Acute Myeloid LeukemiaNCT04185428
Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia
A study testing Integrative Therapy in people with Acute Myeloid Leukemia, run by University of Florida at 1 site in United States.
Trial summary
This pilot study will use a mixed methods approach to evaluate the feasibility and acceptability of Integrative Therapies, a bedside service offering mindfulness-based interventions (still meditation, meditative movement, relaxation techniques, and massage therapy) as non-pharmacologic treatment for symptom management… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Integrative Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2023to 4 Mar 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to local area Bone Marrow Transplant Unit or Hematology/Oncology during the study period
- Diagnosed with acute leukemia
- Receiving high-grade MDS induction chemotherapy
- Within first 3 days of chemotherapy initiation
- Age > 18 years
- Able to speak/read English
Who cannot join
- -Altered mental status or diminished level of consciousness as established by daily progress note documented by health care provider, nursing assessment, or at the discretion of the Integrative Therapies practitioner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia Undergoing High-grade MDS Induction Chemotherapy
This pilot study will use a mixed methods approach to evaluate the feasibility and acceptability of Integrative Therapies, a bedside service offering mindfulness-based interventions (still meditation, meditative movement, relaxation techniques, and massage therapy) as non-pharmacologic treatment for symptom management in newly diagnosed adult Acute Myeloid Leukemia (AML) patients undergoing induction chemotherapy
Read the detailed description
UF Health Integrative Therapies inpatient program offers mindfulness-based interventions consisting of still meditation, meditative movement, relaxation techniques, and massage therapy to patients at the bedside. This mixed methods feasibility pilot aims to move toward optimal use of the Integrative Therapies service amongst AML patients undergoing induction chemotherapy by: 1) examining the feasibility and acceptability of this intervention and describing the distribution of variables, 2) developing a greater understanding of patient experience, and 3) exploring facilitators and barriers to engagement with the service. The investigators intend to use the data collected from this study to inform a subsequent multi-site study with a larger sample size and adjustments depending on the results from this investigation.
The study team will also explore the acceptability to participation in Integrative Therapies bedside service by conducting a qualitative, phenomenological thematic analysis of patient interviews. The intent of a convergent design is to merge the analyses of the quantitative and qualitative data that are gathered during the implementation of Integrative Therapies bedside service.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Integrative Therapy
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative TherapyBehavioural
still meditation, meditative movement, relaxation techniques, and massage therapy
| Study group | Role | What they receive |
|---|---|---|
| Standard of care with integrative therapy | Experimental | For the intervention group, an initial interview will be conducted and the Patient-Reported Outcomes Measurement Information System (PROMIS) and Memorial Symptom Assessment Scale (MSAS) questionnaires will be administered at enrollment. Integrative Therapies will then begin offering two to four sessions weekly. At 7, 14, and 21 days (+-2 days) after the start of induction chemotherapy, the PROMIS and the MSAS questionnaires will be administered again along with an acceptability questionnaire. At 21 (+-2) days after the start of induction chemotherapy, a second interview will be conducted. Receives: Behavioral: Integrative Therapy |
| Standard of care only | No intervention | For the standard care group, an initial interview will be conducted and the PROMIS and MSAS questionnaires will be administered at enrollment. At 7, 14, and 21 days (+-2 days) after the start of induction chemotherapy, the PROMIS and the MSAS questionnaires will be administered again. At 21 days (+-2 days) after the start of induction chemotherapy, a second interview will be conducted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Integrative Therapy - proportion agreeing to participate
at least 50% electing to join the intervention
Measured: baseline through 3 weeks
Feasibility of Integrative Therapy - proportion of participants who complete at least 5 sessions
a 70% completion rate (indicated by the completion of 5 or more sessions)
Measured: baseline through 3 weeks
Acceptability of Integrative Therapy
Distribution of responses to acceptability with an acceptability benchmark of at least 75% of Integrative Therapy group members "rating the program as acceptable" via the acceptability questionnaire. Likert scoring 1-5, wit h on as very low and 5 being very high.
