Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02274519

Collaborator

Arizona State University (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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?

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Plasma Cell Disorder	Other: Tai Chi Other: Education	N/A

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

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Oct 1, 2018

Actual Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tai Chi Group randomized to participate in Tai Chi intervention	Other: Tai Chi Arm 1
Active Comparator: Educational Group randomized to participate in educational intervention	Other: Education Arm 2

Arm

Intervention/Treatment

Experimental: Tai Chi

Group randomized to participate in Tai Chi intervention

Other: Tai Chi

Arm 1

Active Comparator: Educational

Group randomized to participate in educational intervention

Other: Education

Arm 2

Outcome Measures

Primary Outcome Measures

Quality of life [30 days]
Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series

Secondary Outcome Measures

Time to engraftment [15 days]
Rate of febrile neutropenia [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Arizona	Scottsdale	Arizona	United States	85259

Sponsors and Collaborators

Mayo Clinic
Arizona State University

Investigators

Principal Investigator: Nandita Khera, MD, MPH, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Nandita Khera, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT02274519

Other Study ID Numbers:

14-007210

First Posted:

Oct 24, 2014

Last Update Posted:

Apr 19, 2019

Last Verified:

Apr 1, 2019

Keywords provided by Nandita Khera, Principal Investigator, Mayo Clinic

multiple myeloma

plasma cell disorder

autologous stem cell transplant

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Apr 19, 2019