A Pilot Study of Online Yoga for MPN Patients

NCT03503838 | Completed

• 1 other identifier: STUDY00004303
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Quality of Life; Cancer

Outcome Measures

Primary Outcomes (8)

• Change in Total Symptom Burden

  A 10-item, validated form that calculates total symptom burden score (MPN Symptom Assessment Form Total Symptom Score)

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Fatigue

  A single-item fatigue question taken from the MPN Symptom Assessment Form

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Anxiety

  NIH PROMIS Anxiety Short Form

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Depression

  NIH PROMIS Depression Adult Short Form

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Sleep Disturbance

  NIH PROMIS Sleep Disturbance Adult Short Form

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Sexual Function

  NIH PROMIS Sexual Function

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Pain Intensity

  NIH PROMIS Pain Intensity Adult Short Form

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

• Change in Global Health

  NIH PROMIS Global Health

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

Secondary Outcomes (1)

• Change in Inflammatory Cytokine Profile

  Change from baseline to week 12 and change from baseline to week 16 (follow-up)

Study Arms (2)

Online Yoga

EXPERIMENTAL

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

Wait-List Control

NO INTERVENTION

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.

Interventions

Online Yoga BEHAVIORAL

12 weeks of online yoga; 60 min/week

Online Yoga

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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

You may not qualify if:

• \) 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

Sponsors & Collaborators

• Arizona State University: lead
• Mayo Clinic: collaborator

Related Publications (1)

• Huberty J, Eckert R, Dueck A, Kosiorek H, Larkey L, Gowin K, Mesa R. Online yoga in myeloproliferative neoplasm patients: results of a randomized pilot trial to inform future research. BMC Complement Altern Med. 2019 Jun 7;19(1):121. doi: 10.1186/s12906-019-2530-8.

  PMID: 31174535 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Intervention group with a wait-list control group

Study Record Dates

• First Submitted: April 6, 2018
• First Posted: April 20, 2018
• Study Start: September 23, 2016
• Primary Completion: June 12, 2017
• Study Completion: June 12, 2017
• Last Updated: February 25, 2022

Record last verified: 2022-02