Yoga for Multiple Myeloma
Recruiting in Palo Alto (17 mi)
Overseen byShaunak Pandya, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: University of Arizona
Disqualifiers: Poor performance status, Other trial, Mental health, Fall, Others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. It focuses on patients with multiple myeloma who are already on active treatment.
What data supports the effectiveness of the treatment Yoga for Multiple Myeloma?
Is yoga generally safe for humans?
How does yoga treatment differ from other treatments for multiple myeloma?
Yoga is a unique treatment for multiple myeloma as it focuses on improving quality of life by reducing physical and emotional symptoms like fatigue and anxiety, rather than directly targeting the cancer itself. Unlike traditional drug treatments, yoga is a non-drug, mind-body intervention that can be used alongside standard medical care to help patients cope with the challenges of cancer treatment.19101112
Eligibility Criteria
This trial is for adults over 18 with multiple myeloma who are currently receiving treatment. Participants should be able to use a computer or smartphone, attend weekly yoga sessions at a studio, and understand English. They must be in good physical condition as judged by specific medical criteria and not involved in another clinical study.Inclusion Criteria
Able to utilize a wearable device, such as Apple Watch or Fitbit (optional)
I am currently receiving treatment for multiple myeloma.
I am fully active or able to carry out light work.
See 5 more
Exclusion Criteria
Your doctor thinks your mental health symptoms are not well managed.
I do not have amyloidosis or another cancer needing treatment.
Actively participating in another clinical trial
See 2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive a weekly 40-minute guided mindful yoga intervention for 12 consecutive weeks
12 weeks
12 visits (in-person or remote)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Waitlist Yoga Intervention
Participants in the waitlist group start the yoga intervention at week 13 for 12 consecutive weeks
12 weeks
Treatment Details
Interventions
- Delayed yoga intervention (Behavioural Intervention)
- Immediate yoga intervention (Behavioural Intervention)
Trial OverviewThe study tests how feasible it is to have weekly yoga sessions for multiple myeloma patients undergoing treatment. It looks at the effects of yoga on physical discomforts like pain and fatigue, mental health issues such as anxiety, and overall life quality.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate yoga groupExperimental Treatment1 Intervention
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 II: Waitlist yoga group (delayed yoga intervention group)Active Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Arizona Cancer CenterTucson, AZ
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Who Is Running the Clinical Trial?
University of ArizonaLead Sponsor
References
The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial. [2017]Background Several cognitive behavioral interventions have been reported to reduce psychological symptoms in breast cancer (BC) patients. The goal of this study was to evaluate the effects of a yoga intervention in reducing depression and anxiety symptoms in BC patients. Methods This study was a randomized, partially blinded, controlled trial comparing a standardized yoga intervention to standard care. It was conducted at three medical centers in Montreal, Canada. Eligible patients were women diagnosed with stage I-III BC receiving chemotherapy. Participants were randomly assigned to receive yoga intervention immediately (experimental group, n=58) or after a waiting period (n=43 control group). The Bali Yoga Program for Breast Cancer Patients (BYP-BC) consisted of 23 gentle Hatha asanas (poses), 2 prayanamas (breathing techniques), shavasanas (relaxation corpse poses) and psychoeducational themes. Participants attended eight weekly sessions lasting 90 min each and received a DVD for home practice with 20- and 40-min sessions. Participants in the wait list control group received standard care during the 8-week waiting period. Results A total of 101 participants took part in the final intention-to-treat analyses. The repeated measures analyses demonstrated that depression symptoms increased in the control group (p=0.007), while no change was reported in the BYP-BC group (p=0.29). Also, depression symptoms decreased in the WL control group after receiving the BYP-BC intervention (p=0.03). Finally, there was no statistical significance in terms of anxiety symptoms (p=0.10). Conclusions Results support the BYP-BC intervention as a beneficial means of reducing and preventing the worsening of depression symptoms during chemotherapy treatment.
