Trial Outcomes & Findings for Tango for Neuropathy Among Breast Cancer Survivors (NCT NCT05114005)

NCT ID: NCT05114005

Last Updated: 2025-09-15

Results Overview

root-mean square of the center of pressure (COP)

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

At baseline, week 8 of intervention, and at 4 week follow-up post intervention

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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
Overall Study STARTED	26	26
Overall Study Attended Introductory Session	23	22
Overall Study Adhered Through 4 Weeks of Intervention	20	13
Overall Study Adhered Through 8 Weeks of Intervention	17	10
Overall Study Returned for 1 Month Follow-up Post Intervention	17	8
Overall Study COMPLETED	17	8
Overall Study NOT COMPLETED	9	18

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tango for Neuropathy Among Breast Cancer Survivors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tango n=26 Participants 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.	Home Exercise (HEX) n=26 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 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	Total n=52 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 8.37 • n=5 Participants	58.9 years STANDARD_DEVIATION 10.4 • n=7 Participants	61.2 years STANDARD_DEVIATION 9.65 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	26 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	25 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	26 participants n=5 Participants	26 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

root-mean square of the center of pressure (COP)

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) n=24 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
Postural Control (Variability) Baseline	10.3 millimeters Standard Deviation 4.93	9.64 millimeters Standard Deviation 2.42
Postural Control (Variability) Week 8	8.03 millimeters Standard Deviation 3.54	8.00 millimeters Standard Deviation 2.82
Postural Control (Variability) Follow-up Visit (4 weeks post-intervention)	7.74 millimeters Standard Deviation 3.67	8.61 millimeters Standard Deviation 2.31

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Tango n=20 Participants 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) n=13 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
Intrinsic Motivation 4 weeks	6 score on a scale Interval 6.0 to 11.5	21.5 score on a scale Interval 19.0 to 24.0
Intrinsic Motivation 8 weeks	6 score on a scale Interval 6.0 to 8.5	18 score on a scale Interval 14.2 to 20.0
Intrinsic Motivation 12 weeks	6 score on a scale Interval 6.0 to 6.0	16 score on a scale Interval 14.0 to 19.0

SECONDARY outcome

Timeframe: 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.

95% ellipse area of the COP

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) n=24 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
Postural Control (Ellipse Area) Baseline	1023 millimeters squared Standard Deviation 1052	775 millimeters squared Standard Deviation 441
Postural Control (Ellipse Area) Week 8	595 millimeters squared Standard Deviation 618	574 millimeters squared Standard Deviation 389
Postural Control (Ellipse Area) Follow-up Visit (4 weeks post-intervention)	570 millimeters squared Standard Deviation 606	647 millimeters squared Standard Deviation 323

SECONDARY outcome

Timeframe: 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.

velocity of COP

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) n=24 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
Postural Control (Velocity) Baseline	10.2 millimeters per second Standard Deviation 6.31	12.1 millimeters per second Standard Deviation 5.86
Postural Control (Velocity) Week 8	7.51 millimeters per second Standard Deviation 3.56	7.92 millimeters per second Standard Deviation 4.12
Postural Control (Velocity) Follow-up Visit (4 weeks post-intervention)	9.21 millimeters per second Standard Deviation 5.99	8.64 millimeters per second Standard Deviation 2.79

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) n=24 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
Postural Control (Complexity) Baseline	0.480 sample entropy score Standard Deviation 0.157	0.467 sample entropy score Standard Deviation 0.120
Postural Control (Complexity) Week 8	0.558 sample entropy score Standard Deviation 0.161	0.566 sample entropy score Standard Deviation 0.124
Postural Control (Complexity) Follow-up Visit (4 weeks post-intervention)	0.559 sample entropy score Standard Deviation 0.121	0.559 sample entropy score Standard Deviation 0.103

