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DEVELOPMENT AND DESIGN OF A RANDOMIZED CONTROLLED TRIAL USING ONLINE YOGA FOR SYMPTOM MANAGEMENT IN MYELOPROLIFERATIVE NEOPLASM PATIENTS
Author(s): ,
Jennifer Huberty
Affiliations:
School of Nutrition and Health Promotion,Arizona State University,Phoenix,United States
,
Ryan Eckert
Affiliations:
School of Nutrition and Health Promotion,Arizona State University,Phoenix,United States
,
Krisstina Gowin
Affiliations:
Mayo Clinic,Phoenix,United States
,
Brenda Ginos
Affiliations:
Mayo Clinic,Phoenix,United States
,
Heidi Kosiorek
Affiliations:
Mayo Clinic,Phoenix,United States
,
Amylou Dueck
Affiliations:
Mayo Clinic,Phoenix,United States
,
Linda Larkey
Affiliations:
College of Nursing and Health Innovation,Arizona State University,Phoenix,United States
Ruben Mesa
Affiliations:
Mayo Clinic,Phoenix,United States
(Abstract release date: 05/18/17) EHA Library. Huberty J. 05/18/17; 182764; PB2050
Prof. Jennifer Huberty
Prof. Jennifer Huberty
Contributions
Abstract

Abstract: PB2050

Type: Publication Only

Background
Patients with myeloproliferative neoplasms (MPNs) suffer from symptom burdens (i.e. fatigue, weight loss, night sweats, insomnia, sexual dysfunction, and pruritus) often not alleviated by JAK inhibition. We previously demonstrated feasibility of an online, home-based yoga 12 week intervention, in MPN patients on stable medical therapy. Specifically, online yoga was feasible in MPN patients (N=38) (i.e., 68% satisfied with study, 75% felt it was helpful for symptom management and weekly yoga participation averaged ~51 min/week) and effective to alleviate residual MPN symptom burden (effect size [ES]=-0.36, p=0.004), anxiety (ES=-0.67, p=0.002), depression (ES=-0.41, p=0.049), sleep (ES=-0.58, p<0.001), and fatigue (ES=-0.33, p=0.04).

Aims
To conduct a randomized controlled pilot study further investigating the preliminary effects of online streamed yoga to improve MPN patient symptom burden compared to a wait-list control and to determine the feasibility (i.e., implementation, practicality) of collecting biomarkers that are potentially related to MPN symptoms and disease (i.e. inflammatory cytokines and cortisol) in a national study. The study is underway with early feasibility data reported herein; efficacy results to be reported at conference upon study completion.

Methods
MPN patients (on stable medications including JAK inhibition) were recruited (via online MPN organizations) and randomized to a yoga group (intervention - 12 weeks, 60min/week at Udaya.com) or wait-list control (usual care). The yoga “intervention” was developed with MPN-specific concerns in mind (i.e., enlarged spleen/liver, older adult population) and based on feedback received from our feasibility study. Weeks 1-2 were introductory (5-6, 5-10 min videos), with weeks 3-12 progressing in video duration and intensity (2-3, 20-30 min videos). All participants completed weekly activity logs, symptom burden questionnaires (MPN-SAF TSS and NIH PROMIS) at weeks 0,7,12, and 16 (follow-up), and wore a Fitbit Flex (objective activity and sleep monitor) through week 12. The yoga group only was also asked to receive a blood draw (i.e., CBC, TNF-a, IL-6) and to provide saliva samples (i.e., salivary cortisol) at baseline and will be expected to do so at post-intervention. Control group participants are asked to maintain usual levels of activity and will have access to the same videos as the yoga group after follow-up (week 16).

Results
A total of 260 MPN patients completed the eligibility questionnaire, of which 96 were eligible. Of those, the first 62 eligible were enrolled into the study (completed an informed consent). Thirty-four participants were randomized to the intervention group and 28 to the control group. Of those enrolled (n=62), 31% were diagnosed with PV (n=19), 37% with ET (n=23), and 32% with MF. The mean age of participants is 57.8 years (±10.3), 87% female (n=54), 95% Caucasian (n=59), and the mean BMI is 26.8 kg/m2. A total of 85% (n=29/34) of yoga group participants completed the baseline blood draw and 83% (n=15/18 eligible for saliva samples) completed the baseline saliva sample. Of those that completed their blood draw (distance travelled to receive blood draw ranged from 1.2 miles – 91.6 miles, avg. 16.3 miles). To date, seven participants have dropped out of the study due to: 1) study too time consuming/laborious (n=1), 2) Fitbit device being too difficult to use/wear (n=1), 3) non-study personal issue (n=2), or 4) never responding after completing the informed consent (n=2). Outcomes will be complete by May 8, 2017 with results to be presented at EHA.

