Cancer SurvivorNCT01980368
Tai Chi Easy in Treating Cancer Survivors With Peripheral Sensory Neuropathy
A study testing Educational Intervention, Exercise Intervention and Questionnaire Administration in people with Cancer Survivor and Peripheral Sensory Neuropathy, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivor, Peripheral Sensory Neuropathy
- What is being tested?
- Educational Intervention, Exercise Intervention and Questionnaire Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to 18 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Recurrence of cancer or other active cancer
- Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
- Uncontrolled diabetes, untreated hypothyroidism
About this study
Official title: Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cancer Survivor, Peripheral Sensory Neuropathy
- Being tested
- Educational Intervention, Exercise Intervention, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive readings and attend book club
Exercise InterventionBehavioural
Receive Tai Chi Easy class, DVD, and exercise manual
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise Intervention; Other: 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. Receives: Other: Educational Intervention; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline up to 2 months
Secondary outcomes (7)
Changes in anxiety assessed by POMS Total Mood Disturbance dimensions (tension-anxiety)
Measured: 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.
Measured: Baseline up to 2 months
Changes in cognitive performance assessed by digit span and letter-number sequencing
Measured: Baseline up to 2 months
Changes in depression assessed by Program Operations Manual System (POMS) Total Mood Disturbance dimensions (depression-dejection)
Measured: Baseline up to 2 months
Changes in fatigue assessed by Fatigue Symptom Inventory
Measured: Baseline up to 2 months
Changes in pain assessed by Medical Outcomes Study-Short Form 36
Measured: Baseline up to 2 months
Changes in sleep quality assessed by Pittsburgh Sleep Quality Index and actigraph
Measured: Baseline up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startAug 2013
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Why it stopped: No participants enrolled-slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer SurvivorStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Donald Northfelt, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980368
- Sponsor's protocol ID
- 12-007483
- Other IDs
- NCI-2016-01373, 12-007483, P30CA015083
- Status last verified
- Mar 2018
- First submitted
- 12 Jul 2013
- Last updated
- 12 Mar 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Effects of Tai Chi Easy on Cancer Survivors Experiencing Neuropathy
- ClinicalTrials.gov ID
- NCT01980368
- Acronym / sponsor ID
- 12-007483
- Conditions
- Cancer Survivor, Peripheral Sensory Neuropathy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled-slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2013
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Tai Chi Easy) | Experimental | Behavioral: Exercise Intervention, Other: Questionnaire AdministrationPatients 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 | Other: Educational Intervention, Other: Questionnaire AdministrationPatients receive readings each week and attend a book club to discuss the readings for 60 minutes once a week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Recurrence of cancer or other active cancer
- Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
- Uncontrolled diabetes, untreated hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive readings and attend book club | Other | Group II (educational control) |
| Exercise InterventionReceive Tai Chi Easy class, DVD, and exercise manual | Behavioural | Group I (Tai Chi Easy) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Tai Chi Easy), Group II (educational control) |
Primary outcome
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
Time frame: 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).
7 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald Northfelt principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Exercise Intervention and Questionnaire Administration in people with Cancer Survivor and Peripheral Sensory Neuropathy, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.