Myeloproliferative NeoplasmNCT04605211
A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs or CML on Tyrosine Kinase Inhibitors
A study testing Online Mindfulness Meditation and Internet-Based Webinars in people with Myeloproliferative Neoplasm and Chronic Phase Chronic Myelogenous Leukemia, run by University of California, San Francisco at 1 site in United States.
Trial summary
This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Neoplasm, Chronic Phase Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia
- What is being tested?
- Online Mindfulness Meditation and Internet-Based Webinars
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2020to 30 Sep 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
- PATIENT: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- PATIENT: Be able to speak and read English
- PATIENT: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- PATIENT: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
- PATIENT: Be able to provide informed consent
Show all 11Show fewer
- CAREGIVER: Be a spouse/partner, other family member, or a close friend of a BCR-ABL-negative patient who consented to participate in the Being Present-MPN study
- CAREGIVER: Be able to speak and read English
- CAREGIVER: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- CAREGIVER: Have access to a mobile phone capable of receiving text messages, as determined by a study investigator
- CAREGIVER: Be able to provide informed consent
Who cannot join
- PATIENT: Have had their BCR-ABL-negative MPN transform into acute leukemia
- PATIENT: Have had their CP-CML transform into blast phase
- PATIENT: Be post-allogeneic stem cell transplantation
- PATIENT AND CAREGIVER: Have extensive hearing loss such that ability to participate in the study would be impaired
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors
This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.
Read the detailed description
PRIMARY OBJECTIVES:
- To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients.
II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on tyrosine kinase inhibitors (TKIs), and CP-CML patients in treatment-free remission (TFR).
III. To determine the acceptability of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, CP-CML patients on TKIs, CP-CML patients on TKIs, and CP-CML patients in TFR.
SECONDARY OBJECTIVE:
- To evaluate the preliminary efficacy of the intervention.
EXPLORATORY OBJECTIVES:
- To evaluate for differences in the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars:
Ia. Based on demographic or clinicopathologic factors. Ib. In patients versus caregivers.
II. To evaluate for differences in the preliminary efficacy an 8-week web-based mindfulness meditation program with live webinars:
IIa. Based on demographic or clinicopathologic factors. IIb. In BCR-ABL-negative patients versus caregivers. IIc. In BCR-ABL-negative patient-caregiver pairs versus unpaired patients. IId. Based on level of adherence to the practice instructions.
OUTLINE:
Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week.
After completion of study, patients and caregivers are followed up at 8 weeks.
- Conditions
- Myeloproliferative Neoplasm, Chronic Phase Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia
- Being tested
- Online Mindfulness Meditation, Internet-Based Webinars
- Keywords
- BCR-ABL-Negative, Distress Reduction, Tyrosine Kinase Inhibitors, Leukemia
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Mindfulness MeditationBehavioural
Also called Online MBSR, Online Mindful Meditation, Web-Based Mindfulness Meditation
Complete online audio-based mindfulness meditation exercises
Internet-Based WebinarsOther
Attend webinars
| Study group | Role | What they receive |
|---|---|---|
| Being Present (Supportive Care) | Experimental | Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week. Receives: Behavioral: Online Mindfulness Meditation; Other: Internet-Based Webinars |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Primary Symptoms
The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.
Measured: Up to 90 days
Frequency of Participants' Understanding of Hematologic Malignancies
The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.
Measured: Up to 90 days
Frequency of Participants' Perception of web-based mindfulness meditation
The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.
Measured: Up to 90 days
Frequency of Reported Barriers of Web-Based Mindfulness Meditation
The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.
Measured: Up to 90 days
Percentage of patients approached who consent to participate
Recruitment rate will be reported as a percentage of all patients who were approached by the study team or medical professional whom consented to participate in the active study.
Measured: Up to 90 days
Frequency of Reasons for Ineligibility
For potential study candidates who are ineligible, caregiver relationship and reasons for ineligibility will be collected. Reasons for ineligibility will be reported using descriptive statistics.
Measured: Up to 90 days
Frequency of Reasons for Refusal to Participate
For potential study candidates who decide not to participate, caregiver relationship and reasons for refusal will be collected. Reasons for refusal will be reported using descriptive statistics.
Measured: Up to 16 weeks
Frequency of Attrition over time
The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.
Measured: Up to 16 weeks
Frequency of Attrition Causes
Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.
Measured: Up to 16 weeks
Frequency of meditation practice
The study team will call participants and conduct a brief interview to gauge current mindfulness meditation practice. Frequency of mediation will be reported using descriptive statistics.
Measured: Up to 16 weeks
Median duration of meditation practice
The study team will call participants and conduct a brief interview to gauge current duration of mindfulness meditation practice. Duration of mediation will be reported using descriptive statistics.
