Multicenter Pilot Study: Leveraging Digital Health to Promote Evidence-Based Physical Activity to Improve Symptoms Among Patients Undergoing Radiation for Breast Cancer (PRO-ACTIVE)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Proportion of eligible patients that consent to the screening registry (Feasibility)
研究概览
简要总结
This clinical trial evaluates a digital health intervention for improving symptoms and physical activity among patients with breast cancer undergoing radiation. Cancer-related fatigue is common and strongly associated with quality of life during and after treatment. Increasing emphasis on early symptom detection and management has prompted initiatives to collect patient-reported fatigue from all patients during treatment. Mind-body interventions including physical activity and yoga are recommendations to treat fatigue and comorbid (coexisting) symptoms. Lower socioeconomic status has not only been associated with higher rates of physical inactivity but also with perceptions that it could negatively impact fatigue and quality of life during treatment. A virtual mind-body program called Integrative Medicine at Home (IM@Home) includes cardio fitness and yoga classes in a bundled intervention that has demonstrated decreased fatigue, depression, insomnia, and symptom distress among patients undergoing breast radiation. The IM@Home program may also increase physical activity among patients with breast cancer undergoing radiation.
详细描述
OUTLINE:
REGISTRY: Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.
INTERVENTION: Patients participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •Ability to understand English, or has a caregiver who understands English.
- •Ability to understand and willingness to sign a written informed consent document, virtually or in-person.
- •Current breast cancer diagnosis.
- •Currently receiving radiation with curative intent (including partial breast, whole breast, or regional nodal radiation).
排除标准
- •Patients who are non-English speaking that would prevent their participation in IM@Home.
研究组 & 干预措施
Registry (FitBit, PRO surveys)
Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.
干预措施: Questionnaire Administration (Other)
Intervention (IM@Home program)
A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.
干预措施: IM@Home Program (Behavioral)
Intervention (IM@Home program)
A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.
干预措施: Medical Device Usage and Evaluation (Other)
Intervention (IM@Home program)
A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.
干预措施: Questionnaire Administration (Other)
Intervention (IM@Home program)
A subset of patients in the registry will participate in the IM@Home program consisting of 20+ live, virtual mind-body and fitness classes ranging from yoga and tai chi to dance cardio, guided meditation, and music therapy delivered via Zoom over 30-60 minutes. Patients are instructed to complete at least 3 classes per week for 12 weeks.
干预措施: Interview (Other)
Registry (FitBit, PRO surveys)
Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.
干预措施: Interview (Other)
Registry (FitBit, PRO surveys)
Patients receive a FitBit activity tracker and complete patient-reported outcomes (PRO) surveys every 2 weeks (Q2W) to monitor fatigue, comorbid symptoms, and physical activity during and immediately after radiation therapy. Patients with presence of self-reported symptoms or physical inactivity at baseline and/or from any Q2W PRO surveys are then invited to participate and register for IM@Home.
干预措施: Medical Device Usage and Evaluation (Other)
结局指标
主要结局
Proportion of eligible patients that consent to the screening registry (Feasibility)
时间窗: Up to 6 months
Will be considered feasible, as designed, if over 50% of eligible patients consent to the screening registry. Will be determined using descriptive statistics.
Proportion of patients with fatigue or other comorbid symptoms enrolling to the Integrative Medicine at Home (IM@Home) virtual intervention (Acceptability)
时间窗: Up to 6 months
Will be considered acceptable if 50% of patients reporting fatigue or other comorbid symptoms agree to enroll to the IM@Home intervention. Will be determined using descriptive statistics.
Proportion of patients enrolling in IM@Home virtual intervention that report favorable implementation outcomes (Appropriateness)
时间窗: At 12 weeks
Will be assessed using a validated patient-reported outcomes (PRO) scale with responses as agree or completely agree. Will be determined using descriptive statistics.
次要结局
- Proportion of participants meeting guideline recommendations for physical activity(At baseline, 2, 4, 6, 8, 10, and 12 weeks)
- Relationship between self-reported and monitor-based physical activity(At baseline, 2, 4, 6, 8, 10, and 12 weeks)
- Patient-reported fatigue(At baseline, 2, 4, 6, 8, 10, and 12 weeks)
- Sleep quality(At baseline, 4, 8, and 12 weeks)
- Social isolation(At baseline, 6, and 12 weeks)