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) 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
Postural Control (Variability) at Tango Sessions Beginning of Sessions	8.86 millimeters Standard Deviation 4.43	—
Postural Control (Variability) at Tango Sessions End of Sessions	8.74 millimeters Standard Deviation 4.48	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) 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
Postural Control (Ellipse Area) at Tango Sessions End of Sessions	748 millimeters squared Standard Deviation 856	—
Postural Control (Ellipse Area) at Tango Sessions Beginning of Sessions	749 millimeters squared Standard Deviation 874	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) 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
Postural Control (Velocity) at Tango Sessions Beginning of Sessions	8.87 millimeters per second Standard Deviation 5.33	—
Postural Control (Velocity) at Tango Sessions End of Sessions	8.08 millimeters per second Standard Deviation 4.37	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tango n=25 Participants 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) 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
Postural Control (Complexity) at Tango Sessions Beginning of Sessions	0.520 sample entropy score Standard Deviation 0.145	—
Postural Control (Complexity) at Tango Sessions End of Sessions	0.546 sample entropy score Standard Deviation 0.180	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Tango n=16 Participants 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) n=10 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
Clinical Measure of Balance Function Baseline	10.3 seconds Standard Deviation 2.47	11.7 seconds Standard Deviation 5.21
Clinical Measure of Balance Function Week 4	8.65 seconds Standard Deviation 1.92	8.25 seconds Standard Deviation 1.74
Clinical Measure of Balance Function Follow-up Visit (4 weeks post-intervention)	8.49 seconds Standard Deviation 1.79	7.70 seconds Standard Deviation 1.25

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Tango n=22 Participants 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) 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
Neuropathy Symptoms Score at Tango Sessions Beginning of sessions	6.68 score on a scale Standard Deviation 4.25	—
Neuropathy Symptoms Score at Tango Sessions End of sessions	3.29 score on a scale Standard Deviation 3.01	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Tango n=20 Participants 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) n=10 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
Neuropathy Symptoms Score Week 8	6.60 score on a scale Standard Deviation 3.97	6.89 score on a scale Standard Deviation 7.41
Neuropathy Symptoms Score Follow-up (4 weeks post-intervention)	7.06 score on a scale Standard Deviation 4.08	5.18 score on a scale Standard Deviation 5.36

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Tango n=23 Participants 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) 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
Brief Pain Inventory Short Form at Tango Sessions Beginning of sessions	1.68 score on a scale Standard Deviation 1.59	—
Brief Pain Inventory Short Form at Tango Sessions End of sessions	1.20 score on a scale Standard Deviation 1.28	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Tango n=20 Participants 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) n=10 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
Brief Pain Inventory Short Form Week 8	1.72 score on a scale Standard Deviation 1.53	1.07 score on a scale Standard Deviation 0.999
Brief Pain Inventory Short Form Follow-up (4 weeks post-intervention)	1.78 score on a scale Standard Deviation 1.83	1.55 score on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Tango n=23 Participants 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) 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
Cancer-Related Fatigue (BFI Scores) at Tango Sessions Beginning of sessions	8.56 score on a scale Standard Deviation 9.61	—
Cancer-Related Fatigue (BFI Scores) at Tango Sessions End of sessions	1.21 score on a scale Standard Deviation 1.30	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Tango n=20 Participants 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) n=10 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
Cancer-Related Fatigue Week 8	8.13 score on a scale Standard Deviation 8.95	10.7 score on a scale Standard Deviation 11.4
Cancer-Related Fatigue Follow-up (4 weeks post intervention)	7.22 score on a scale Standard Deviation 8.72	13.3 score on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tango n=26 Participants 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) n=26 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
Number of Falls	1 number of falls	0 number of falls

SECONDARY outcome

Timeframe: at the beginning of each assessment or intervention session for up to 20 sessions, up to 8 weeks

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.

