Multiple Myeloma Yoga Pilot Study

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Immediate yoga intervention

Delayed yoga intervention

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring Multiple Myeloma, yoga

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Arizona Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate yoga group

Waitlist yoga group (delayed yoga intervention group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT06061302

First Posted

August 29, 2023

Last Updated

September 27, 2023

Sponsor

University of Arizona

1. Study Identification

Unique Protocol Identification Number

NCT06061302

Brief Title

Multiple Myeloma Yoga Pilot Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 1, 2023 (Anticipated)

Primary Completion Date

July 1, 2024 (Anticipated)

Study Completion Date

July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Myeloma

Keywords

Multiple Myeloma, yoga

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate yoga group

Arm Type

Experimental

Arm Description

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.

Arm Title

Waitlist yoga group (delayed yoga intervention group)

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Immediate yoga intervention

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Delayed yoga intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Compliance rate of weekly yoga intervention

Description

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.

Time Frame

12 weeks

Title

Accrual rate of yoga intervention study

Description

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.

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Short-term impact of yoga intervention on symptom burden

Description

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.

Time Frame

12-weeks

Title

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

Description

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.

Time Frame

12-weeks

Title

Short-term impact of yoga intervention on total daily activity

Description

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.

Time Frame

12-weeks

Title

Short-term impact of yoga intervention on resting heart rate

Description

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.

Time Frame

12-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ashley Larsen, MS

Phone

5206267761

Email

golmana@email.arizona.edu

First Name & Middle Initial & Last Name or Official Title & Degree

UACC IIT

Email

UACC-IIT@uacc.arizona.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaunak Pandya, MD

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Arizona Cancer Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85719

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shaunak Pandya, MD

Phone

480-385-8765

Email

skpandya@arizona.edu

First Name & Middle Initial & Last Name & Degree

Ashley Larsen

Phone

520-626-7761

Email

golmana@arizona.edu

First Name & Middle Initial & Last Name & Degree

Shaunak Pandya, MD

First Name & Middle Initial & Last Name & Degree

Krisstina Gowin, DO

First Name & Middle Initial & Last Name & Degree

Reya Sharman, MD

12. IPD Sharing Statement

Plan to Share IPD

No

Multiple Myeloma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial