Tango for Neuropathy Among Breast Cancer Survivors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tango 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
Rhythmically-entrained sensorimotor activity.
|
| Active Comparator: Home Exercise (HEX) 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
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
|
Outcome Measures
Primary Outcome Measures
- Postural Control (variability) [8 weeks]
root-mean square of the center of pressure (COP)
Secondary Outcome Measures
- Postural Control (ellipse area) [8 weeks]
95% ellipse area of the COP
- Postural Control (velocity) [8 weeks]
velocity of COP
- Postural Control (complexity) [8 weeks]
sample entropy of COP
- Postural Control (variability) [at the beginning of each assessment or intervention session for up to 20 sessions]
root-mean square of the center of pressure (COP)
- Postural Control (variability) [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
root-mean square of the center of pressure (COP)
- Postural Control (ellipse area) [at the beginning of each assessment or intervention session for up to 20 sessions]
95% ellipse area of the COP
- Postural Control (ellipse area) [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
95% ellipse area of the COP
- Postural Control (velocity) [at the beginning of each assessment or intervention session for up to 20 sessions]
velocity of COP
- Postural Control (velocity) [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
velocity of COP
- Postural Control (complexity) [at the beginning of each assessment or intervention session for up to 20 sessions]
sample entropy of COP
- Postural Control (complexity) [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
sample entropy of COP
- Postural Control (variability) [1 month follow up post-intervention]
root-mean square of the center of pressure (COP)
- Postural Control (ellipse area) [1 month follow up post-intervention]
95% ellipse area of the COP
- Postural Control (velocity) [1 month follow up post-intervention]
velocity of COP
- Postural Control (complexity) [1 month follow up post-intervention]
sample entropy of COP
- Clinical measure of balance function [8 weeks]
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.
- Clinical measure of balance function [1 month follow-up post-intervention]
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.
- Neuropathy Symptoms Score [at the beginning of each assessment or intervention session for up to 20 sessions]
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.
- Neuropathy Symptoms Score [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
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.
- Neuropathy Symptoms Score [8 weeks]
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.
- Neuropathy Symptoms Score [1 month follow-up post-intervention]
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.
- Brief Pain Inventory Short Form [at the beginning of each assessment or intervention session for up to 20 sessions]
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).
- Brief Pain Inventory Short Form [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
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).
- Brief Pain Inventory Short Form [8 weeks]
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).
- Brief Pain Inventory Short Form [1 month follow-up post-intervention]
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).
- Cancer-Related Fatigue [at the beginning of each assessment or intervention session for up to 20 sessions]
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).
- Cancer-Related Fatigue [at the conclusion of each assessment or intervention session (up to 1 hr duration) for up to 20 sessions]
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).
- Cancer-Related Fatigue [8 weeks]
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).
- Cancer-Related Fatigue [1 month follow-up post-intervention]
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).
- Falls Incidence [once at the point of study enrollment]
the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study
- Falls Incidence [at the beginning of each assessment or intervention session for up to 20 sessions]
the number of falls or near falls experienced by the participant since last evaluation/intervention session
- Falls Incidence [6 months post-intervention]
the number of falls or near falls experienced by the participant in the 6 months post-intervention
Other Outcome Measures
- Quantified Clinical Measure of Balance Function [8 weeks]
The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures
- Quantified Clinical Measure of Balance Function [1 month follow-up post-intervention]
The Mini Balance Evaluation System Test short version (MiniBEST): evaluates sensory organization, anticipatory and reactive postural control, and dynamic gait indices on a scale from 1 to 28 points (28 represents the highest function measurable by the test); was recently recommended for use in studies of neuropathy; and discriminated BC survivors from controls in at least 1 prior study. Instrumentation of MiniBEST will enable the calculation of spatiotemporal, kinematic, and co-contraction measures.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Breast cancer survivor stage I-III
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Symptomatic for neuropathy
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postural control outside 70% CI for adults who are middle-aged without neurotrauma
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having completed taxane-based chemotherapy treatment at least 3 months ago;
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able to understand and comply with directions associated with testing and study treatments.
Exclusion Criteria:
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Pre-existing vestibular deficit;
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poorly controlled diabetes (hgA1C > 8);
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non-ambulatory or lower extremity amputation (assistive devices allowed);
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use of cytotoxic or immunotherapy during study (endocrine therapy allowed);
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participation in physical therapy during the study;
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contraindication to participate in Tango due to orthopedic issue (e.g., herniated vertebral disc);
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stephanie Spielman Comprehensive Breast Center | Columbus | Ohio | United States | 43212 |
Sponsors and Collaborators
- Ohio State University Comprehensive Cancer Center
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Lise Worthen-Chaudhari, PhD, MFA, Ohio State University Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
- Hackney ME, Earhart GM. Recommendations for Implementing Tango Classes for Persons with Parkinson Disease. Am J Dance Ther. 2010 Jun;32(1):41-52. doi: 10.1007/s10465-010-9086-y.
- Zimmer P, Trebing S, Timmers-Trebing U, Schenk A, Paust R, Bloch W, Rudolph R, Streckmann F, Baumann FT. Eight-week, multimodal exercise counteracts a progress of chemotherapy-induced peripheral neuropathy and improves balance and strength in metastasized colorectal cancer patients: a randomized controlled trial. Support Care Cancer. 2018 Feb;26(2):615-624. doi: 10.1007/s00520-017-3875-5. Epub 2017 Sep 30.
- 2015C0090
- NCI-2018-00310
- R21AG068831
- OSU-15047