Cancer, Breast, Neuropathy
Conditions
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).
Interventions
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
Sponsors
Study design
Eligibility
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);
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intrinsic Motivation | 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. |
| Postural Control (Variability) | At baseline, week 8 of intervention, and at 4 week follow-up post intervention | root-mean square of the center of pressure (COP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postural Control (Velocity) | At baseline, week 8 of intervention, and at 4 week follow-up post intervention | velocity of COP |
| Postural Control (Complexity) | At baseline, week 8 of intervention, and at 4 week follow-up post intervention | 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 |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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 |
| Clinical Measure of Balance Function | At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 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. |
| 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 | 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 |
| 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 | 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 |
| Brief Pain Inventory Short Form | At week 8 of intervention and at 4-week 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 (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 | 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 |
| Cancer-Related Fatigue | At week 8 and at 4-week follow-up visit 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). |
| Number of Falls | 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 will be assessed. All reported falls will be totaled and reported by arm. |
| Change in Dual-task Function | Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks | 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. |
| Adherence | Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks | Adherence is measured by the number of enrollees who participated through each time point of the study |
| Neuropathy Symptoms Score | At week 8 of intervention and at 4-week 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. 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. |
| Postural Control (Ellipse Area) | At baseline, week 8 of intervention, and at 4 week follow-up post intervention | 95% ellipse area of the COP |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Rhythmic Auditory Stimulation: Rhythmically-entrained sensorimotor activity. | 26 |
| 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
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 | 26 |
| Total | 52 |
Baseline characteristics
| Characteristic | Tango | Total | Home Exercise (HEX) |
|---|---|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 8.37 | 61.2 years STANDARD_DEVIATION 9.65 | 58.9 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 26 Participants | 52 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 48 Participants | 25 Participants |
| Region of Enrollment United States | 26 participants | 52 participants | 26 participants |
| Sex: Female, Male Female | 25 Participants | 51 Participants | 26 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 19 / 26 | 11 / 26 |
| serious Total, serious adverse events | 1 / 26 | 2 / 26 |
Outcome results
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
Population: The number of analyzed participants is the number of participants who were still adhering to the study intervention at the time points that intrinsic motivation data was collected
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tango | Intrinsic Motivation | 4 weeks | 6 score on a scale |
| Tango | Intrinsic Motivation | 8 weeks | 6 score on a scale |
| Tango | Intrinsic Motivation | 12 weeks | 6 score on a scale |
| Home Exercise (HEX) | Intrinsic Motivation | 4 weeks | 21.5 score on a scale |
| Home Exercise (HEX) | Intrinsic Motivation | 8 weeks | 18 score on a scale |
| Home Exercise (HEX) | Intrinsic Motivation | 12 weeks | 16 score on a scale |
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
Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Variability) | Baseline | 10.3 millimeters | Standard Deviation 4.93 |
| Tango | Postural Control (Variability) | Week 8 | 8.03 millimeters | Standard Deviation 3.54 |
| Tango | Postural Control (Variability) | Follow-up Visit (4 weeks post-intervention) | 7.74 millimeters | Standard Deviation 3.67 |
| Home Exercise (HEX) | Postural Control (Variability) | Baseline | 9.64 millimeters | Standard Deviation 2.42 |
| Home Exercise (HEX) | Postural Control (Variability) | Week 8 | 8.00 millimeters | Standard Deviation 2.82 |
| Home Exercise (HEX) | Postural Control (Variability) | Follow-up Visit (4 weeks post-intervention) | 8.61 millimeters | Standard Deviation 2.31 |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tango | Adherence | Attended Introductory Session | 23 participants |
| Tango | Adherence | Adhered through 8 weeks of intervention | 17 participants |
| Tango | Adherence | Adhered through 4 weeks of intervention | 20 participants |
