Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01373 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 12-007483 | Other Identifier | Mayo Clinic in Arizona | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
No participants enrolled-slow accrual
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (Tai Chi Easy) | Experimental | 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) | Active Comparator | Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Receive readings and attend book club |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Donald Northfelt | Mayo Clinic | Principal Investigator |
Not provided
| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Exercise Intervention | Behavioral | Receive Tai Chi Easy class, DVD, and exercise manual |
|
| Questionnaire Administration | Other | Ancillary studies |
|
| 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 |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |