Quality of LifeNCT03503838
A Pilot Study of Online Yoga for MPN Patients
A study testing Online Yoga in people with Quality of Life and Cancer, run by Arizona State University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Quality of Life, Cancer
- What is being tested?
- Online Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 23 Sep 2016to 12 Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
About this study
Official title: A Pilot Study of Online Yoga to Improve Symptom Burden (i.e., Fatigue) and Quality of Life in MPN Patients
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).
Read the detailed description
Participants will be recruited nationally utilizing internet-based strategies, including social media (i.e., Facebook, Twitter), social networking sites, online and email listervs, and by contacting MPN patients that were not included in prior feasibility work but expressed their interest in future work. The research team will provide flyers to recruitment contacts to provide a description of the study.
MPN patients that expressed interest in future studies will be contacted via email to be asked of their interest in the current study. A flyer will be provided in the email. Prospective organizations will be contacted via email and/or phone and asked to advertise the study by posting the provided recruitment information (e.g., flyers, blurbs) to social media sites and/or websites, emailing listservs, or displaying flyers at location. National organizations agreeing to advertise for the study will be sent recruitment information (e.g., flyers, blurbs) via email, and local organizations will have the option for hand delivery or email. Interested MPN patients will complete an eligibility screening using a Qualtrics link. The eligibility screening takes 5-10 minutes to complete.
If ineligible, the participant will be sent an email notification and will be offered a discounted monthly membership to online yoga streaming (Udaya.com). If eligible, the potential participant will be emailed to schedule a time for an intake appointment. The intake appointment will provide greater details pertaining to the study, review of the consent process, and address participant questions.
After completing the intake appointment, the participant will be directed to an informed consent page (individual link using Qualtrics) with details concerning the requirements of the study, as well as potential risks and benefits. There will be a place for the participant to type in their electronic signature, which will constitute their consent to participate in the study. After receipt of the signed consent form, the participant will be mailed a Fitbit. They will be instructed to wear the Fitbit for one week to collect baseline physical activity. After one week of wear, the participant will be directed to a Qualtrics link to complete baseline self-report measures. At this point, the participant will be randomized into either the wait-list control group or the yoga group via a web-based randomization tool.
Yoga Group: 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). A 12-week yoga prescription utilized in prior feasibility work will be improved and modified for this study. The 12-week yoga prescription was designed to be safe and progressive for this specific population. Modifications to the prescription will be made based on qualitative feedback received from patients that participated in prior feasibility work. During the intervention, all classes will offer alternative poses, modifications, and use of props (i.e., yoga blocks and straps) in the instance poses are difficult for the participant (i.e., painful, irregular, uneven breath) and to ensure safety. In addition to specific instruction regarding form and safety, the yoga therapist will provide descriptions of each video that includes tips and modifications to poses (e.g., set the knee on your yoga mat if this feels more comfortable for you). Additionally, patients will also receive a yoga modifications handout outlining the contraindicated yoga poses with modifications. This handout will include an exercise warning for patients that experience dizziness, lightheadedness or faintness, excessive shortness of breath, chest pain, and that they need to stop the activity and contact their health care professional immediately if these symptoms are experienced.
Wait-List Control Group: 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.
- Conditions
- Quality of Life, Cancer
- Being tested
- Online Yoga
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online YogaBehavioural
12 weeks of online yoga; 60 min/week
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Symptom Burden
A 10-item, validated form that calculates total symptom burden score (MPN Symptom Assessment Form Total Symptom Score)
Measured: 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
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Change in Anxiety
NIH PROMIS Anxiety Short Form
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Change in Depression
NIH PROMIS Depression Adult Short Form
Measured: 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
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Change in Sexual Function
NIH PROMIS Sexual Function
Measured: 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
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Change in Global Health
NIH PROMIS Global Health
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Secondary outcomes (1)
Change in Inflammatory Cytokine Profile
IL-6, TNF-a as measured in blood samples from study participants
Measured: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start23 Sep 2016
- Primary completion12 Jun 2017
- Study completion12 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group with a wait-list control group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Principal investigator, Jennifer Huberty, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503838
- Sponsor's protocol ID
- STUDY00004303
- Status last verified
- Feb 2022
- First submitted
- 6 Apr 2018
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified participant data will be shared with researchers upon reasonable request.
