Multiple Myeloma Yoga Pilot Study

NCT06061302 | Completed

• 1 other identifier: STUDY00003083
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the feasibility of implementing a weekly yoga intervention in patients with multiple myeloma on active therapy. This study aims to analyze the impact of yoga intervention on physical symptoms (e.g. pain, fatigue, sleep), psychological symptoms (e.g. anxiety, depression), and overall health-related quality of life (HRQOL) in multiple myeloma patients on active treatment.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; yoga

Outcome Measures

Primary Outcomes (2)

• Compliance rate of weekly yoga intervention

  Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring compliance and overall completion rate of the program. Measurement: Compliance will be measured by overall percentage of patients completing 40 minutes of weekly yoga sessions in at least 8 out of 12 weeks of intervention. Completion rate will be measured by overall percentage of patients completing the 12 weeks of intervention without withdrawing or dropping out from the study. Hypothesis: Implementation of a weekly mindful yoga intervention will be feasible in multiple myeloma patients as demonstrated compliance of at least 70% patients completing 40 minutes of weekly yoga sessions in 8 out of 12 weeks of intervention.

  12 weeks

• Accrual rate of yoga intervention study

  Evaluate the feasibility of implementing a weekly 40-minute yoga intervention in patients with multiple myeloma on active treatment for 12 weeks by measuring accrual rate. Measurement: Accrual rate will be measured by overall percentage of participants enrolled in the study at the end of 3-month accrual period compared to goal accrual of total 40 participants. Hypothesis: Implementation of a weekly yoga intervention will be feasible in multiple myeloma patients as demonstrated by accrual of 40 patients (100%) over 3 months.

  12 weeks

Secondary Outcomes (4)

• Short-term impact of yoga intervention on symptom burden

  12-weeks

• Short-term impact of yoga intervention on health-related quality of life (HRQOL)

  12-weeks

• Short-term impact of yoga intervention on total daily activity

  12-weeks

• Short-term impact of yoga intervention on resting heart rate

  12-weeks

Study Arms (2)

Immediate yoga group

EXPERIMENTAL

20 participants randomized to immediate yoga intervention group will participate together in a weekly 40-minute guided mindful yoga intervention for a total of 12 consecutive weeks. After each session, participants will be asked to complete the Edmonton Symptom Assessment System (ESAS-r) through MyDataHelps app. At the end of each session, participants will be asked additional questions via MyDataHelps such as completion of yoga session on-site or remotely, the length of time they participated in the session, any additional yoga sessions during the past week, and comments regarding the session/intervention. These participants will also complete health-related quality of life (HRQOL) assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention.

Other: Immediate yoga intervention

Waitlist yoga group (delayed yoga intervention group)

ACTIVE COMPARATOR

20 participants randomized to this group will start the yoga intervention at week 13 and participate in 12 consecutive weeks of weekly 40 minute guided mindful yoga. Participants in this group will complete ESAS-r every 3 weeks and EORTC QLQ-C30 every 6 weeks for the first 12 weeks. These participants will also complete HRQOL assessment (EORTC QLQ-C30) at baseline, 6 weeks, and 12 weeks during active yoga intervention, weeks 13-24.

Other: Delayed yoga intervention

Interventions

Immediate yoga intervention OTHER

Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 1-12.

Immediate yoga group

Delayed yoga intervention OTHER

Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 13-24.

Waitlist yoga group (delayed yoga intervention group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any adult of age 18 and above
• Able to understand basic English
• Able to provide informed consent
• Diagnosis of multiple myeloma on active treatment as determined by investigators
• Good performance status as defined by European Cooperative Oncology Group score 0-1
• Able to utilize computer/laptop and smart phone
• Able and willing to travel to the yoga studio for weekly sessions
• Able to utilized a wearable device, such as Apple Watch or Fitbit (optional)

You may not qualify if:

• Poor performance status with European Cooperative Oncology Group score 2-4
• Actively participating in another clinical trial
• Poorly controlled mental health symptoms as determined by treating physician
• Reported fall or syncope in the last 2 months prior to enrollment
• Concurrent diagnosis of amyloidosis or other cancer requiring active treatment

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Shaunak Pandya, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 29, 2023
• Study Start: November 15, 2023
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)