Measured: Up to 16 weeks
Frequency of playing recorded webinars
The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Measured: Up to 16 weeks
Duration of playing recorded webinars
The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Measured: Up to 16 weeks
Measure of Acceptability using semi-structured interviews
Information about acceptability and the overall intervention experience will come from semi-structured interviews. Audio recordings of the semi-structured interviews will be professionally transcribed and coded using Atlas.ti for categorizing acceptability using qualitative thematic analysis by at least two investigators.
Measured: Up to 16 weeks
Secondary outcomes (7)
Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores
This single-item inventory uses an analog graphic to allow patients to assess their overall distress with a score range of 0 (no distress) to 10 (extreme distress). A score of 4 or higher to differentiate clinically significant distress. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
The PROMIS anxiety scale is a 8 item scale which measures a participants anxiety based on their response to anxiety related items. Each item response ranges from 1 (never) to 5 (always)Paired t-tests will compare validated survey results. Raw scores ranging from 8 - 40 are converted to scaled scores to determine a standardized anxiety score with higher scores indicating a greater anxiety. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
The EORTC QLQ-C30 has been developed as a quantitative measure of health-related quality of life for use in clinical trials of cancer patients. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
The MPN-SAF TSS is 10-item questionnaire is recommended in the NCCN Guidelines for the assessment of symptom burden at baseline and monitoring symptom status during the course of treatment with individual item scores ranging from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)
The EORTC QLQ-CML24 assessment consists of 24 items measuring the following aspects: Symptom Burden, Impact on Daily Life, Impact on Worry/Mood, Body Image Problems, Satisfaction with Care and Satisfaction with Social Life. This scale includes 24 items with responses ranging from a score of 0 (not at all) to 4 (very much). Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC)
The CQOLC is a self-administered scale specifically designed to evaluate cancer patient caregiver quality of life. This scale includes 35 items with responses ranging from a score of 0 (not at all) to 4 (very much). The total possible score is 140, with higher scores representing better quality of life. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
The FFMQ-SF assessment measures five facets of mindfulness: Observing, Describing, Acting with Awareness, Non-Judging of inner experience, and Non-Reactivity to inner experience. The score of each facet is computed by summing the 3 items assigned to the facet which asks the individual to rate which response represents your own opinion of what is generally true for you. Each statement (item) has scores ranging from 1 (never or very rarely true) to 5 (very often or always true), for a total of 15 points per facet. Paired t-tests will compare validated survey results.
Measured: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start18 Sep 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Society of Hematology
- Responsible party
- Sponsor
- Investigators
- Kelly Schoenbeck, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605211
- Sponsor's protocol ID
- 202510
- Other IDs
- NCI-2020-07364
- Status last verified
- Feb 2023
- First submitted
- 21 Oct 2020
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Being Present-MPN: A Distress Reduction Intervention for Patients With BCR-ABL-Negative MPNs and CML on Tyrosine Kinase Inhibitors
- ClinicalTrials.gov ID
- NCT04605211
- Acronym / sponsor ID
- 202510
- Conditions
- Myeloproliferative Neoplasm, Chronic Phase Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia
- Keywords
- BCR-ABL-Negative, Distress Reduction, Tyrosine Kinase Inhibitors, Leukemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Society of Hematology
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 27 Oct 2020 (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.
This trial looks at how well a distress reduction intervention, called "Being Present", works to improve the quality of life of patients with BCR-ABL-negative myeloproliferative neoplasms (MPNs) or chronic phase chronic myeloid leukemia (CP-CML) who are taking tyrosine kinase inhibitors (TKIs) and their caregivers. Mindfulness meditation is the practice of repeatedly bringing attention back to the immediate experience and may help people cope with various types of illness, stress, and worry. This may help patients and caregivers to gradually learn to disconnect from reacting to and dwelling on the past and future and instead fully experiencing the present moment.
Detailed description
PRIMARY OBJECTIVES:
- To tailor the Being Present intervention to BCR-ABL-negative MPN and CP-CML patients.
II. To determine the feasibility of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, and CP-CML patients on tyrosine kinase inhibitors (TKIs), and CP-CML patients in treatment-free remission (TFR).
III. To determine the acceptability of an 8-week web-based mindfulness meditation program with live webinars among BCR-ABL-negative MPN patients and their caregivers, CP-CML patients on TKIs, CP-CML patients on TKIs, and CP-CML patients in TFR.
SECONDARY OBJECTIVE:
- To evaluate the preliminary efficacy of the intervention.
EXPLORATORY OBJECTIVES:
- To evaluate for differences in the feasibility and acceptability of an 8-week web-based mindfulness meditation program with live webinars:
Ia. Based on demographic or clinicopathologic factors. Ib. In patients versus caregivers.
II. To evaluate for differences in the preliminary efficacy an 8-week web-based mindfulness meditation program with live webinars:
IIa. Based on demographic or clinicopathologic factors. IIb. In BCR-ABL-negative patients versus caregivers. IIc. In BCR-ABL-negative patient-caregiver pairs versus unpaired patients. IId. Based on level of adherence to the practice instructions.
