Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Novel Support Options in Autologous Stem Cell Transplant for Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274519
• Other study ID #: 14-007210
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: October 2018

Study information

• Verified date: April 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Plasma Cell Disorder

Intervention

Other:
• Tai Chi
Arm 1
• Education
Arm 2

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life	Quality of life measures including pain, depression, anxiety, social isolation, and sleep utilizing NIH promis SF series	30 days
Secondary	Time to engraftment		15 days
Secondary	Rate of febrile neutropenia		30 days

External Links

•   Mayo Clinic Clinical Trials