Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

Study Overview
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Brief Summary
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This pilot clinical trial studies how well Tai Chi Easy works in treating cancer survivors with peripheral sensory neuropathy. Tai Chi Easy is a simple and repetitive form of exercise that consists of movements with meditation and may improve peripheral neuropathy symptoms among cancer survivors.

Detailed Description
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PRIMARY OBJECTIVES: I. Examine effects of Tai Chi Easy (TCEasy) exercise intervention on peripheral sensory neuropathy of cancer survivors who have chemotherapy compared with an educational control (EC) intervention. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I (TAI CHI EASY): Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks. GROUP II (EDUCATIONAL CONTROL): Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks. After completion of study, patients are followed up at 2 months.

Official Title
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Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy

Conditions
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Cancer Survivor, Peripheral Sensory Neuropathy

Intervention / Treatment
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* Other: Educational Intervention
* Behavioral: Exercise Intervention
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1 month - 5 years following completion of cytotoxic chemotherapy treatment for any cancer, and are experiencing neuropathy Self-report of >= 4 on the Peripheral Neuropathy Question Exclusion Criteria: Recurrence of cancer or other active cancer Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator) Uncontrolled diabetes, untreated hypothyroidism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (Tai Chi Easy)<br>Patients attend Tai Chi Easy class for 60 minutes once a week for 6 weeks. Patients also receive a DVD and exercise manual of Tai Chi Easy exercises and are encouraged to practice at home for 30 minutes most days per week for 6 weeks. | Behavioral: Exercise Intervention<br>* Receive Tai Chi Easy class, DVD, and exercise manual<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group II (educational control)<br>Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks. | Other: Educational Intervention<br>* Receive readings and attend book club<br>* Other names: Intervention, Educational;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peripheral sensory neuropathy, assessed by Peripheral Neuropathy Question, European Organization for Research and Treatment of Cancer (EORTC)-30, EORTC-Chemotherapy-induced peripheral neuropathy-20, and the modified Total Neuropathy Score | Will be assessed with a simple t-test of mTNS means. Additional analyses of factors assessed will similarly be conducted (and overall analysis of variance when combining outcome variable assessment at the three time points, and models of factor contribution with logistic regression if appropriate). | Baseline up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety) |  | Baseline up to 2 months | 
| Changes in body mass index assessed by weight and height | Will be measured directly using standardized protocols with medical-quality calibrated balance scales. | Baseline up to 2 months | 
| Changes in cognitive performance assessed by digit span and letter-number sequencing |  | Baseline up to 2 months | 
| Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection) |  | Baseline up to 2 months | 
| Changes in fatigue assessed by Fatigue Symptom Inventory |  | Baseline up to 2 months | 
| Changes in pain assessed by Medical Outcomes Study-Short Form 36 |  | Baseline up to 2 months | 
| Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph |  | Baseline up to 2 months |