| Tango | Adherence | Returned for follow-up 1 month post- intervention (12 week timepoint) | 17 participants |
| Tango | Adherence | Randomized | 26 participants |
| Home Exercise (HEX) | Adherence | Returned for follow-up 1 month post- intervention (12 week timepoint) | 8 participants |
| Home Exercise (HEX) | Adherence | Randomized | 26 participants |
| Home Exercise (HEX) | Adherence | Attended Introductory Session | 22 participants |
| Home Exercise (HEX) | Adherence | Adhered through 4 weeks of intervention | 13 participants |
| Home Exercise (HEX) | Adherence | Adhered through 8 weeks of intervention | 10 participants |
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
Population: The number of participants analyzed is the number of participants for which BPI scores were collected at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Brief Pain Inventory Short Form | Week 8 | 1.72 score on a scale | Standard Deviation 1.53 |
| Tango | Brief Pain Inventory Short Form | Follow-up (4 weeks post-intervention) | 1.78 score on a scale | Standard Deviation 1.83 |
| Home Exercise (HEX) | Brief Pain Inventory Short Form | Week 8 | 1.07 score on a scale | Standard Deviation 0.999 |
| Home Exercise (HEX) | Brief Pain Inventory Short Form | Follow-up (4 weeks post-intervention) | 1.55 score on a scale | Standard Deviation 1.99 |
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
Population: BPI scores at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Brief Pain Inventory Short Form at Tango Sessions | Beginning of sessions | 1.68 score on a scale | Standard Deviation 1.59 |
| Tango | Brief Pain Inventory Short Form at Tango Sessions | End of sessions | 1.20 score on a scale | Standard Deviation 1.28 |
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
Population: The number of participants analyzed is the number of participants for which BFI scores were collected at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Cancer-Related Fatigue | Week 8 | 8.13 score on a scale | Standard Deviation 8.95 |
| Tango | Cancer-Related Fatigue | Follow-up (4 weeks post intervention) | 7.22 score on a scale | Standard Deviation 8.72 |
| Home Exercise (HEX) | Cancer-Related Fatigue | Week 8 | 10.7 score on a scale | Standard Deviation 11.4 |
| Home Exercise (HEX) | Cancer-Related Fatigue | Follow-up (4 weeks post intervention) | 13.3 score on a scale | Standard Deviation 14.3 |
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
Population: BFI scores at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Cancer-Related Fatigue (BFI Scores) at Tango Sessions | Beginning of sessions | 8.56 score on a scale | Standard Deviation 9.61 |
| Tango | Cancer-Related Fatigue (BFI Scores) at Tango Sessions | End of sessions | 1.21 score on a scale | Standard Deviation 1.3 |
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tango | Change in Dual-task Function | Change between baseline to 4 weeks | -2.65 seconds |
| Tango | Change in Dual-task Function | Change between baseline and 8 weeks | -2.47 seconds |
| Tango | Change in Dual-task Function | Change between baseline and 12 weeks (follow-up visit) | -2.68 seconds |
| Home Exercise (HEX) | Change in Dual-task Function | Change between baseline to 4 weeks | -1.9 seconds |
| Home Exercise (HEX) | Change in Dual-task Function | Change between baseline and 8 weeks | -2.65 seconds |
| Home Exercise (HEX) | Change in Dual-task Function | Change between baseline and 12 weeks (follow-up visit) | -3.06 seconds |
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
Population: The number of participants analyzed represents the number who completed the TUG tests at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Clinical Measure of Balance Function | Baseline | 10.3 seconds | Standard Deviation 2.47 |
| Tango | Clinical Measure of Balance Function | Week 4 | 8.65 seconds | Standard Deviation 1.92 |
| Tango | Clinical Measure of Balance Function | Follow-up Visit (4 weeks post-intervention) | 8.49 seconds | Standard Deviation 1.79 |
| Home Exercise (HEX) | Clinical Measure of Balance Function | Baseline | 11.7 seconds | Standard Deviation 5.21 |
| Home Exercise (HEX) | Clinical Measure of Balance Function | Week 4 | 8.25 seconds | Standard Deviation 1.74 |
| Home Exercise (HEX) | Clinical Measure of Balance Function | Follow-up Visit (4 weeks post-intervention) | 7.70 seconds | Standard Deviation 1.25 |
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
Population: The number of participants analyzed is the number of participants for which neuropathy symptoms scores were collected at each time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Neuropathy Symptoms Score | Week 8 | 6.60 score on a scale | Standard Deviation 3.97 |
| Tango | Neuropathy Symptoms Score | Follow-up (4 weeks post-intervention) | 7.06 score on a scale | Standard Deviation 4.08 |
| Home Exercise (HEX) | Neuropathy Symptoms Score | Week 8 | 6.89 score on a scale | Standard Deviation 7.41 |
| Home Exercise (HEX) | Neuropathy Symptoms Score | Follow-up (4 weeks post-intervention) | 5.18 score on a scale | Standard Deviation 5.36 |
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
