Tango for Neuropathy Among Breast Cancer Survivors
- Conditions
- Cancer, BreastNeuropathy
- Interventions
- Behavioral: Evidence-Based ExerciseBehavioral: Rhythmic Auditory Stimulation
- Registration Number
- NCT05114005
- 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.
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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.
- 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);
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Home Exercise (HEX) Evidence-Based Exercise 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 Tango Rhythmic Auditory Stimulation 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.
- Primary Outcome Measures
Name Time Method Postural Control (variability) 8 weeks root-mean square of the center of pressure (COP)
- Secondary Outcome Measures
Name Time Method 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
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 6 months post-intervention the number of falls or near falls experienced by the participant in the 6 months post-intervention
Postural Control (complexity) 1 month follow up post-intervention sample entropy of COP
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 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 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).
Trial Locations
- Locations (1)
Stephanie Spielman Comprehensive Breast Center
🇺🇸Columbus, Ohio, United States