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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-00310 | Registry Identifier | CTRP | |
| R21AG068831 | U.S. NIH Grant/Contract | View source | |
| OSU-15047 | Other Identifier | Ohio State University Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tango | Experimental | 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. |
|
| Home Exercise (HEX) | Active Comparator | 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 hour training (i.e., endurance, resistance, and sensorimotor) performed 2x per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhythmic Auditory Stimulation | Behavioral | Rhythmically-entrained sensorimotor activity. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Control (Variability) | root-mean square of the center of pressure (COP) | 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. | Assessed at week 4, week 8, and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Postural Control (Ellipse Area) | 95% ellipse area of the COP | At baseline, week 8 of intervention, and at 4 week follow-up post intervention |
| Postural Control (Velocity) | velocity of COP |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lise Worthen-Chaudhari, PhD, MFA | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephanie Spielman Comprehensive Breast Center | Columbus | Ohio | 43212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30369677 | Background | 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. | |
| 28963591 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Postural Control (Variability) | root-mean square of the center of pressure (COP) | The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint. | Posted | Mean | Standard Deviation | millimeters | At baseline, week 8 of intervention, and at 4 week follow-up post intervention |
|
Up to 24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tango (TEX) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalized due to low hemoglobin | Blood and lymphatic system disorders | CTCAE v.5.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle pain (possibly tendonitis per Dr) | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lise Worthen-Chaudhari | The Ohio State University Comprehensive Cancer Center | 614-293-6281 | wort08@osumc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2015 | Jul 1, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 19, 2021 | Jul 1, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Evidence-Based Exercise |
| Behavioral |
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 |
|
| 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 | 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. | 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. | 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. | 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 | 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. | 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 | 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. | 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 | 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). | 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 | 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). | 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. | 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. | 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 | 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. | 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 | Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks |
| 8 weeks |
| 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. | 1 month follow-up post-intervention |
| 38962217 | Derived | Worthen-Chaudhari L, Schnell PM, Hackney ME, Lustberg MB. Partnered dance evokes greater intrinsic motivation than home exercise as therapeutic activity for chemotherapy-induced deficits: secondary results of a randomized, controlled clinical trial. Front Psychol. 2024 Jun 19;15:1383143. doi: 10.3389/fpsyg.2024.1383143. eCollection 2024. |
| 37658464 | Derived | Lantis K, Schnell P, Bland CR, Wilder J, Hock K, Vargo C, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trial and preliminary baseline data. Trials. 2023 Sep 1;24(1):564. doi: 10.1186/s13063-023-07554-z. |
| 37461666 | Derived | Lantis KD, Schne P, Bland CR, Wilder J, Hock K, Glover NA, Hackney ME, Lustberg MB, Worthen-Chaudhari L. Biomechanical effect of neurologic dance training (NDT) for breast cancer survivors with chemotherapy-induced neuropathy: study protocol for a randomized controlled trail and preliminary baseline data. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-2988661. doi: 10.21203/rs.3.rs-2988661/v1. |
| BG001 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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
|
|
| Primary | 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. | 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 | Posted | Median | Inter-Quartile Range | score on a scale | Assessed at week 4, week 8, and week 12 |
|
|
|
| Secondary | Postural Control (Ellipse Area) | 95% ellipse area of the COP | The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint. | Posted | Mean | Standard Deviation | millimeters squared | At baseline, week 8 of intervention, and at 4 week follow-up post intervention |
|
|
|
| Secondary | Postural Control (Velocity) | velocity of COP | The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint. | Posted | Mean | Standard Deviation | millimeters per second | At baseline, week 8 of intervention, and at 4 week follow-up post intervention |
|
|
|
| Secondary | 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 | The number of participants analyzed at each time point represents the number who participated in the postural control tests at each timepoint. | Posted | Mean | Standard Deviation | sample entropy score | At baseline, week 8 of intervention, and at 4 week follow-up post intervention |
|
|
|
| Secondary | 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. | Postural control at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | millimeters | at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
|
|
|
| Secondary | 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. | Postural control at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | millimeters squared | at the beginning and at the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
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| Secondary | 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. | Postural control at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | millimeters per second | at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
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| Secondary | 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 | Postural control at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | sample entropy score | at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
|
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|
| Secondary | 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. | The number of participants analyzed represents the number who completed the TUG tests at each timepoint. | Posted | Mean | Standard Deviation | seconds | At baseline, week 4 of intervention, and at 4 week follow-up post intervention, up to 12 weeks |
|
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| Secondary | 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 | Neuropathy symptoms scores at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | score on a scale | at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
|
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| Secondary | 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. | The number of participants analyzed is the number of participants for which neuropathy symptoms scores were collected at each time point | Posted | Mean | Standard Deviation | score on a scale | At week 8 of intervention and at 4-week follow-up post intervention |
