Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
Primary Purpose
Multiple Myeloma, Plasma Cell Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Education
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Myeloma focused on measuring multiple myeloma, plasma cell disorder, autologous stem cell transplant
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Mayo Clinic in Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Tai Chi
Educational
Arm Description
Group randomized to participate in Tai Chi intervention
Group randomized to participate in educational intervention
Outcomes
Primary Outcome Measures
Quality of life
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series
Secondary Outcome Measures
Time to engraftment
Rate of febrile neutropenia
Full Information
NCT ID
NCT02274519
First Posted
October 22, 2014
Last Updated
April 17, 2019
Sponsor
Mayo Clinic
Collaborators
Arizona State University
1. Study Identification
Unique Protocol Identification Number
NCT02274519
Brief Title
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
Official Title
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Arizona State University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Plasma Cell Disorder
Keywords
multiple myeloma, plasma cell disorder, autologous stem cell transplant
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
Group randomized to participate in Tai Chi intervention
Arm Title
Educational
Arm Type
Active Comparator
Arm Description
Group randomized to participate in educational intervention
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
Arm 1
Intervention Type
Other
Intervention Name(s)
Education
Intervention Description
Arm 2
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to engraftment
Time Frame
15 days
Title
Rate of febrile neutropenia
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nandita Khera, MD, MPH
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
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