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Completed

NCT Number: NCT06061302

Multiple Myeloma Yoga Pilot Study

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Immediate yoga intervention

Other

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

Delayed yoga intervention

Other

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

Primary outcomes

  1. Compliance rate of weekly yoga intervention

    Time frame: 12 weeks

    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.

  2. Accrual rate of yoga intervention study

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Short-term impact of yoga intervention on symptom burden

    Time frame: 12-weeks

    Evaluate the short-term impact of weekly yoga intervention in patients with multiple myeloma on active treatment on symptom burden by measuring Edmonton Symptom Assessment System (ESAS-r) after each session weekly.

    Measurement: Patient-reported scores will be measured after 40-minute yoga intervention each week using ESAS-r and they will be compared to baseline. Symptom assessment scale ranges from 0 (best) to 10 (worst).

    Hypothesis: Patients with multiple myeloma on active treatment will have statistically significant improvement in symptom burden compared to baseline after 40-minute yoga intervention each week.

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

    Time frame: 12-weeks

    Evaluate the impact of a weekly 12-week yoga intervention program in patients with multiple myeloma on active treatment on health-related quality of life (HRQOL) over 12 weeks by measuring HRQOL questionnaire, European Organization For Research and Treatment Of Cancer-Core Quality of Life Questionnaire (EORTC QLQ-C30), responses at baseline, 6 and 12 weeks.

    Measurement: Overall health-related quality of life in participants will be measured at baseline, 6 and 12 weeks using EORTC QLQ-C30 assessment tool and scores will be compared to baseline. Scores range from 0 to 100 with higher numbers indicating higher function and quality of life. Subscale for symptom burden will indicate higher symptom burden with higher score values. Hypothesis: Patients with multiple myeloma on active treatment will have statistically significant improvement in HRQOL scores (measured by EORTC QLQ-C30) at 6 and 12 weeks compared to baseline and controls due to 12-week mindful yoga intervention.

  3. Short-term impact of yoga intervention on total daily activity

    Time frame: 12-weeks

    Evaluate the impact of a 12-week mindful yoga intervention program in patients with multiple myeloma on active treatment on total daily activity measured by total daily steps using wearable device (FitBit).

    Measurement: Total daily steps will be measured in each participant using a wearable device (FitBit), and mean values from each week will be compared at baseline, 6 weeks, and 12 weeks.

    Hypothesis: Patients with multiple myeloma on active treatment undergoing yoga intervention will have increased total daily activity (daily steps) at 6 weeks and 12 weeks.

  4. Short-term impact of yoga intervention on resting heart rate

    Time frame: 12-weeks

    Evaluate the impact of a 12-week mindful yoga intervention program in patients with multiple myeloma on active treatment on resting heart rate using wearable device (FitBit).

    Measurement: Resting heart rate will be measured in each participant using a wearable device (FitBit), and mean resting heart rate values from each week will be compared at baseline, 6 weeks, and 12 weeks.

    Hypothesis: Patients with multiple myeloma on active treatment undergoing yoga intervention will have decreased resting heart rate at 6 weeks and 12 weeks.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

A Randomized Pilot Study of Yoga Intervention in Patients With Multiple Myeloma on Active Therapy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Jul 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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