An interventional study of Educational Intervention and Exercise Intervention in Cancer Survivor and Peripheral Sensory Neuropathy, sponsored by Mayo Clinic. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-12.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
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 · Other: Questionnaire Administration
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 · Other: Questionnaire Administration
Receive readings and attend book club
Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive Tai Chi Easy class, DVD, and exercise manual
Ancillary studies
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).
Time frame: Baseline up to 2 months
Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
Time frame: 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.
Time frame: Baseline up to 2 months
Changes in cognitive performance assessed by digit span and letter-number sequencing
Time frame: Baseline up to 2 months
Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
Time frame: Baseline up to 2 months
Changes in fatigue assessed by Fatigue Symptom Inventory
Time frame: Baseline up to 2 months
Changes in pain assessed by Medical Outcomes Study-Short Form 36
Time frame: Baseline up to 2 months
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
Time frame: Baseline up to 2 months
No study locations are listed for this record.
This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Peripheral Nervous System Diseases→
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