Tango for Neuropathy Among Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Novel Interventions for Chemotherapy-Induced Neuropathy

Conditions
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Cancer, Breast, Neuropathy

Intervention / Treatment
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* Behavioral: Rhythmic Auditory Stimulation
* Behavioral: Evidence-Based Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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);

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tango<br>The intervention will consist of 16 Argentine Tango (Tango) sessions, adapted for neurorehabilitation per Hackney and Earhart (2010). Delivered over 8 weeks at a frequency of 2x per week and duration of 1 hour per session, this program teaches the basics steps of partnered Tango dance. | Behavioral: Rhythmic Auditory Stimulation<br>* Rhythmically-entrained sensorimotor activity.<br>|
| Active Comparator: Home Exercise (HEX)<br>The control group will consist of an evidence-based, structured home exercise program (HEX) based on the 8 week intervention described by Zimmer et al (2018) and recommended by physical therapists specializing in BC within our organization. This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week | Behavioral: Evidence-Based Exercise<br>* This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hr training (i.e., endurance, resistance, and sensorimotor) performed 2x per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Control (variability) | root-mean square of the center of pressure (COP) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Control (ellipse area) | 95% ellipse area of the COP | 8 weeks | 
| Postural Control (velocity) | velocity of COP | 8 weeks | 
| Postural Control (complexity) | sample entropy of COP | 8 weeks | 
| Postural Control (variability) | root-mean square of the center of pressure (COP) | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Postural Control (variability) | root-mean square of the center of pressure (COP) | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Postural Control (ellipse area) | 95% ellipse area of the COP | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Postural Control (ellipse area) | 95% ellipse area of the COP | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Postural Control (velocity) | velocity of COP | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Postural Control (velocity) | velocity of COP | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Postural Control (complexity) | sample entropy of COP | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Postural Control (complexity) | sample entropy of COP | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Postural Control (variability) | root-mean square of the center of pressure (COP) | 1 month follow up post-intervention | 
| Postural Control (ellipse area) | 95% ellipse area of the COP | 1 month follow up post-intervention | 
| Postural Control (velocity) | velocity of COP | 1 month follow up post-intervention | 
| Postural Control (complexity) | sample entropy of COP | 1 month follow up post-intervention | 
| Clinical measure of balance function | The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance. | 8 weeks | 
| Clinical measure of balance function | The Timed Up-and-Go test, or TUG, (<2 min to administer) is a timed test of a person's ability to stand from a chair, walk 10 feet, turn around, and return to sitting with shorter times indicating better functional balance. | 1 month follow-up post-intervention | 
| Neuropathy Symptoms Score | European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves. | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Neuropathy Symptoms Score | European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves. | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Neuropathy Symptoms Score | European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves. | 8 weeks | 
| Neuropathy Symptoms Score | European Organization for Research and Treatment of Cancer's Quality of Life Questionnaire, Chemotherapy-Induced Peripheral Neuropathy (CIPN 20): is a validated instrument for longitudinal evaluation of neuropathy symptoms induced by chemotherapy. This is a 20-item patient reported questionnaire that includes three subscales evaluating sensory, motor and autonomic symptoms. It is easy to use and filled out by patients themselves. | 1 month follow-up post-intervention | 
| Brief Pain Inventory Short Form | The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity right now using a single item visual analog scale (VAS) on which participants will rate how much pain they are in right now on a scale of 1 to 10 (10 being high the worst pain imaginable). | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Brief Pain Inventory Short Form | The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity right now using a single item visual analog scale (VAS) on which participants will rate how much pain they are in right now on a scale of 1 to 10 (10 being high the worst pain imaginable). | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Brief Pain Inventory Short Form | The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity right now using a single item visual analog scale (VAS) on which participants will rate how much pain they are in right now on a scale of 1 to 10 (10 being high the worst pain imaginable). | 8 weeks | 
| Brief Pain Inventory Short Form | The Brief Pain Inventory Short Form (BPI) is a validated instrument used to evaluate pain symptoms and functional capacity right now using a single item visual analog scale (VAS) on which participants will rate how much pain they are in right now on a scale of 1 to 10 (10 being high the worst pain imaginable). | 1 month follow-up post-intervention | 
| Cancer-Related Fatigue | The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue right now using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel right now on a scale of 1 to 10 (10 being high the worst fatigue imaginable). | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Cancer-Related Fatigue | The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue right now using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel right now on a scale of 1 to 10 (10 being high the worst fatigue imaginable). | at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions | 
| Cancer-Related Fatigue | The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue right now using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel right now on a scale of 1 to 10 (10 being high the worst fatigue imaginable). | 8 weeks | 
| Cancer-Related Fatigue | The Brief Fatigue Inventory (BFI) is used to rapidly assess the severity and impact of cancer-related fatigue right now using a single item visual analog scale (VAS) on which participants will rate how much fatigue they feel right now on a scale of 1 to 10 (10 being high the worst fatigue imaginable). | 1 month follow-up post-intervention | 
| Falls Incidence | the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study | once at the point of study enrollment | 
| Falls Incidence | the number of falls or near falls experienced by the participant since last evaluation/intervention session | at the beginning of each assessment or intervention session for up to 20 sessions | 
| Falls Incidence | the number of falls or near falls experienced by the participant in the 6 months post-intervention | 6 months post-intervention |