DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Patient-Reported Outcome (PRO) - CIN sensation
研究概览
简要总结
Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.
详细描述
This study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered Adapted Argentine Tango (Tango). This project will expand the investigators' pilot work (R21-AG068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of BC survivors suffering from chronic chemotherapy-induced sensorimotor deficits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease
- •completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago)
- •symptomatic for chemotherapy-induced neuropathy (self-report)
- •postural control score that indicates potential fall-risk
- •able to understand and comply with directions associated with testing and study treatments
排除标准
- •pre-existing vestibular dysfunction
- •poorly controlled diabetes (hgA1C>=8)
- •non-ambulatory (assistive and prosthetic devices allowed)
- •hearing impairment resulting in less than 10% hearing bilaterally
- •contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases)
- •currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.
结局指标
主要结局
Patient-Reported Outcome (PRO) - CIN sensation
时间窗: 4 weeks
Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling)
Dual-task function
时间窗: 4 weeks
Ability to move and think at the same time as measured by time to complete the Timed-Up-and-Go (TUG) test with concurrent cognitive task (i.e., counting backward by some number while completing a defined movement task)
次要结局
- Gait stability(4 weeks; 8 weeks)
- Patient-Reported Outcome (PRO) - hot/cold sensation(4 weeks; 8 weeks; 12 weeks)
- EORTC-CIPN 20(mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention)
- Falls(4 weeks; 8 weeks; 12 weeks; 6 months following intervention end)
- Brief Fatigue Inventory(4 weeks; 8 weeks; 12 weeks)
- Brief Pain Inventory(4 weeks; 8 weeks; 12 weeks)
- Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(4 weeks; 8 weeks; 12 weeks)
- Physical Health Questionnaire-2 (PHQ-2)(4 weeks; 8 weeks; 12 weeks)
- Generalized Anxiety Questionnaire(4 weeks; 8 weeks; 12 weeks)
- The Mini Balance Evaluation Systems Test (MiniBEST)(4 weeks (Control group); 8 weeks (Intervention group))
- Biomechanical measures of postural control(4 weeks; 8 weeks; 12 weeks)
- Upper Extremity Function(4 weeks; 8 weeks; 12 weeks)
- Six minute walk test (6mwt)(4 weeks; 8 weeks)
研究者
Lise Worthen-Chaudhari
Principal Investigator
Ohio State University Comprehensive Cancer Center