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| Secondary | 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 | BPI scores at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | score on a scale | at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
|
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| Secondary | 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). | The number of participants analyzed is the number of participants for which BPI scores were collected at each time point | Posted | Mean | Standard Deviation | score on a scale | At week 8 of intervention and at 4-week follow-up post intervention |
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| Secondary | 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 | BFI scores at Tango sessions were only measured for participants in the Tango arm. | Posted | Mean | Standard Deviation | score on a scale | at the beginning and the end of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
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| Secondary | 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). | The number of participants analyzed is the number of participants for which BFI scores were collected at each time point | Posted | Mean | Standard Deviation | score on a scale | At week 8 and at 4-week follow-up visit post intervention |
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| Secondary | 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. | Posted | Number | number of falls | once at the point of study enrollment |
|
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| Secondary | 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. | Posted | Number | Number of falls | at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks |
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| Secondary | 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 | Posted | Number | Number of falls | 6 months post-intervention |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | seconds | Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks |
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| Secondary | Adherence | Adherence is measured by the number of enrollees who participated through each time point of the study | Posted | Number | participants | Assessed at baseline, 4 weeks, 8 weeks, and 12 weeks |
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| Other Pre-specified | 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 | Not Posted | 8 weeks | Participants |
| Other Pre-specified | 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. | Not Posted | 1 month follow-up post-intervention | Participants |
| 0 |
| 26 |
| 1 |
| 26 |
| 19 |
| 26 |
| EG001 | 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 | 0 | 26 | 2 | 26 | 11 | 26 |
| Hospitalized due to fall | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
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| Hospitalized due to fall with broken wrist | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
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| Cancer recurrence | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE v.5.0 | Systematic Assessment |
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| COVID+ | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Fall/LOB- uninjured | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
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| Feeling unwell/ cold | General disorders | CTCAE v.5.0 | Systematic Assessment |
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| GI distress | Gastrointestinal disorders | CTCAE v.5.0 | Systematic Assessment |
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| Head cold sinuses | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Hip pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Infection Axilla | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Infection Sinus/Ear | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Knee pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Planned surgery: chemo port removed | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
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| Planned surgery: melanoma removed | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
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| Plantar fasciitis | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Poison ivy | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Shoulder pain during tango INT | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Sinus infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Stress fracture hip | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Thumb strain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Tripped; would have fallen if son-in-law hadn't caught | Injury, poisoning and procedural complications | CTCAE v.5.0 | Systematic Assessment |
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| Vaccine reaction | Skin and subcutaneous tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Walking pneumonia | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Broken toe | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE v.5.0 | Systematic Assessment |
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| Endoscopy | Surgical and medical procedures | CTCAE v.5.0 | Systematic Assessment |
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| Kidney infection | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Knee arthritis pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Left hip discomfort | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Long COVID headache | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Nerve pain | Nervous system disorders | CTCAE v.5.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Sinus infection and symptoms of POTS | Infections and infestations | CTCAE v.5.0 | Systematic Assessment |
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| Steroid injection for foot pain | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Symptoms of Postural Orthostatic Tachycardia Syndrome (POTS) | Cardiac disorders | CTCAE v.5.0 | Systematic Assessment |
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| Trauma to toe | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | CTCAE v.5.0 | Systematic Assessment |
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Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |
| 8 weeks |
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| 12 weeks |
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| Week 8 |
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| Follow-up Visit (4 weeks post-intervention) |
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| Week 8 |
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| Follow-up Visit (4 weeks post-intervention) |
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| Week 8 |
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| Follow-up Visit (4 weeks post-intervention) |
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| Week 4 |
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| Follow-up Visit (4 weeks post-intervention) |
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| Follow-up (4 weeks post-intervention) |
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| Follow-up (4 weeks post-intervention) |
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| Follow-up (4 weeks post intervention) |
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| Change between baseline and 12 weeks (follow-up visit) |
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| Adhered through 4 weeks of intervention |
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| Adhered through 8 weeks of intervention |
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| Returned for follow-up 1 month post- intervention (12 week timepoint) |
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