Outcome measures

Outcome measures
Measure	Tango n=26 Participants 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) n=26 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
Number of Falls	1 Number of falls	0 Number of falls

SECONDARY outcome

Timeframe: 6 months post-intervention

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

Outcome measures

Outcome measures
Measure	Tango n=26 Participants 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) n=26 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
Number of Falls	0 Number of falls	1 Number of falls

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tango n=26 Participants 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) n=26 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
Change in Dual-task Function Change between baseline to 4 weeks	-2.65 seconds Interval -3.37 to -1.94	-1.9 seconds Interval -2.77 to -1.03
Change in Dual-task Function Change between baseline and 8 weeks	-2.47 seconds Interval -3.16 to -1.78	-2.65 seconds Interval -3.52 to -1.77
Change in Dual-task Function Change between baseline and 12 weeks (follow-up visit)	-2.68 seconds Interval -3.51 to -1.84	-3.06 seconds Interval -3.96 to -2.16

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Tango n=26 Participants 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) n=26 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
Adherence Randomized	26 participants	26 participants
Adherence Attended Introductory Session	23 participants	22 participants
Adherence Adhered through 4 weeks of intervention	20 participants	13 participants
Adherence Adhered through 8 weeks of intervention	17 participants	10 participants
Adherence Returned for follow-up 1 month post- intervention (12 week timepoint)	17 participants	8 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 month follow-up post-intervention

Outcome measures

Outcome data not reported

Adverse Events

Tango (TEX)

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Home Exercise (HEX)

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tango (TEX) n=26 participants at risk 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) n=26 participants at risk 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
Blood and lymphatic system disorders Hospitalized due to low hemoglobin	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Injury, poisoning and procedural complications Hospitalized due to fall	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Injury, poisoning and procedural complications Hospitalized due to fall with broken wrist	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks

Other adverse events

Other adverse events
Measure	Tango (TEX) n=26 participants at risk 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) n=26 participants at risk 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
Gastrointestinal disorders GI distress	3.8% 1/26 • Number of events 1 • Up to 24 weeks	3.8% 1/26 • Number of events 2 • Up to 24 weeks
Infections and infestations Head cold sinuses	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Ankle pain (possibly tendonitis per Dr)	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer recurrence	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Infections and infestations COVID+	11.5% 3/26 • Number of events 3 • Up to 24 weeks	7.7% 2/26 • Number of events 2 • Up to 24 weeks
Injury, poisoning and procedural complications Fall/LOB- uninjured	23.1% 6/26 • Number of events 27 • Up to 24 weeks	7.7% 2/26 • Number of events 2 • Up to 24 weeks
General disorders Feeling unwell/ cold	15.4% 4/26 • Number of events 6 • Up to 24 weeks	26.9% 7/26 • Number of events 10 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Hip pain	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Skin and subcutaneous tissue disorders Infection Axilla	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Infections and infestations Infection Sinus/Ear	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Knee pain	11.5% 3/26 • Number of events 3 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Nervous system disorders Migraine	3.8% 1/26 • Number of events 1 • Up to 24 weeks	7.7% 2/26 • Number of events 2 • Up to 24 weeks
Surgical and medical procedures Planned surgery: chemo port removed	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Surgical and medical procedures Planned surgery: melanoma removed	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Plantar fasciitis	3.8% 1/26 • Number of events 1 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Skin and subcutaneous tissue disorders Poison ivy	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Shoulder pain during tango INT	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Infections and infestations Sinus infection	3.8% 1/26 • Number of events 1 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Stress fracture hip	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Thumb strain	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Injury, poisoning and procedural complications Tripped; would have fallen if son-in-law hadn't caught	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Skin and subcutaneous tissue disorders Vaccine reaction	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Infections and infestations Walking pneumonia	3.8% 1/26 • Number of events 1 • Up to 24 weeks	0.00% 0/26 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Broken toe	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Metabolism and nutrition disorders Dehydration	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Surgical and medical procedures Endoscopy	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Infections and infestations Kidney infection	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Knee arthritis pain	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Left hip discomfort	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Nervous system disorders Long COVID headache	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Nervous system disorders Nerve pain	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Infections and infestations Pneumonia	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Infections and infestations Sinus infection and symptoms of POTS	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Steroid injection for foot pain	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Cardiac disorders Symptoms of Postural Orthostatic Tachycardia Syndrome (POTS)	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Trauma to toe	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks
Musculoskeletal and connective tissue disorders Trigger finger	0.00% 0/26 • Up to 24 weeks	3.8% 1/26 • Number of events 1 • Up to 24 weeks

Additional Information

Dr. Lise Worthen-Chaudhari

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-6281

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place