency. Insufficiently active people with metastatic breast cancer (MBC) will receive a core intervention consisting of the FIt2ThriveMB app and Fitbit and be randomly assigned to four components, each with two-levels, under consideration for inclusion in the optimized intervention: 1) EHR-integration (on v. off); 2) coaching dose (weekly v. bi-weekly; 3) social+ (on v. off) and 4) goal-setting type (highly tailored v. static). The effects of increasing PA on symptom burden, other intensity activities (i.e. moderate to vigorous, light and sedentary), and functional performance and potential mediators and moderators of component effects will also be examined. Knowledge gained from this study will inform the development of more effective and scalable interventions to improve health and disease outcomes in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 sex assigned at birth, age 18 years or older
- •Diagnosed with metastatic breast cancer or locally advanced disease not amenable to surgical resection.
- •Self-report engagement in <150 min/week of moderate to vigorous physical activity
- •Ownership of an Android or iPhone with an up-to-date version of the operating system
- •Internet access to complete assessments
- •Fluency in spoken and written English
- •Willingness to obtain medical clearance to participate.
排除标准
- •Untreated brain metastases
- •Breast cancer with metastases to only the axillary lymph nodes.
- •Self-reported absolute contraindications to exercise (i.e., non-ambulatory, acute myocardial infarction, severe cognitive or functional impairment)
- •Currently pregnant or plans to become pregnant
- •Plans to move out of the United States in next 12 months
- •Current enrollment in another dietary or physical activity trial
研究组 & 干预措施
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Weekly Coaching (Behavioral)
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
2- Core, EHR, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
3- Core, EHR, Weekly Coaching, Static Goal Setting
干预措施: Core Intervention (Behavioral)
3- Core, EHR, Weekly Coaching, Static Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
3- Core, EHR, Weekly Coaching, Static Goal Setting
干预措施: Weekly Coaching (Behavioral)
3- Core, EHR, Weekly Coaching, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
干预措施: Core Intervention (Behavioral)
4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
4- Core, EHR, Bi-Weekly Coaching, Static Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
干预措施: Core Intervention (Behavioral)
5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
干预措施: Weekly Coaching (Behavioral)
5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
5- Core, EHR, Weekly Coaching, Social+, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Core Intervention (Behavioral)
6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
6- Core, EHR, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Weekly Coaching (Behavioral)
7- Core, EHR, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: EHR Integration (On v. Off) (Behavioral)
8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
8- Core, EHR, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
9- Core, Weekly Coaching, Social+, Static Goal Setting
干预措施: Core Intervention (Behavioral)
9- Core, Weekly Coaching, Social+, Static Goal Setting
干预措施: Weekly Coaching (Behavioral)
9- Core, Weekly Coaching, Social+, Static Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
9- Core, Weekly Coaching, Social+, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Core Intervention (Behavioral)
10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
10- Core, Bi-Weekly Coaching, Social+, Static Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
11- Core, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
11- Core, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Weekly Coaching (Behavioral)
11- Core, Weekly Coaching, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
12- Core, Bi-Weekly Coaching, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Weekly Coaching (Behavioral)
13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
13- Core, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Social+ (on v. off) (Behavioral)
14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
14- Core, Bi-Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Highly Tailored Goal Setting (Behavioral)
15- Core, Weekly Coaching, Static Goal Setting
干预措施: Core Intervention (Behavioral)
15- Core, Weekly Coaching, Static Goal Setting
干预措施: Weekly Coaching (Behavioral)
15- Core, Weekly Coaching, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
16- Core, Bi-Weekly Coaching, Static Goal Setting
干预措施: Core Intervention (Behavioral)
16- Core, Bi-Weekly Coaching, Static Goal Setting
干预措施: Static Goal Setting (Behavioral)
16- Core, Bi-Weekly Coaching, Static Goal Setting
干预措施: Bi-Weekly Coaching (Behavioral)
1- Core, EHR, Weekly Coaching, Social+, Highly Tailored Goal Setting
干预措施: Core Intervention (Behavioral)
结局指标
主要结局
Change in Steps
时间窗: Baseline, 12 and 24 weeks
The ActiGraph accelerometer will be used. Participants will wear the device during all waking hours for 7 consecutive days, except when bathing or swimming, on their non-dominant hip.
次要结局
- ActiGraph measured MVPA(Baseline, 12 and 24 weeks)
- ActiGraph measured light activity(Baseline, 12 and 24 weeks)
- ActiGraph measured sedentary behavior(Baseline, 12 and 24 weeks)
- Godin Leisure Time Exercise Questionnaire(Baseline, 12 and 24 weeks)
- PROMIS 29 Profile(Baseline, 12 and 24 weeks)
- Short Physical Performance Battery (SPPB) Total Score(Baseline, 12 weeks, 24 weeks)
研究者
Siobhan M Phillips
Professor
Northwestern University