Fit2ThriveMIND: Optimizing a mHealth Physical Activity Intervention With Mindful Awareness Lessons in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
研究概览
简要总结
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
详细描述
The primary purpose of the present study is to apply MOST methodology to determine which types of social support and mindfulness training intervention components optimally increase MVPA adoption and maintenance in Breast Cancer Survivors (BCS) in a 24-week intervention with a 48-week follow-up. The researchers will also examine the effects of changes in MVPA on symptom burden, time spent in intensities of other activities (i.e. light and sedentary), and sleep quality and duration.
Aim 1: To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 24 and 48 weeks.
Aim 2: To examine how changes in MVPA, as a result of the 4 components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent i n other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality.
Aim 3: To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal-setting) and moderators (i.e., age, time since diagnosis) of the four intervention components on MVPA.
Research participants will be identified and recruited at Robert H. Lurie Cancer Center (RHLCC) at Northwestern University (NU). All BCS and Buddies will complete an initial 10-15 minute eligibility screening online, over the phone, or in-person. The study RA will obtain informed consent and HIPAA authorization from eligible participants according to IRB approved procedures.
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
- None
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, age 18 years or older
- •Stage I-III breast cancer diagnosis within the past 5 years
- •Diagnosis of cancer between 18-39 years and within the past 5 years
- •≥3 months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
- •Self-report engagement in <60 min/week of MVPA
- •Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willingness to obtain medical clearance from a primary care physician or oncologist
- •Internet access and smartphone ownership
- •Fluency in spoken and written English
- •Willingness to find a buddy (someone who knows about their cancer and participation in this study and who is willing to participate by supporting them during the 24-week study), if assigned to that condition
- •For "Buddies"
- •Friend, co-worker, caregiver or family member of a participating BCS
- •Age 18 years or older
- •Score of 0 on all positive statement(s) of the Physical Activity Readiness Questionnaire (PAR-Q)18 or willing to obtain medical clearance from a primary care physician
- •Internet access and smartphone ownership
- •Fluency in spoken and written English
- •Willingness to share their Fitbit data with the study team
排除标准
- •Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic conditions), metastatic disease, or planned elective surgery
- •Currently pregnant or plans to become pregnant
- •Plans to move out of the United States in next 18 months
- •Current enrollment in another dietary or physical activity trial
- •Inability to provide informed consent
- •Prisoners or other detained individuals
研究组 & 干预措施
Exp Condition 10
Research participant receives the Core Intervention + General Mindfulness Training
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: E-Coach (Behavioral)
Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
干预措施: E-Coach (Behavioral)
Exp Condition 9
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 1
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 2
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 2
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 2
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: E-Coach (Behavioral)
Exp Condition 2
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 3
Research participant receives the Core Intervention + E-Coach + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 3
Research participant receives the Core Intervention + E-Coach + Buddy
干预措施: E-Coach (Behavioral)
Exp Condition 3
Research participant receives the Core Intervention + E-Coach + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 4
Research participant receives the Core Intervention + E-Coach
干预措施: Core Intervention (Behavioral)
Exp Condition 4
Research participant receives the Core Intervention + E-Coach
干预措施: E-Coach (Behavioral)
Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 6
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 6
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
干预措施: E-Coach (Behavioral)
Exp Condition 6
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 7
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 7
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
干预措施: E-Coach (Behavioral)
Exp Condition 7
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 7
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training + Buddy
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 8
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 8
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
干预措施: E-Coach (Behavioral)
Exp Condition 8
Research participant receives the Core Intervention + E-Coach + MVPA Specific Mindfulness Training
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 9
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 9
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 10
Research participant receives the Core Intervention + General Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 11
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 11
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 11
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training + Buddy
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 12
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 12
Research participant receives the Core Intervention + MVPA Specific Mindfulness Training
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 14
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: Core Intervention (Behavioral)
Exp Condition 14
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: General Mindfulness Training (Behavioral)
Exp Condition 14
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: MVPA-Specific Mindfulness Training (Behavioral)
Exp Condition 15
Research participant receives the Core Intervention + Buddy
干预措施: Core Intervention (Behavioral)
Exp Condition 15
Research participant receives the Core Intervention + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 16
Research participant receives the Core Intervention
干预措施: Core Intervention (Behavioral)
结局指标
主要结局
Change in Objective Physical Activity during the 48 week technology supported physical activity interventions in breast cancer survivors
时间窗: 48 weeks
Physical activity will be measured at baseline, 24 and 48 weeks.The ActiGraph accelerometer will be used. At each time point, participants will wear the device for 7 consecutive days during all waking hours, except when bathing or swimming. Each valid minute of wear time will be classified according to intensity (counts/min) using commonly accepted cut-points: sedentary (\<100), light activity (100-2019) and moderate/vigorous physical activity (≥2020). Minutes of moderate and vigorous physical activity will be used to assess change.
次要结局
- Leisure Time Physical Activity in breast cancer survivors(48 weeks)
- Anxiety in breast cancer survivors(48 weeks)
- Depression in breast cancer survivors(48 weeks)
- Fatigue in breast cancer survivors(48 weeks)
- Physical Function in breast cancer survivors(48 weeks)
- Sleep Disturbance in breast cancer survivors(48 weeks)
- Sleep Impairment in breast cancer survivors(48 weeks)
- Applied Cognition Abilities in breast cancer survivors(48 weeks)
- Light Intensity Physical Activity(48 weeks)
- Sedentary Time(48 weeks)
- Sleep Duration(48 weeks)
- Anxiety in breast cancer survivors(48 weeks)
- Depression in breast cancer survivors(48 weeks)
- Fatigue in breast cancer survivors(48 weeks)
- Physical Function in breast cancer survivors(48 weeks)
- Sleep Disturbance in breast cancer survivors(48 weeks)
- Sleep Impairment in breast cancer survivors(48 weeks)
- Applied Cognition Abilities in breast cancer survivors(48 weeks)
- Emotional Support in breast cancer survivors(48 weeks)
- Self-Esteem in breast cancer survivors(48 weeks)
- Social support for exercise in breast cancer survivors(48 weeks)
- Physical self-perception in breast cancer survivors(48 weeks)
- Post-traumatic growth in breast cancer survivors(48 weeks)
- Implementation feasibility measured by enrollment rate(48 weeks)
- Implementation feasibility measured by retention rate(48 weeks)
- Adherence to the study app + Fitbit by breast cancer survivors(48 weeks)
- Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey(48 weeks)
- Enjoyment of Physical Activity in young adult cancer survivors(48 weeks)
- Leisure Time Physical Activity in breast cancer survivors(48 weeks)
- Confidence in ability to be regularly active despite common barriers in breast cancer survivors(48 weeks)
- Exercise goal setting in breast cancer survivors(48 weeks)
- Confidence in ability to be regularly active in breast cancer survivors(48 weeks)
- Sitting time in breast cancer survivors(48 weeks)
- Outcome expectations for exercise in breast cancer survivors(48 weeks)
- Mindful Awareness in breast cancer survivors(48 weeks)
- Mindful self-compassion in breast cancer survivors(48 weeks)
- Change in body mass index in breast cancer survivors(48 weeks)
- Change in health behaviors in breast cancer survivors(48 weeks)
研究者
Siobhan M Phillips
Principal Investigator
Northwestern University