Cancer Survivor, Peripheral Sensory Neuropathy
Conditions
Brief summary
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
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.
Interventions
OTHEREducational Intervention
Receive readings and attend book club
BEHAVIORALExercise Intervention
Receive Tai Chi Easy class, DVD, and exercise manual
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline up to 2 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in body mass index assessed by weight and height | Baseline up to 2 months | Will be measured directly using standardized protocols with medical-quality calibrated balance scales. |
| 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 anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety) | 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 | — |
| Changes in fatigue assessed by Fatigue Symptom Inventory | Baseline up to 2 months | — |
Outcome results
None listed