Conclusion
Data presented here will inform next steps for a RCT investigating the effectiveness of online yoga for symptom management in MPN patients.

Session topic: 16. Myeloproliferative neoplasms - Clinical

Keyword(s): Treatment, Myeloproliferative disorder, Health care, Cancer

Abstract: PB2050

Type: Publication Only

Background
Patients with myeloproliferative neoplasms (MPNs) suffer from symptom burdens (i.e. fatigue, weight loss, night sweats, insomnia, sexual dysfunction, and pruritus) often not alleviated by JAK inhibition. We previously demonstrated feasibility of an online, home-based yoga 12 week intervention, in MPN patients on stable medical therapy. Specifically, online yoga was feasible in MPN patients (N=38) (i.e., 68% satisfied with study, 75% felt it was helpful for symptom management and weekly yoga participation averaged ~51 min/week) and effective to alleviate residual MPN symptom burden (effect size [ES]=-0.36, p=0.004), anxiety (ES=-0.67, p=0.002), depression (ES=-0.41, p=0.049), sleep (ES=-0.58, p<0.001), and fatigue (ES=-0.33, p=0.04).

Aims
To conduct a randomized controlled pilot study further investigating the preliminary effects of online streamed yoga to improve MPN patient symptom burden compared to a wait-list control and to determine the feasibility (i.e., implementation, practicality) of collecting biomarkers that are potentially related to MPN symptoms and disease (i.e. inflammatory cytokines and cortisol) in a national study. The study is underway with early feasibility data reported herein; efficacy results to be reported at conference upon study completion.

Methods
MPN patients (on stable medications including JAK inhibition) were recruited (via online MPN organizations) and randomized to a yoga group (intervention - 12 weeks, 60min/week at Udaya.com) or wait-list control (usual care). The yoga “intervention” was developed with MPN-specific concerns in mind (i.e., enlarged spleen/liver, older adult population) and based on feedback received from our feasibility study. Weeks 1-2 were introductory (5-6, 5-10 min videos), with weeks 3-12 progressing in video duration and intensity (2-3, 20-30 min videos). All participants completed weekly activity logs, symptom burden questionnaires (MPN-SAF TSS and NIH PROMIS) at weeks 0,7,12, and 16 (follow-up), and wore a Fitbit Flex (objective activity and sleep monitor) through week 12. The yoga group only was also asked to receive a blood draw (i.e., CBC, TNF-a, IL-6) and to provide saliva samples (i.e., salivary cortisol) at baseline and will be expected to do so at post-intervention. Control group participants are asked to maintain usual levels of activity and will have access to the same videos as the yoga group after follow-up (week 16).

Results
A total of 260 MPN patients completed the eligibility questionnaire, of which 96 were eligible. Of those, the first 62 eligible were enrolled into the study (completed an informed consent). Thirty-four participants were randomized to the intervention group and 28 to the control group. Of those enrolled (n=62), 31% were diagnosed with PV (n=19), 37% with ET (n=23), and 32% with MF. The mean age of participants is 57.8 years (±10.3), 87% female (n=54), 95% Caucasian (n=59), and the mean BMI is 26.8 kg/m2. A total of 85% (n=29/34) of yoga group participants completed the baseline blood draw and 83% (n=15/18 eligible for saliva samples) completed the baseline saliva sample. Of those that completed their blood draw (distance travelled to receive blood draw ranged from 1.2 miles – 91.6 miles, avg. 16.3 miles). To date, seven participants have dropped out of the study due to: 1) study too time consuming/laborious (n=1), 2) Fitbit device being too difficult to use/wear (n=1), 3) non-study personal issue (n=2), or 4) never responding after completing the informed consent (n=2). Outcomes will be complete by May 8, 2017 with results to be presented at EHA.

Conclusion
Data presented here will inform next steps for a RCT investigating the effectiveness of online yoga for symptom management in MPN patients.

Session topic: 16. Myeloproliferative neoplasms - Clinical

Keyword(s): Treatment, Myeloproliferative disorder, Health care, Cancer

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