Publications
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.
PubMed 31174535
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Online Yoga to Improve Symptom Burden (i.e., Fatigue) and Quality of Life in MPN Patients
- ClinicalTrials.gov ID
- NCT03503838
- Acronym / sponsor ID
- STUDY00004303
- Conditions
- Quality of Life, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 12 Jun 2017 (actual)
- Study completion
- 12 Jun 2017 (actual)
- First posted
- 20 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Participants will be recruited nationally utilizing internet-based strategies, including social media (i.e., Facebook, Twitter), social networking sites, online and email listervs, and by contacting MPN patients that were not included in prior feasibility work but expressed their interest in future work. The research team will provide flyers to recruitment contacts to provide a description of the study.
MPN patients that expressed interest in future studies will be contacted via email to be asked of their interest in the current study. A flyer will be provided in the email. Prospective organizations will be contacted via email and/or phone and asked to advertise the study by posting the provided recruitment information (e.g., flyers, blurbs) to social media sites and/or websites, emailing listservs, or displaying flyers at location. National organizations agreeing to advertise for the study will be sent recruitment information (e.g., flyers, blurbs) via email, and local organizations will have the option for hand delivery or email. Interested MPN patients will complete an eligibility screening using a Qualtrics link. The eligibility screening takes 5-10 minutes to complete.
If ineligible, the participant will be sent an email notification and will be offered a discounted monthly membership to online yoga streaming (Udaya.com). If eligible, the potential participant will be emailed to schedule a time for an intake appointment. The intake appointment will provide greater details pertaining to the study, review of the consent process, and address participant questions.
After completing the intake appointment, the participant will be directed to an informed consent page (individual link using Qualtrics) with details concerning the requirements of the study, as well as potential risks and benefits. There will be a place for the participant to type in their electronic signature, which will constitute their consent to participate in the study. After receipt of the signed consent form, the participant will be mailed a Fitbit. They will be instructed to wear the Fitbit for one week to collect baseline physical activity. After one week of wear, the participant will be directed to a Qualtrics link to complete baseline self-report measures. At this point, the participant will be randomized into either the wait-list control group or the yoga group via a web-based randomization tool.
Yoga Group: 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). A 12-week yoga prescription utilized in prior feasibility work will be improved and modified for this study. The 12-week yoga prescription was designed to be safe and progressive for this specific population. Modifications to the prescription will be made based on qualitative feedback received from patients that participated in prior feasibility work. During the intervention, all classes will offer alternative poses, modifications, and use of props (i.e., yoga blocks and straps) in the instance poses are difficult for the participant (i.e., painful, irregular, uneven breath) and to ensure safety. In addition to specific instruction regarding form and safety, the yoga therapist will provide descriptions of each video that includes tips and modifications to poses (e.g., set the knee on your yoga mat if this feels more comfortable for you). Additionally, patients will also receive a yoga modifications handout outlining the contraindicated yoga poses with modifications. This handout will include an exercise warning for patients that experience dizziness, lightheadedness or faintness, excessive shortness of breath, chest pain, and that they need to stop the activity and contact their health care professional immediately if these symptoms are experienced.
Wait-List Control Group: 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group with a wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Online Yoga | Experimental | Behavioral: Online YogaThe 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Yoga12 weeks of online yoga; 60 min/week | Behavioural | Online Yoga |
Primary outcome
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)
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
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
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
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
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
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
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
1 secondary outcome
Change in Inflammatory Cytokine Profile
Time frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Derived from this study: PubMed 31174535Huberty 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.
- Individual participant dataSharing planned: Undecided. De-identified participant data will be shared with researchers upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Online Yoga in people with Quality of Life and Cancer, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Total Symptom Burden (time frame: Change from baseline to week 12 and change from baseline to week 16 (follow-up)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03503838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2022.