Dance-Based Avenues to Advance Nonpharmacologic Treatment of Chemotherapy Effects (DAANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Postural Control (Variability)
研究概览
简要总结
Group dance classes have been found to improve markers of quality of life and physical health (i.e., balance) among some populations engaged in rehabilitation, such as the elderly and individuals with Parkinson Disease. However, such interventions have yet to be studied among cancer survivors despite the relevance of quality of life and physical health within cancer survivorship. Group dance classes are a promising avenue in that they deliver activity-based medicine in a social context, thus potentially improving physical as well as psychosocial aspects of health. To further this avenue of inquiry, we propose to study the effect of dance-based interventions for cancer survivors.
详细描述
Participants will be randomized (1:1) to one of two activity intervention arms: Argentine Tango dance or home exercise. Information about neuropathy symptoms, motion, falls incidence, and participant feedback about the interventions will be collected.
Aim1: To evaluate change in postural control over 16 sessions of Tango (exp) vs HEX (control) (n=26 per group) as primary endpoint. As secondary measures, to assess: balance function (i.e., TUG) and patient-reported outcomes (PROs) (i.e., symptoms, pain, fatigue, mood, quality of life) monthly including 1 month post-intervention completion; postural control and symptoms within-session; and falls incidence weekly for 6 months following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures sensitive to neuropathy disease state (i.e., sway variability and area).
Aim2: To evaluate change in gait variability after 16 sessions of Tango (exp) vs HEX (control) (n=26 per group; 1:1 randomization). As secondary measures, to analyze local and orbital dynamic stability (pre, post, and 1mo post-intervention), PROs (monthly), and falls incidence (weekly) following intervention completion. Hypothesis: At primary endpoint, participants in the experimental group will show more improvement than participants in the control group in measures of gait variability (i.e., stride-to-stride variability in speed).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 survivor stage I-III
- •Symptomatic for neuropathy
- •postural control outside 70% CI for adults who are middle-aged without neurotrauma
- •having completed taxane-based chemotherapy treatment at least 3 months ago;
- •able to understand and comply with directions associated with testing and study treatments.
排除标准
- •Pre-existing vestibular deficit;
- •poorly controlled diabetes (hgA1C > 8);
- •non-ambulatory or lower extremity amputation (assistive devices allowed);
- •use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
- •participation in physical therapy during the study;
- •contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);
结局指标
主要结局
Postural Control (Variability)
时间窗: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
root-mean square of the center of pressure (COP)
Intrinsic Motivation
时间窗: Assessed at week 4, week 8, and week 12
Intrinsic motivation will be measured using a subscale of the Intrinsic Motivation Inventory (IMI). The 6 item Interest/Enjoyment subscale of the IMI represents intrinsic motivation in an activity just performed as a possible score of 6 to 36 with 6 = most; 18 = neutral; 36 = least interesting/enjoyable. Specific items queried include whether the activity just performed was: enjoyable, enjoyed, boring (reverse order), interesting, fun, and able to hold the participant's attention.
次要结局
- Postural Control (Ellipse Area)(At baseline, week 8 of intervention, and at 4 week follow-up post intervention)
- Postural Control (Velocity)(At baseline, week 8 of intervention, and at 4 week follow-up post intervention)
- Postural Control (Complexity)(At baseline, week 8 of intervention, and at 4 week follow-up post intervention)
- Postural Control (Variability) at Tango Sessions(at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Postural Control (Ellipse Area) at Tango Sessions(at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Postural Control (Velocity) at Tango Sessions(at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Cancer-Related Fatigue (BFI Scores) at Tango Sessions(at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Postural Control (Complexity) at Tango Sessions(at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Change in Dual-task Function(Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks)
- Neuropathy Symptoms Score at Tango Sessions(at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Brief Pain Inventory Short Form(At week 8 of intervention and at 4-week follow-up post intervention)
- Clinical Measure of Balance Function(At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks)
- Neuropathy Symptoms Score(At week 8 of intervention and at 4-week follow-up post intervention)
- Brief Pain Inventory Short Form at Tango Sessions(at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks)
- Cancer-Related Fatigue(At week 8 and at 4-week follow-up visit post intervention)
- Number of Falls(6 months post-intervention)
- Adherence(Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks)
研究者
Lise Worthen-Chaudhari
Research Scientist
Ohio State University Comprehensive Cancer Center