Measured: baseline through 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start9 Aug 2023
- Primary completion4 Mar 2025
- Study completion4 Mar 2025
Why it stopped: The PIs left the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- In this feasibility pilot and qualitative interview mixed methods study, quantitative data will be used to describe the distribution of changes over time for anxiety, pain and other common symptoms among intervention and standard care groups as well as measures of feasibility and acceptability for the study design and methods.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nosha Farhadfar, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185428
- Sponsor's protocol ID
- IRB201903226
- Status last verified
- Apr 2025
- First submitted
- 2 Dec 2019
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia Undergoing High-grade MDS Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT04185428
- Acronym / sponsor ID
- IRB201903226
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The PIs left the institution.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 4 Mar 2025 (actual)
- First posted
- 4 Dec 2019 (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 pilot study will use a mixed methods approach to evaluate the feasibility and acceptability of Integrative Therapies, a bedside service offering mindfulness-based interventions (still meditation, meditative movement, relaxation techniques, and massage therapy) as non-pharmacologic treatment for symptom management in newly diagnosed adult Acute Myeloid Leukemia (AML) patients undergoing induction chemotherapy
Detailed description
UF Health Integrative Therapies inpatient program offers mindfulness-based interventions consisting of still meditation, meditative movement, relaxation techniques, and massage therapy to patients at the bedside. This mixed methods feasibility pilot aims to move toward optimal use of the Integrative Therapies service amongst AML patients undergoing induction chemotherapy by: 1) examining the feasibility and acceptability of this intervention and describing the distribution of variables, 2) developing a greater understanding of patient experience, and 3) exploring facilitators and barriers to engagement with the service. The investigators intend to use the data collected from this study to inform a subsequent multi-site study with a larger sample size and adjustments depending on the results from this investigation.
The study team will also explore the acceptability to participation in Integrative Therapies bedside service by conducting a qualitative, phenomenological thematic analysis of patient interviews. The intent of a convergent design is to merge the analyses of the quantitative and qualitative data that are gathered during the implementation of Integrative Therapies bedside service.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this feasibility pilot and qualitative interview mixed methods study, quantitative data will be used to describe the distribution of changes over time for anxiety, pain and other common symptoms among intervention and standard care groups as well as measures of feasibility and acceptability for the study design and methods.
| Arm | Type | Receives |
|---|---|---|
| Standard of care with integrative therapy | Experimental | Behavioral: Integrative TherapyFor the intervention group, an initial interview will be conducted and the Patient-Reported Outcomes Measurement Information System (PROMIS) and Memorial Symptom Assessment Scale (MSAS) questionnaires will be administered at enrollment. Integrative Therapies will then begin offering two to four sessions weekly. At 7, 14, and 21 days (+-2 days) after the start of induction chemotherapy, the PROMIS and the MSAS questionnaires will be administered again along with an acceptability questionnaire. At 21 (+-2) days after the start of induction chemotherapy, a second interview will be conducted. |
| Standard of care only | No intervention | –For the standard care group, an initial interview will be conducted and the PROMIS and MSAS questionnaires will be administered at enrollment. At 7, 14, and 21 days (+-2 days) after the start of induction chemotherapy, the PROMIS and the MSAS questionnaires will be administered again. At 21 days (+-2 days) after the start of induction chemotherapy, a second interview will be conducted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to local area Bone Marrow Transplant Unit or Hematology/Oncology during the study period
- Diagnosed with acute leukemia
- Receiving high-grade MDS induction chemotherapy
- Within first 3 days of chemotherapy initiation
- Age > 18 years
Key exclusion criteria (1 listed)
- -Altered mental status or diminished level of consciousness as established by daily progress note documented by health care provider, nursing assessment, or at the discretion of the Integrative Therapies practitioner
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 |
|---|---|---|
| Integrative Therapystill meditation, meditative movement, relaxation techniques, and massage therapy | Behavioural | Standard of care with integrative therapy |
Primary outcome
Feasibility of Integrative Therapy - proportion agreeing to participate
Time frame: baseline through 3 weeks
at least 50% electing to join the intervention
Feasibility of Integrative Therapy - proportion of participants who complete at least 5 sessions
Time frame: baseline through 3 weeks
a 70% completion rate (indicated by the completion of 5 or more sessions)
Acceptability of Integrative Therapy
Time frame: baseline through 3 weeks
Distribution of responses to acceptability with an acceptability benchmark of at least 75% of Integrative Therapy group members "rating the program as acceptable" via the acceptability questionnaire. Likert scoring 1-5, wit h on as very low and 5 being very high.
Results and safety
The study was stopped early (reason given: The PIs left the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2025.
- 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.
Nosha Farhadfar, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative Therapy in people with Acute Myeloid Leukemia, run by University of Florida 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 7 Apr 2025. 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 was stopped early (reason given: The PIs left the institution.). Results are not available in the source record.
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?
Feasibility of Integrative Therapy - proportion agreeing to participate (time frame: baseline through 3 weeks). The study lists 3 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 7 Apr 2025.