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Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

Primary Purpose

Cancer Survivor, Peripheral Sensory Neuropathy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Educational Intervention
Exercise Intervention
Questionnaire Administration
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer Survivor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group I (Tai Chi Easy)

    Group II (educational control)

    Arm Description

    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.

    Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
    Changes in body mass index assessed by weight and height
    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
    Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
    Changes in fatigue assessed by Fatigue Symptom Inventory
    Changes in pain assessed by Medical Outcomes Study-Short Form 36
    Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph

    Full Information

    First Posted
    July 12, 2013
    Last Updated
    March 8, 2018
    Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01980368
    Brief Title
    Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
    Official Title
    Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled-slow accrual
    Study Start Date
    August 2013 (undefined)
    Primary Completion Date
    January 18, 2017 (Actual)
    Study Completion Date
    January 18, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mayo Clinic
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Survivor, Peripheral Sensory Neuropathy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I (Tai Chi Easy)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Group II (educational control)
    Arm Type
    Active Comparator
    Arm Description
    Patients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Educational Intervention
    Other Intervention Name(s)
    Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
    Intervention Description
    Receive readings and attend book club
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise Intervention
    Intervention Description
    Receive Tai Chi Easy class, DVD, and exercise manual
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire Administration
    Intervention Description
    Ancillary studies
    Primary Outcome Measure Information:
    Title
    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
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
    Time Frame
    Baseline up to 2 months
    Title
    Changes in body mass index assessed by weight and height
    Description
    Will be measured directly using standardized protocols with medical-quality calibrated balance scales.
    Time Frame
    Baseline up to 2 months
    Title
    Changes in cognitive performance assessed by digit span and letter-number sequencing
    Time Frame
    Baseline up to 2 months
    Title
    Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
    Time Frame
    Baseline up to 2 months
    Title
    Changes in fatigue assessed by Fatigue Symptom Inventory
    Time Frame
    Baseline up to 2 months
    Title
    Changes in pain assessed by Medical Outcomes Study-Short Form 36
    Time Frame
    Baseline up to 2 months
    Title
    Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
    Time Frame
    Baseline up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Donald Northfelt
    Organizational Affiliation
    Mayo Clinic
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy

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