NCT01980368

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2013

Completed
20 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2017

Completed
Last Updated

March 12, 2018

Status Verified

March 1, 2018

Enrollment Period

3.5 years

First QC Date

July 12, 2013

Last Update Submit

March 8, 2018

Conditions

Cancer SurvivorPeripheral Sensory Neuropathy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

    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

  • +2 more secondary outcomes

Study Arms (2)

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.

Behavioral: Exercise InterventionOther: Questionnaire Administration

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.

Other: Educational InterventionOther: Questionnaire Administration

Interventions

Educational InterventionOTHER

Receive readings and attend book club

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Group II (educational control)
Exercise InterventionBEHAVIORAL

Receive Tai Chi Easy class, DVD, and exercise manual

Group I (Tai Chi Easy)
Questionnaire AdministrationOTHER

Ancillary studies

Group I (Tai Chi Easy)Group II (educational control)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Recurrence of cancer or other active cancer
  • Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
  • Uncontrolled diabetes, untreated hypothyroidism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Early Intervention, EducationalEducational StatusMethods

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health ServicesSocioeconomic FactorsPopulation CharacteristicsInvestigative Techniques

Study Officials

  • Donald Northfelt

    Mayo Clinic

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2013

First Posted

November 11, 2013

Study Start

August 1, 2013

Primary Completion

January 18, 2017

Study Completion

January 18, 2017

Last Updated

March 12, 2018

Record last verified: 2018-03