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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
Rhythmically-entrained sensorimotor activity.
This program consists of information on neuropathy and fall prevention combined with a schedule of 1 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week
Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States
Postural Control (Variability)
root-mean square of the center of pressure (COP)
Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Intrinsic Motivation
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.
Time frame: Assessed at week 4, week 8, and week 12
Postural Control (Ellipse Area)
95% ellipse area of the COP
Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Velocity)
velocity of COP
Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Complexity)
sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural response
Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Postural Control (Variability) at Tango Sessions
root-mean square of the center of pressure (COP). The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Time frame: 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
95% ellipse area of the COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Time frame: 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
velocity of COP. The mean will be taken of all beginning of session data points together and all end of session data points together. Lower numbers indicate better neuromotor health.
Time frame: 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
sample entropy of the center of pressure (COP). Sample entropy is a non-linear COP measure that determines the irregularity of a time-series. Sample entropy of the resultant COP position will be calculated using the increment calculation method (SEI) with constant values applied of m = 3 and r = 0.3. Entropy of postural responses represents the automatic complexity of neuromotor control that is available to an individual. Sample entropy scores won't go below 0 or above 2, and higher values indicate better complexity in postural responseThe mean will be taken of all beginning of session data points together and all end of session data points together
Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 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.
Time frame: At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks
Neuropathy Symptoms Score at Tango 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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity. The mean will be taken of all beginning of session data points together and all end of session data points together
Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 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. It is easy to use and filled out by patients themselves. Scores range between 1 to 10 with higher scores indicating greater chemotherapy-induced peripheral neuropathy (CIPN) severity.
Time frame: At week 8 of intervention and at 4-week follow-up post intervention
Brief Pain Inventory Short Form at Tango 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). The mean will be taken of all beginning of session data points together and all end of session data points together
Time frame: 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
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).
Time frame: At week 8 of intervention and at 4-week follow-up post intervention
Cancer-Related Fatigue (BFI Scores) at Tango 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). The mean will be taken of all beginning of session data points together and all end of session data points together
Time frame: at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 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).
Time frame: At week 8 and at 4-week follow-up visit post intervention
Number of Falls
the number of falls or near falls that the participant remembers experiencing in the month prior to enrollment in the study will be assessed. All reported falls will be totaled and reported by arm.
Time frame: once at the point of study enrollment
Number of Falls
the number of falls or near falls experienced by the participant since last evaluation/intervention session. All reported falls throughout the intervention time period will be totaled and reported by arm.
Time frame: at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks
Number of Falls
the number of falls or near falls experienced by the participant in the 6 months post-intervention. All reported falls throughout the follow-up time period will be totaled and reported by arm
Time frame: 6 months post-intervention
Change in Dual-task Function
Dual task function was measured using the Timed-Up-and-Go motor task while counting backward by 3 s (TUGCog), a validated clinical test of dual-task function for which lower values indicate better performance. To perform this test, participants completed the Timed-Up-and Go (TUG) test commonly used in clinical practice wherein individuals stand from a chair with arms, walk 3 meters, turn around, and return to sitting as fast as safely possible (i.e. motor task) while counting out loud and backward by 3 s (i.e. cognitive task). The test is completed 3 times, with rest allowed between trials. Time in seconds per trial is averaged to produce the TUGCog score per timepoint.
Time frame: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
Adherence
Adherence is measured by the number of enrollees who participated through each time point of the study
Time frame: Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks
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