OUTLINE:
Patients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week.
After completion of study, patients and caregivers are followed up at 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Being Present (Supportive Care) | Experimental | Behavioral: Online Mindfulness Meditation, Other: Internet-Based WebinarsPatients and caregivers receive Being Present intervention consisting of online audio-based mindfulness meditation exercise over 15 minutes at least 5 times per week, daily meditation reminders, and online webinars over 30-60 minutes every week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- PATIENT: Carry a diagnosis of BCR-ABL-negative MPN or CML
- PATIENT: Have an estimated life expectancy of at least 6 months, assessed by principal investigator or treating investigator
- PATIENT: Be able to speak and read English
- PATIENT: Be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet (assessed by participant self-report)
- PATIENT: Have daily access to a mobile phone capable of receiving text messages, as determined by a study investigator
Key exclusion criteria (4 listed)
- PATIENT: Have had their BCR-ABL-negative MPN transform into acute leukemia
- PATIENT: Have had their CP-CML transform into blast phase
- PATIENT: Be post-allogeneic stem cell transplantation
- PATIENT AND CAREGIVER: Have extensive hearing loss such that ability to participate in the study would be impaired
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 Mindfulness MeditationAlso: Online MBSR, Online Mindful Meditation, Web-Based Mindfulness MeditationComplete online audio-based mindfulness meditation exercises | Behavioural | Being Present (Supportive Care) |
| Internet-Based WebinarsAttend webinars | Other | Being Present (Supportive Care) |
Primary outcome
Frequency of Primary Symptoms
Time frame: Up to 90 days
The frequency of primary symptoms will be categorized and assessed by semi-structured qualitative interviews.
Frequency of Participants' Understanding of Hematologic Malignancies
Time frame: Up to 90 days
The frequency and categorization of participants' understanding of hematologic malignancies will be assessed by semi-structured qualitative interviews.
Frequency of Participants' Perception of web-based mindfulness meditation
Time frame: Up to 90 days
The frequency and categorization of participants' perception of web-based mediation will be assessed by semi-structured qualitative interviews.
Frequency of Reported Barriers of Web-Based Mindfulness Meditation
Time frame: Up to 90 days
The frequency and categorization of participants' reported barriers to web-based mediation will be assessed by semi-structured qualitative interviews.
Percentage of patients approached who consent to participate
Time frame: Up to 90 days
Recruitment rate will be reported as a percentage of all patients who were approached by the study team or medical professional whom consented to participate in the active study.
Frequency of Reasons for Ineligibility
Time frame: Up to 90 days
For potential study candidates who are ineligible, caregiver relationship and reasons for ineligibility will be collected. Reasons for ineligibility will be reported using descriptive statistics.
Frequency of Reasons for Refusal to Participate
Time frame: Up to 16 weeks
For potential study candidates who decide not to participate, caregiver relationship and reasons for refusal will be collected. Reasons for refusal will be reported using descriptive statistics.
Frequency of Attrition over time
Time frame: Up to 16 weeks
The number of participants who attend the web-based sessions will be recorded via a roll-call and recorded at each study visit.
Frequency of Attrition Causes
Time frame: Up to 16 weeks
Reasons for not attending the web-based interventions will be recorded and characterized. Reasons for attrition will be reported using descriptive statistics.
Frequency of meditation practice
Time frame: Up to 16 weeks
The study team will call participants and conduct a brief interview to gauge current mindfulness meditation practice. Frequency of mediation will be reported using descriptive statistics.
Median duration of meditation practice
Time frame: Up to 16 weeks
The study team will call participants and conduct a brief interview to gauge current duration of mindfulness meditation practice. Duration of mediation will be reported using descriptive statistics.
Frequency of playing recorded webinars
Time frame: Up to 16 weeks
The frequency in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Duration of playing recorded webinars
Time frame: Up to 16 weeks
The duration in which participants utilize the recorded webinars will be captured via website data and will be reported using descriptive statistics
Measure of Acceptability using semi-structured interviews
Time frame: Up to 16 weeks
Information about acceptability and the overall intervention experience will come from semi-structured interviews. Audio recordings of the semi-structured interviews will be professionally transcribed and coded using Atlas.ti for categorizing acceptability using qualitative thematic analysis by at least two investigators.
7 secondary outcomes
Mean change in scores on the National Comprehensive Cancer Network (NCCN) Distress Thermometer scores
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS)
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-CML24)
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Caregiver Quality of Life Index - Cancer (CQOLC)
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
Mean change in scores on the Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: Baseline, 4 weeks, and 8 weeks, Up to 8 weeks total
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 13 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Kelly Schoenbeck, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Mindfulness Meditation and Internet-Based Webinars in people with Myeloproliferative Neoplasm and Chronic Phase Chronic Myelogenous Leukemia, run by University of California, San Francisco at 1 site in United States.
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 11 inclusion and 4 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 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Frequency of Primary Symptoms (time frame: Up to 90 days). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.