Optimization of a mHealth Physical Activity Promotion Intervention With Mindful Awareness for Adolescent and Young Adult 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
- 2
- 主要终点
- Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
研究概览
简要总结
The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.
PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks
SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality
THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) of the four intervention components on MVPA.
详细描述
The purpose of the present study is to utilize Multiphase Optimization Strategy (MOST)1 to test four social support and mindfulness components (e-coaching, buddy, general mindfulness training, and MVPA-specific mindfulness training) in a 12-week mHealth moderate to vigorous intensity physical activity (MVPA) intervention in a sample of young adult cancer survivors (YACS), to improve quality of life (QOL) and decrease adverse effects and symptom burden.
PRIMARY AIM To identify which components from four mHealth components under consideration for inclusion meaningfully contribute to improvements in MVPA at 12 and 24 weeks
SECONDARY AIM To examine how changes in MVPA, as a result of Opt2Move components, may influence additional health behaviors and outcomes including: a) symptom burden (i.e. fatigue, depression, anxiety); b) time spent in other activity intensities (i.e. light, sedentary time); and c) sleep duration and quality
THIRD AIM To examine potential mediators (i.e. adherence, psychosocial factors such as post-traumatic growth, self-compassion, self-efficacy, and goal setting) and moderators (cancer type, age, gender) 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) and at the Wake Forest Baptist Comprehensive Cancer Center (WFBCCC) at Wake Forest University (WFU). All YACS 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. After consent is received, all additional study procedures (i.e. assessments, orientation, intervention delivery, etc.) will be handled by the coordinating center (NU) to ensure all procedures are implemented consistently and improve efficiency.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of nonmetastatic cancer (except non-melanoma skin cancer) within 5 years from the time of screening / study overview session
- •Age Diagnosis of cancer between 18-39 years at time of diagnosis and at time of screening / study overview session
- •Three or more months post-completion of primary treatment (i.e., surgery, chemotherapy, and/or radiation); may still be undergoing endocrine or hormone therapies
- •Score of 0 on two of the Exercise Preparticipation Health Screening Questionnaire items or willingness to obtain medical clearance from a primary care physician or oncologist
- •Self-report engagement in <60 minutes total each week of MVPA at time of screening / study overview session
- •Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
- •Internet access
- •Fluency in spoken and written English
- •Willingness, at time of screening / study overview session, 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 6-month study), if assigned to that condition
- •For "Buddies"
- •Friend, co-worker, caregiver or family member of a participating YACS
- •Age 18 years or older
- •Score of 0 on the Exercise Preparticipation Health Screening Questionnaire or willingness to obtain medical clearance from a primary care physician
- •Ownership of a smartphone that is either an iPhone (version 5 or greater) or an Android (version 5.0 or greater)
- •Internet access
- •Fluency in spoken and written English
- •Willingness to share their Fitbit data with the study team
排除标准
- •For YACS: Diagnosis of non-melanoma skin cancer
- •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 in the next 12 months
- •Plans to move out of the United States in next 18 months
- •For YACS: 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 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: Core Intervention (Behavioral)
Exp Condition 3
Research participant receives the Core Intervention + E-Coach + 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 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 9
Research participant receives the Core Intervention + General Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 10
Research participant receives the Core Intervention + General Mindfulness Training
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: 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 13
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training + Buddy
干预措施: Buddy (Behavioral)
Exp Condition 15
Research participant receives the Core Intervention + 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: E-Coach (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: Buddy (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 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 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: 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: General Mindfulness Training (Behavioral)
Exp Condition 5
Research participant receives the Core Intervention + E-Coach + General Mindfulness Training + Buddy
干预措施: Buddy (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 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: MVPA-Specific Mindfulness Training (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 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 11
Research participant receives the Core Intervention + MVPA Specific 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: Core Intervention (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: 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 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: MVPA-Specific Mindfulness Training (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)
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 14
Research participant receives the Core Intervention + General Mindfulness Training + MVPA Specific Mindfulness Training
干预措施: General Mindfulness Training (Behavioral)
结局指标
主要结局
Physical Activity before and after the 12-week technology supported physical activity interventions in young adult cancer survivors
时间窗: 24 weeks
Physical activity will be measured at baseline and at 12 and 24 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).
