DANCE-BASED AVENUES TO ADVANCE NONPHARMACOLOGIC TREATMENT OF CHEMOTHERAPY EFFECTS (DAANCE): A MULTICENTER TRIAL
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 140
- Locations
- 3
- Primary Endpoint
- Patient-Reported Outcome (PRO) - CIN sensation
Study Overview
Brief Summary
Up to 80% of breast cancer survivors experience chemotherapy-induced neuropathy that impairs quality of life and increases fall risk long into survivorship, yet treatment options for neuropathy remain limited. The successful treatment will target neurophysiologic mechanisms for restoring function while addressing patient-reported symptoms and participation in treatment. Toward this end, the investigators propose to study a noninvasive, social sensorimotor intervention - Adapted Argentine Tango - which targets motor control restoration, symptom alleviation, and treatment participation in concert.
Detailed Description
This study will investigate a noninvasive, social, sensorimotor intervention which targets motor control restoration, symptom alleviation, and treatment participation in concert: partnered Adapted Argentine Tango (Tango). This project will expand the investigators' pilot work (R21-AG068831) into a multicenter clinical trial designed to investigate the effect of social dance on sensory relief, functional restoration, and key mechanisms of action among a diverse cohort of BC survivors suffering from chronic chemotherapy-induced sensorimotor deficits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Breast Cancer (BC) diagnosis of Stage I-IV including metastatic disease
- •completed taxane-based chemotherapy for BC at least 3 months ago (no limit on how long ago)
- •symptomatic for chemotherapy-induced neuropathy (self-report)
- •postural control score that indicates potential fall-risk
- •able to understand and comply with directions associated with testing and study treatments
Exclusion Criteria
- •pre-existing vestibular dysfunction
- •poorly controlled diabetes (hgA1C>=8)
- •non-ambulatory (assistive and prosthetic devices allowed)
- •hearing impairment resulting in less than 10% hearing bilaterally
- •contraindication to participate in the experimental physical activity per the treating oncologist due to additional condition (e.g., herniated disc, unstable bone metastases)
- •currently in activity-based therapy (e.g., physical therapy, occupational therapy). May enroll if still meet eligibility criteria once activity-based therapy is complete.
Arms & Interventions
Control
4 weeks of usual care followed by optional 1-way crossover to 8 weeks of Intervention (partnered, adapted tango dance)
Experimental
8 weeks of intervention (partnered, adapted tango dance)
Intervention: Tango (Behavioral)
Outcomes
Primary Outcomes
Patient-Reported Outcome (PRO) - CIN sensation
Time Frame: 4 weeks
Sensation of numbness/tingling on 0-10 scale; minimum value 0 (no numbness/tingling); maximum value 10 (worst numbness/tingling)
Dual-task function
Time Frame: 4 weeks
Ability to move and think at the same time as measured by time to complete the Timed-Up-and-Go (TUG) test with concurrent cognitive task (i.e., counting backward by some number while completing a defined movement task)
Secondary Outcomes
- Patient-Reported Outcome (PRO) - hot/cold sensation(4 weeks; 8 weeks; 12 weeks)
- EORTC-CIPN 20(mid-intervention (4weeks); post -intervention (8 weeks); 1 month follow up post intervention)
- Brief Fatigue Inventory(4 weeks; 8 weeks; 12 weeks)
- Brief Pain Inventory(4 weeks; 8 weeks; 12 weeks)
- Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)(4 weeks; 8 weeks; 12 weeks)
- Physical Health Questionnaire-2 (PHQ-2)(4 weeks; 8 weeks; 12 weeks)
- Generalized Anxiety Questionnaire(4 weeks; 8 weeks; 12 weeks)
- Falls(4 weeks; 8 weeks; 12 weeks; 6 months following intervention end)
- The Mini Balance Evaluation Systems Test (MiniBEST)(4 weeks (Control group); 8 weeks (Intervention group))
- Biomechanical measures of postural control(4 weeks; 8 weeks; 12 weeks)
- Six minute walk test (6mwt)(4 weeks; 8 weeks)
- Gait stability(4 weeks; 8 weeks)
- Upper Extremity Function(4 weeks; 8 weeks; 12 weeks)
Investigators
Lise Worthen-Chaudhari
Principal Investigator
Ohio State University Comprehensive Cancer Center