Designing With Dissemination in Mind: Optimization of a mHealth Physical Activity Intervention for Breast Cancer Survivors
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
- Adherence to a 12 Week Technology Supported Physical Activity Intervention
研究概览
简要总结
The overall objective of the proposed research is to pilot test the feasibility and acceptability of a set of more scalable technology-supported physical activity promotion intervention strategies in breast cancer survivors using tMultiphase Optimization Strategy Trial (MOST) methodology. MOST involves highly efficient randomized experimentation to assess the effects of individual intervention strategies, and thereby identify which strategies and what strategy levels make the important contributions to the overall program's effect on physical activity. This information then guides assembly of an optimized physical activity program, that achieves target outcomes with least resource consumption and participant burden. The resulting intervention will have great potential for scalability because it uses technology (smartphones) participants already own and requires no on-site visits.
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 (Participant)
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
- •Diagnosed with Stage I-III breast cancer within the last 5 years
- •Have completed last cancer treatment (adjuvant chemotherapy, radiation therapy or surgery) at least 3 months prior to enrollment
- •English speaking
- •Currently participate in less than 60 minutes of moderate and vigorous physical activity per week
- •Own a smartphone
- •Have access to a computer with Internet
- •Participants may be using adjuvant endocrine therapies.
- •Willing to be waitlisted for future wave if current wave reaches capacity
排除标准
- •Women will be excluded if they report any of the following:
- •Respiratory, joint or cardiovascular problems precluding physical activity
- •Metastatic disease
- •Planned elective surgery during duration of the intervention/follow-up that would interfere with participation (e.g., breast reconstructive surgery).
- •ONLY IF PARTICIPATING IN OPTIONAL BLOOD COLLECTION:
- •A prior cardiovascular event (i.e. stroke, myocardial infarction)
- •Have been diagnosed with an acute or chronic immune system medical conditions, or conditions that impact immune and endocrine function (e.g., CFS, Lupus, rheumatoid arthritis, Hepatitis C, or immunosuppressive treatment requiring conditions)
结局指标
主要结局
Adherence to a 12 Week Technology Supported Physical Activity Intervention
时间窗: 12 weeks
Adherence during the 12 week intervention will be monitored continuously using study app. This measures the average percentage of days each participant randomized wore the Fitbit during weeks 1 to 12.
Participant Retention
时间窗: 12 weeks
Percentage of participants retained at the end of the 12 week intervention of those randomized \[(# of participants randomized who completed at least 1 outcome assessment measure at 12 weeks)/ # randomized\*100\].
Intervention Reach
时间窗: Baseline
Percentage of individuals randomized of those who were sent a study screening survey
次要结局
- Change in Moderate to Vigorous Physical Activity From Before to After a 12-Week Intervention(Change from baseline to 12 weeks)
- Change in Fatigue From Before to After a 12-Week Intervention(Change from baseline to 12 weeks)
- Change in Fatigue From Pre-Intervention to 24-Week Follow-up(Change from baseline to 24 weeks)
- Change in Depression From Pre-Intervention to 24-week Follow-up(Change from baseline to 24 weeks)
- Change in C-reactive Protein (CRP) From Before to After a12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in Blood Glucose From Before to After a 12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in Blood Glucose From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in High Density Lipoprotein Cholesterol (HDL) From Before to After a12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in Depression From Before to After a 12-Week Intervention(Change from baseline to 12 weeks)
- Adherence to During the Full 24-Week Study Period(24 weeks)
- Participant Retention at 24 Week Follow-up(24 weeks)
- Change in Interleukin-10 (IL-10) From Before to After a 12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in Tumor Necrosis Factor-alpha (TNFα) From Before to After a12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in C-reactive Protein (CRP) From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in High Density Lipoprotein Cholesterol (HDL) From Pre-Intervention to 24-week Follow-up(Optional)(Change from baseline to 24 weeks)
- Change in Moderate to Vigorous Physical Activity From Pre-Intervention to 24-week Follow-up(Change from baseline to 24 weeks)
- Treatment Effects for Physical Function From Pre-Intervention to 24-week Follow-up(Change from baseline to 24 weeks)
- Change in Triglycerides From Before to After a 12 Week Intervention (Optional)(Change from baseline to 12 weeks)
- Change in Triglycerides From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in Physical Function From Before to After a 12-Week Intervention(Change from baseline to 12 weeks)
- Change in Interleukin-6 (IL-6) From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in Interleukin-10 (IL-10) From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in Tumor Necrosis Factor-alpha (TNFα) From Pre-Intervention to 24-week Follow-up (Optional)(Change from baseline to 24 weeks)
- Change in Interleukin-6 (IL-6) From Before to After a12 Week Intervention (Optional)(Change from baseline to 12 weeks)
研究者
Siobhan M Phillips
Assistant Professor
Northwestern University