Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

NCT ID: NCT02274519

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-10-31

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.

Conditions

Multiple Myeloma; Plasma Cell Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Tai Chi

Group randomized to participate in Tai Chi intervention

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: OTHER

Arm 1

Educational

Group randomized to participate in educational intervention

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

Arm 2

Interventions

Tai Chi

Arm 1

Intervention Type: OTHER

Education

Arm 2

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arizona State University

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Nandita Khera

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nandita Khera, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

14-007210

Identifier Type: -

Identifier Source: org_study_id