Multiple Myeloma Yoga Pilot Study

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06061302
• Other study ID #: STUDY00003083
• Status: Suspended
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Immediate yoga intervention
Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 1-12.
• Delayed yoga intervention
Subjects will complete 12 consecutive weeks of weekly 40 minute guided mindful yoga weeks 13-24.

Locations

Country	Name	City	State
United States	University of Arizona Cancer Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Short-term impact of yoga intervention on symptom burden	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.	12-weeks
Secondary	Short-term impact of yoga intervention on health-related quality of life (HRQOL)	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.	12-weeks
Secondary	Short-term impact of yoga intervention on total daily activity	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.	12-weeks
Secondary	Short-term impact of yoga intervention on resting heart rate	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.	12-weeks