次要结局
- Physical Function in young adult cancer survivors(24 weeks)
- Anxiety in young adult cancer survivors(24 weeks)
- Depression in young adult cancer survivors(24 weeks)
- Fatigue in young adult cancer survivors(24 weeks)
- Sleep Disturbance in young adult cancer survivors(24 weeks)
- Sleep Impairment in young adult cancer survivors(24 weeks)
- Ability to participate in social roles and activities in young adult cancer survivors(24 weeks)
- Applied Cognition Abilities in young adult cancer survivors(24 weeks)
- Pain interference in young adult cancer survivors(24 weeks)
- Pain intensity in young adult cancer survivors(24 weeks)
- Leisure Time Physical Activity in young adult cancer survivors(24 weeks)
- Light Intensity Physical Activity(24 weeks)
- Sedentary Time(24 weeks)
- Sleep Duration(24 weeks)
- Mindful presence in young adult cancer survivors(24 weeks)
- Meditation experience in young adult cancer survivors(baseline)
- Change in health behaviors in young adult cancer survivors(24 weeks)
- Change in treatment expectations in young adult cancer survivors(24 weeks)
- Change in life event related stress in young adult cancer survivors(24 weeks)
- Environmental factors in physical activity participation in young adult cancer survivors(24 weeks)
- Meditation practice in young adult cancer survivors(24 weeks)
- Implementation feasibility measured by enrollment rate(24 weeks)
- Implementation feasibility measured by retention rate(24 weeks)
- Adherence to the OPT2MOVE app + Fitbit by young adult cancer survivors(24 weeks)
- Acceptability of the technology supported physical activity interventions as measured by a post-intervention evaluation survey(24 weeks)
- Physical Function in young adult cancer survivors(24 weeks)
- Sleep Impairment in young adult cancer survivors(24 weeks)
- Confidence in ability to be regularly active in young adult cancer survivors(24 weeks)
- Confidence in ability to be regularly active despite common barriers in young adult cancer survivors(24 weeks)
- Anxiety in young adult cancer survivors(24 weeks)
- Depression in young adult cancer survivors(24 weeks)
- Pain intensity in young adult cancer survivors(24 weeks)
- Physical self-perception in young adult cancer survivors(24 weeks)
- Fatigue in young adult cancer survivors(24 weeks)
- Applied Cognition Abilities in young adult cancer survivors(24 weeks)
- Pain interference in young adult cancer survivors(24 weeks)
- Sleep Disturbance in young adult cancer survivors(24 weeks)
- Ability to participate in social roles and activities in young adult cancer survivors(24 weeks)
- Leisure Time Physical Activity in young adult cancer survivors(24 weeks)
- Sitting time in young adult cancer survivors(24 weeks)
- Outcome expectations for exercise in young adult cancer survivors(24 weeks)
- Self-Esteem in young adult cancer survivors(24 weeks)
- Emotional Support in young adult cancer survivors(24 weeks)
- Social support for exercise in young adult cancer survivors(24 weeks)
- Change in body mass index in young adult cancer survivors(24 weeks)
- Mindful Awareness in young adult cancer survivors(24 weeks)
- Mindful acceptance in young adult cancer survivors(24 weeks)
- Mindful self-kindness in young adult cancer survivors(24 weeks)
- Mindful de-centering in young adult cancer survivors(24 weeks)
- Change in key components of multi-purpose action control framework in young adult cancer survivors(24 weeks)
- Change in executive function in young adult cancer survivors(24 weeks)
研究者
Siobhan M Phillips
Principal Investigator
Northwestern University