Yoga for Patients with Early Breast Cancer and its Impact on Quality of Life - a Randomized Controlled Trial. [2021]The aim of this prospective, randomized, controlled trial was to investigate the impact of yoga on newly diagnosed patients with early breast cancer in the immediate postoperative phase. 93 women newly diagnosed with early breast cancer were randomized into an intervention group (IG) and a control group (waiting group, WG). The IG started yoga immediately after the operation. The WG started yoga 5 weeks after surgery. Both groups attended yoga classes twice weekly for 5 weeks. Quality of life (QoL) was evaluated using the EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires before the intervention, immediately after the operation and after 3 months. After 3 months the patients were asked whether yoga improved their physical activity and whether they wished to continue with yoga. The overall QoL (p = 0.002) and the functional status (p = 0.005) increased significantly in the IG, while physical symptoms decreased over time in both groups. 86 % of patients in the IG and only 59 % of patients in the WG (p = 0.04) confirmed a positive change in their physical activity through yoga. More women in the IG intended to continue with yoga (p = 0.03). Early initiation of yoga as a supportive treatment in cancer had a positive impact on QoL. Teaching yoga allowed patients to practice yoga by themselves, enhanced the patients' QoL and was found to improve physical activity.
Yoga and quality-of-life improvement in patients with breast cancer: a literature review. [2012]Women undergoing treatment for breast cancer often turn to complementary and alternative medicine (CAM), including yoga, for improvement of mood, quality of life (QOL), sleep, and treatment-related side effects. The extant literature was reviewed to examine the clinical effects of yoga practice on QOL for patients with breast cancer. QOL was defined as physical well-being, social functioning, emotional health, and function-al adaptation.
Yoga for symptom management in oncology: A review of the evidence base and future directions for research. [2023]Because yoga is increasingly recognized as a complementary approach to cancer symptom management, patients/survivors and providers need to understand its potential benefits and limitations both during and after treatment. The authors reviewed randomized controlled trials (RCTs) of yoga conducted at these points in the cancer continuum (N = 29; n = 13 during treatment, n = 12 post-treatment, and n = 4 with mixed samples). Findings both during and after treatment demonstrated the efficacy of yoga to improve overall quality of life (QOL), with improvement in subdomains of QOL varying across studies. Fatigue was the most commonly measured outcome, and most RCTs conducted during or after cancer treatment reported improvements in fatigue. Results also suggested that yoga can improve stress/distress during treatment and post-treatment disturbances in sleep and cognition. Several RCTs provided evidence that yoga may improve biomarkers of stress, inflammation, and immune function. Outcomes with limited or mixed findings (eg, anxiety, depression, pain, cancer-specific symptoms, such as lymphedema) and positive psychological outcomes (such as benefit-finding and life satisfaction) warrant further study. Important future directions for yoga research in oncology include: enrolling participants with cancer types other than breast, standardizing self-report assessments, increasing the use of active control groups and objective measures, and addressing the heterogeneity of yoga interventions, which vary in type, key components (movement, meditation, breathing), dose, and delivery mode.
Effect of yoga on patients with cancer: our current understanding. [2022]To determine whether therapeutic yoga improves the quality of life of patients with cancer.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
Feasibility of a yoga, aerobic and stretching-toning exercise program for adult cancer survivors: the STAYFit trial. [2022]The use of yoga as a mind-body practice has become increasingly popular among clinical populations and older adults who use this practice to manage age and chronic disease-related symptoms. Although yoga continues to gain popularity among practitioners and researchers, pilot studies that examine its feasibility and acceptability, especially among cancer survivors, are limited. Feasibility studies play a critical role in determining whether the target population is likely to engage with larger scale efficacy and effectiveness trials. In this paper we present feasibility and acceptability data from a 12-week randomized controlled trial (RCT) conducted with adult cancer survivors.
Influence of Yoga on Cancer-Related Fatigue and on Mediational Relationships Between Changes in Sleep and Cancer-Related Fatigue: A Nationwide, Multicenter Randomized Controlled Trial of Yoga in Cancer Survivors. [2020]Cancer-related fatigue (CRF) often co-occurs with sleep disturbance and is one of the most pervasive toxicities resulting from cancer and its treatment. We and other investigators have previously reported that yoga therapy can improve sleep quality in cancer patients and survivors. No nationwide multicenter phase III randomized controlled trial (RCT) has investigated whether yoga therapy improves CRF or whether improvements in sleep mediate the effect of yoga on CRF. We examined the effect of a standardized, 4-week, yoga therapy program (Yoga for Cancer Survivors [YOCAS]) on CRF and whether YOCAS-induced changes in sleep mediated changes in CRF among survivors.