Population: Neuropathy symptoms scores at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Neuropathy Symptoms Score at Tango Sessions | Beginning of sessions | 6.68 score on a scale | Standard Deviation 4.25 |
| Tango | Neuropathy Symptoms Score at Tango Sessions | End of sessions | 3.29 score on a scale | Standard Deviation 3.01 |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tango | Number of Falls | 1 number of falls |
| Home Exercise (HEX) | Number of Falls | 0 number of falls |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tango | Number of Falls | 1 Number of falls |
| Home Exercise (HEX) | Number of Falls | 0 Number of falls |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tango | Number of Falls | 0 Number of falls |
| Home Exercise (HEX) | Number of Falls | 1 Number of falls |
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
Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Complexity) | Baseline | 0.480 sample entropy score | Standard Deviation 0.157 |
| Tango | Postural Control (Complexity) | Week 8 | 0.558 sample entropy score | Standard Deviation 0.161 |
| Tango | Postural Control (Complexity) | Follow-up Visit (4 weeks post-intervention) | 0.559 sample entropy score | Standard Deviation 0.121 |
| Home Exercise (HEX) | Postural Control (Complexity) | Baseline | 0.467 sample entropy score | Standard Deviation 0.12 |
| Home Exercise (HEX) | Postural Control (Complexity) | Week 8 | 0.566 sample entropy score | Standard Deviation 0.124 |
| Home Exercise (HEX) | Postural Control (Complexity) | Follow-up Visit (4 weeks post-intervention) | 0.559 sample entropy score | Standard Deviation 0.103 |
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
Population: Postural control at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Complexity) at Tango Sessions | Beginning of Sessions | 0.520 sample entropy score | Standard Deviation 0.145 |
| Tango | Postural Control (Complexity) at Tango Sessions | End of Sessions | 0.546 sample entropy score | Standard Deviation 0.18 |
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
Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Ellipse Area) | Baseline | 1023 millimeters squared | Standard Deviation 1052 |
| Tango | Postural Control (Ellipse Area) | Week 8 | 595 millimeters squared | Standard Deviation 618 |
| Tango | Postural Control (Ellipse Area) | Follow-up Visit (4 weeks post-intervention) | 570 millimeters squared | Standard Deviation 606 |
| Home Exercise (HEX) | Postural Control (Ellipse Area) | Baseline | 775 millimeters squared | Standard Deviation 441 |
| Home Exercise (HEX) | Postural Control (Ellipse Area) | Week 8 | 574 millimeters squared | Standard Deviation 389 |
| Home Exercise (HEX) | Postural Control (Ellipse Area) | Follow-up Visit (4 weeks post-intervention) | 647 millimeters squared | Standard Deviation 323 |
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
Population: Postural control at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Ellipse Area) at Tango Sessions | Beginning of Sessions | 749 millimeters squared | Standard Deviation 874 |
| Tango | Postural Control (Ellipse Area) at Tango Sessions | End of Sessions | 748 millimeters squared | Standard Deviation 856 |
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
Population: Postural control at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Variability) at Tango Sessions | Beginning of Sessions | 8.86 millimeters | Standard Deviation 4.43 |
| Tango | Postural Control (Variability) at Tango Sessions | End of Sessions | 8.74 millimeters | Standard Deviation 4.48 |
Postural Control (Velocity)
velocity of COP
Time frame: At baseline, week 8 of intervention, and at 4 week follow-up post intervention
Population: The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Velocity) | Baseline | 10.2 millimeters per second | Standard Deviation 6.31 |
| Tango | Postural Control (Velocity) | Week 8 | 7.51 millimeters per second | Standard Deviation 3.56 |
| Tango | Postural Control (Velocity) | Follow-up Visit (4 weeks post-intervention) | 9.21 millimeters per second | Standard Deviation 5.99 |
| Home Exercise (HEX) | Postural Control (Velocity) | Baseline | 12.1 millimeters per second | Standard Deviation 5.86 |
| Home Exercise (HEX) | Postural Control (Velocity) | Week 8 | 7.92 millimeters per second | Standard Deviation 4.12 |
| Home Exercise (HEX) | Postural Control (Velocity) | Follow-up Visit (4 weeks post-intervention) | 8.64 millimeters per second | Standard Deviation 2.79 |
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
Population: Postural control at Tango sessions were only measured for participants in the Tango arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tango | Postural Control (Velocity) at Tango Sessions | Beginning of Sessions | 8.87 millimeters per second | Standard Deviation 5.33 |
| Tango | Postural Control (Velocity) at Tango Sessions | End of Sessions | 8.08 millimeters per second | Standard Deviation 4.37 |
Quantified Clinical Measure of Balance Function
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.
Time frame: 1 month follow-up post-intervention
Quantified Clinical Measure of Balance Function
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
Time frame: 8 weeks