Multiple Myeloma Clinical Trial
Official title:
Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma
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?
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.
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