Multiple MyelomaNCT02274519
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
A study testing Tai Chi and Education in people with Multiple Myeloma and Plasma Cell Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Plasma Cell Disorder
- What is being tested?
- Tai Chi and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Oct 2018
- 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
- Diagnosis of Multiple myeloma > 18 years of age or greater
- English speaking
- General proficiency to read and write in English
- Able to attend training session per study protocol
- ECOG performance status 0-1
Who cannot join
- Currently performs Tai Chi, Qi Gong, or Yoga at least once weekly or more
- Syncopal event in prior 60 days
- Current Grade 3 or > neuropathy
- Concurrent major depressive disorder or anxiety disorder (DSMIV)
- Chronic Dizziness and/or vestibular disorders
Trial locations and contacts
1 site in 1 country.
About this study
Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation?
Read the detailed description
All patients with Multiple Myeloma seen at Mayo Clinic Arizona who are undergoing evaluation for autologous stem cell transplant will be identified for potential candidacy by BMT transplant coordinator staff and referred to CRC study staff for final screen of candidacy over a period of 12 months. If eligible, ≤ 30 days prior to transplant CRC study staff will meet with patient for consent and undergo 1:1 randomization to Tai Chi versus educational control arm (N: 70). No earlier than 7 days prior to transplant all patients will attend a 1 hour session consisting of Tai Chi techniques or receive educational materials depending on the patients prior randomization and will start their intervention, subject diary and support materials will be provided. Patients will be asked to perform 30 minutes of intervention daily (Tai Chi versus educational control) and document minutes and quality of practice in their subject diary. On day 1 of autologous stem cell transplant CRC staff will administer the baseline questionnaires (NIH PROMIS Short form questionnaires for pain, depression, anxiety, social isolation, and sleep). Patients will continue their intervention (Tai chi versus educational control) daily throughout autologous stem cell transplant and record intervention fidelity in patient diary. On day 14 of transplant the NIH PROMIS questionnaires, perceived benefit questionnaire, and the meditative movement inventory for the Tai chi group only will be collected. Data collection for secondary outcomes including time to engraftment, incidence of febrile neutropenia, days of hospitalization, etc will be also gathered. Patients will continue intervention through transplant day 30 (+/- 5 days) at which time, CRC staff will collect subject diary, administer NIH PROMIS questionnaires, and a perceived benefit questionnaire. Adherence reminders will be executed once per week by CRC staff from date of initiation of intervention to completion of study.
The intervention to be tested, TCEasy, is a standardized protocol that was developed by Dr. Roger Jahnke and has been used in several prior studies including a recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors (U01 AT002706-03: PI Linda Larkey, PhD, Arizona State University, primary outcome paper currently under review). Participants will be given a written instruction manual for the Tai Chi exercises to refer to after training has been administered.
- Conditions
- Multiple Myeloma, Plasma Cell Disorder
- Being tested
- Tai Chi, Education
- Keywords
- multiple myeloma, plasma cell disorder, autologous stem cell transplant
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiOther
Arm 1
EducationOther
Arm 2
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Group randomized to participate in Tai Chi intervention Receives: Other: Tai Chi |
| Educational | Active comparator | Group randomized to participate in educational intervention Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series
Measured: 30 days
Secondary outcomes (2)
Time to engraftment
Measured: 15 days
Rate of febrile neutropenia
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startFeb 2015
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Arizona State University
- Responsible party
- Principal investigator, Nandita Khera, Mayo Clinic
- Investigators
- Nandita Khera, MD, MPH, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274519
- Sponsor's protocol ID
- 14-007210
- Status last verified
- Apr 2019
- First submitted
- 22 Oct 2014
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02274519
- Acronym / sponsor ID
- 14-007210
- Conditions
- Multiple Myeloma, Plasma Cell Disorder
- Keywords
- multiple myeloma, plasma cell disorder, autologous stem cell transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Arizona State University
- Study start
- Feb 2015
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 24 Oct 2014 (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.
Does Tai Chi Easy (TCEasy), a simple and repetitive form of exercise that consists of movements with meditation, improve quality of life in those afflicted with multiple myeloma undergoing autologous stem cell transplantation?
Detailed description
All patients with Multiple Myeloma seen at Mayo Clinic Arizona who are undergoing evaluation for autologous stem cell transplant will be identified for potential candidacy by BMT transplant coordinator staff and referred to CRC study staff for final screen of candidacy over a period of 12 months. If eligible, ≤ 30 days prior to transplant CRC study staff will meet with patient for consent and undergo 1:1 randomization to Tai Chi versus educational control arm (N: 70). No earlier than 7 days prior to transplant all patients will attend a 1 hour session consisting of Tai Chi techniques or receive educational materials depending on the patients prior randomization and will start their intervention, subject diary and support materials will be provided. Patients will be asked to perform 30 minutes of intervention daily (Tai Chi versus educational control) and document minutes and quality of practice in their subject diary. On day 1 of autologous stem cell transplant CRC staff will administer the baseline questionnaires (NIH PROMIS Short form questionnaires for pain, depression, anxiety, social isolation, and sleep). Patients will continue their intervention (Tai chi versus educational control) daily throughout autologous stem cell transplant and record intervention fidelity in patient diary. On day 14 of transplant the NIH PROMIS questionnaires, perceived benefit questionnaire, and the meditative movement inventory for the Tai chi group only will be collected. Data collection for secondary outcomes including time to engraftment, incidence of febrile neutropenia, days of hospitalization, etc will be also gathered. Patients will continue intervention through transplant day 30 (+/- 5 days) at which time, CRC staff will collect subject diary, administer NIH PROMIS questionnaires, and a perceived benefit questionnaire. Adherence reminders will be executed once per week by CRC staff from date of initiation of intervention to completion of study.
The intervention to be tested, TCEasy, is a standardized protocol that was developed by Dr. Roger Jahnke and has been used in several prior studies including a recently completed NIH/NCCAM-funded randomized controlled trial (RCT) with breast cancer survivors (U01 AT002706-03: PI Linda Larkey, PhD, Arizona State University, primary outcome paper currently under review). Participants will be given a written instruction manual for the Tai Chi exercises to refer to after training has been administered.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Other: Tai ChiGroup randomized to participate in Tai Chi intervention |
| Educational | Active comparator | Other: EducationGroup randomized to participate in educational intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Multiple myeloma > 18 years of age or greater
- English speaking
- General proficiency to read and write in English
- Able to attend training session per study protocol
- ECOG performance status 0-1
Key exclusion criteria (5 listed)
- Currently performs Tai Chi, Qi Gong, or Yoga at least once weekly or more
- Syncopal event in prior 60 days
- Current Grade 3 or > neuropathy
- Concurrent major depressive disorder or anxiety disorder (DSMIV)
- Chronic Dizziness and/or vestibular disorders
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 |
|---|---|---|
| Tai ChiArm 1 | Other | Tai Chi |
| EducationArm 2 | Other | Educational |
Primary outcome
Quality of life
Time frame: 30 days
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series
2 secondary outcomes
Time to engraftment
Time frame: 15 days
Rate of febrile neutropenia
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2019.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Nandita Khera, MD, MPH principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Education in people with Multiple Myeloma and Plasma Cell Disorder, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of life (time frame: 30 days). 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 19 Apr 2019.