Individualized, Single Session Yoga Therapy to Reduce Physical and Emotional Symptoms in Hospitalized Hematological Cancer Patients. [2020]Objective: Inpatient treatment of hematological cancer is among the most physically and mentally arduous cancer treatments, and it is associated with a number of common physical, emotional, and social symptoms that can negatively affect quality of life (QOL) for years following treatment. While treating symptoms during hospitalization holds promise for improving long-term QOL, successful approaches likely require multidisciplinary interventions. In this article, we describe a 4-year effort in program enhancement that incorporated an adjunctive single yoga therapy session during treatment for hematological malignancies. Methods: Hospitalized patients receiving treatment for hematological cancer (N = 486) were provided a 40-minute individualized yoga therapy session. We evaluated feasibility and acceptance by quantifying the percentage of patients who discontinued the yoga session due to pain, discomfort, or another reason, and by comparing the intervention population to the demographic makeup of the unit more generally. Patient-reported symptoms were obtained before and after each session, and we evaluated acute symptom change for the entire sample and in subsamples that are less likely to use mindfulness-based interventions such as yoga. Results: The majority of sessions (87%) were completed, and the majority of unfinished sessions were interrupted by a medical procedure or because the patient fell asleep. No session was stopped early due to patients' reported pain. Significant decreases were reported in all symptoms, with the greatest decrease in fatigue and anxiety. Conclusions: Yoga therapy was a feasible and effective nondrug adjunct intervention for hospitalized patients receiving treatment for hematological cancer, including bone marrow transplantation.
Enhancing Access to Yoga for Older Male Veterans After Cancer: Examining Beliefs About Yoga. [2022]Yoga is an effective clinical intervention for cancer survivors. Most studies of the positive effects of yoga on cancer patients report on predominantly middle-aged women with breast cancer. Less is known about the use of yoga in older adults, veterans, and those from diverse racial or ethnic backgrounds.
Sleep moderates the effects of Tibetan yoga for women with breast cancer undergoing chemotherapy. [2022]This study examined self-reported and actigraphy-assessed sleep and depression as moderators of the effect of a Tibetan yoga intervention on sleep and depression among women undergoing chemotherapy for breast cancer. This is a secondary analysis of an RCT examining a 4-session Tibetan yoga program (TYP; n = 74) versus stretching program (STP; n = 68) or usual care (UC; n = 85) on self-reported sleep (Pittsburgh Sleep Quality Index (PSQI), actigraphy-assessed sleep efficiency (SE)) and depression (Centers for Epidemiological Studies Depression Scale; CES-D) for women undergoing chemotherapy for breast cancer. Data were collected at baseline and 1-week and 3-month post-intervention. Baseline PSQI, actigraphy-SE, and CES-D were examined as moderators of the effect of group on PSQI, actigraphy-SE, and CES-D 1 week and 3 months after treatment. There was a significant baseline actigraphy-SE × group effect on PSQI at 1 week (p
Mind-body interventions in oncology. [2021]A number of mind-body interventions have been studied for use with cancer patients, primarily measuring outcomes relating to pain control, anxiety reduction, and enhancing quality of life. This chapter defines the scope and characteristics of mind-body interventions, followed by a selective review of research indicating their appropriate use or cautions in cancer care. Mind-body interventions included are hypnosis, imagery/relaxation, meditation, yoga, and creative therapies. Current evidence supports the efficacy of hypnosis and imagery/relaxation for control of pain and anxiety during cancer treatments. Meditation is supported for reductions in stress and improvements in mood, quality of life, and sleep problems. There is a growing body of support for yoga from randomized controlled trials for improving quality of life, sleep, and mood. Creative therapies such as visual arts, dance, and music may help cancer patients express their feelings and cope with the demands of a cancer experience. Research on biological marker effects of mind-body therapies remains inconclusive. Study of mind-body interventions generally requires additional, methodologically rigorous investigation of how various interventions best assist patients during various phases of cancer survivorship, although a major benefit of these therapies lies in the opportunity for patients to self-select them.