Multiple Myeloma Yoga Pilot Study

NCT ID: NCT06061302

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2025-07-16

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Immediate yoga group

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.

Group Type EXPERIMENTAL

Immediate yoga intervention

Intervention Type OTHER

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

Waitlist yoga group (delayed yoga intervention group)

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.

Group Type ACTIVE_COMPARATOR

Delayed yoga intervention

Intervention Type OTHER

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

Interventions

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Immediate yoga intervention

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

Intervention Type OTHER

Delayed yoga intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaunak Pandya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

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University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003083

Identifier Type: -

Identifier Source: org_study_id

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