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A Pilot Study of Online Yoga for MPN Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503838
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Mayo Clinic
Information provided by (Responsible Party):
Jennifer Huberty, Arizona State University

Brief Summary:

Polycythemia vera (PV), essential thrombocytosis (ET), and myelofibrosis (MF) are chronic Philadelphia negative myeloproliferative neoplasms (MPNs) that are characterized by clonal proliferation of hematopoietic stem cells, intramedullary fibrosis, and splenomegaly. While disease manifestations may vary amongst the spectrum of MPNs, quality of life considerations including fatigue, concentration difficulties, pain, sleep disturbance, and depression are negatively affected in most MPN patients. Inflammation has been suggested to be involved in the development of disease-related symptoms. Specific pro-inflammatory cytokines (e.g., IL-1, IL-6, IL-8, and TNF-α) have been associated with particular patient-reported symptoms, including fatigue, abdominal complaints, microvascular symptoms, and constitutional symptoms. Pharmacologic therapy can positively impact MPN related symptoms, specifically with JAK inhibition, however, these treatments often come with negative side effects (e.g., anemia, thrombocytopenia). Much opportunity remains for improving MPN symptoms (i.e., fatigue, insomnia, loss of muscle mass, and debilitation) and quality of life.

Yoga, a gentle form of meditative exercise, has been shown to improve symptom management and quality of life parameters in cancer patients and may be effective in improving MPN-related symptoms. Here we propose a study evaluating the efficacy of an online yoga intervention comparing a yoga group to a wait-list control group for improving symptom burden and quality of life in MPN patients. Secondarily, we plan to evaluate the feasibility of collecting potential biomarkers that are related to MPN disease-related activity, such as fatigue (i.e., cortisol and serum cytokines).


Condition or disease Intervention/treatment Phase
Quality of Life Cancer Behavioral: Online Yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention group with a wait-list control group
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Online Yoga to Improve Symptom Burden (i.e., Fatigue) and Quality of Life in MPN Patients
Actual Study Start Date : September 23, 2016
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : June 12, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Online Yoga
The intervention will be 12 weeks in duration and will consist of a series of pre-approved online yoga classes. MPN patients will be asked to complete a minimum of 60 minutes per week of yoga practice with encouragement to do more if they can. All Udaya.com videos will include a proper warm-up, cool down, and closing mindfulness activity (i.e., message from yoga therapist, brief meditation, final relaxation). Qualified Udaya yoga instructors who collectively have over 200 years of training and experience will expertly instruct the online yoga classes.
Behavioral: Online Yoga
12 weeks of online yoga; 60 min/week

No Intervention: Wait-List Control
The control group will be asked to maintain their usual level of activity for 16 weeks before being given access to the yoga intervention. Once study participants in the yoga group have completed all outcome measures up through the 4-week follow-up (week 16), participants in the control group will be allowed to participate in the same online yoga prescription that was provided to the yoga group.



Primary Outcome Measures :
  1. Change in Total Symptom Burden [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    A 10-item, validated form that calculates total symptom burden score (MPN Symptom Assessment Form Total Symptom Score)

  2. Change in Fatigue [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    A single-item fatigue question taken from the MPN Symptom Assessment Form

  3. Change in Anxiety [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Anxiety Short Form

  4. Change in Depression [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Depression Adult Short Form

  5. Change in Sleep Disturbance [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Sleep Disturbance Adult Short Form

  6. Change in Sexual Function [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Sexual Function

  7. Change in Pain Intensity [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Pain Intensity Adult Short Form

  8. Change in Global Health [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    NIH PROMIS Global Health


Secondary Outcome Measures :
  1. Change in Inflammatory Cytokine Profile [ Time Frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up) ]
    IL-6, TNF-a as measured in blood samples from study participants



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1) have a diagnosis of essential thrombocytosis, polycythemia vera, or myelofibrosis identified by treating physician, 2) answer "no" to all items on the Physical Activity Readiness Questionnaire (PAR-Q), or be willing to obtain a signed medical release from their physician in the case that a question is answered with a "yes", 3) have access to a desktop or laptop on a regular basis, 4) have access to reliable internet, 5) read and understand English, 6) age 18 years or older, 7) willing to be randomized to a yoga group or a wait-list control group, and 8) willing to drive to the nearest Patient Service Center in order to receive a blood draw

Exclusion Criteria:

1) Currently perform Tai Chi, Qi Gong, or Yoga at least 60 min or more weekly, 2) currently engage in ≥150 min/week of moderate-/vigorous-intensity physical activity on a weekly basis, 3) have a history of syncope in last 2 months, 4) have a history of recurrent falls (≥2 in 2 months), 5) have a score of ≥15 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderate-severe levels of depression, 6) have an Eastern Cooperative Oncology Group 3 (ECOG 3) questionnaire score greater than three, 7) currently utilize Udaya.com, 8) currently pregnant, or 9) currently reside outside of the United States of America

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jennifer Huberty, Associate Professor, Arizona State University
ClinicalTrials.gov Identifier: NCT03503838    
Other Study ID Numbers: STUDY00004303
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified participant data will be shared with researchers upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No