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Investigating Integrative Therapies for Symptom Management in Adults With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185428
Recruitment Status : Suspended (Due to COVID-19)
First Posted : December 4, 2019
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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 in newly diagnosed adult Acute Myeloid Leukemia (AML) patients undergoing induction chemotherapy

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Behavioral: Integrative Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Investigating Integrative Therapies for Symptom Management in Adults With Acute Myeloid Leukemia Undergoing Induction Chemotherapy
Actual Study Start Date : March 3, 2020
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : June 1, 2022


Arm Intervention/treatment
Experimental: Standard of care with integrative therapy
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.
Behavioral: Integrative Therapy
still meditation, meditative movement, relaxation techniques, and massage therapy

No Intervention: Standard of care only
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.



Primary Outcome Measures :
  1. Feasibility of Integrative Therapy - proportion agreeing to participate [ Time Frame: baseline through 3 weeks ]
    at least 50% electing to join the intervention

  2. 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)

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Admitted to local area Bone Marrow Transplant Unit or Hematology/Oncology during the study period
  • Newly diagnosed with acute myeloid leukemia (non-M3)
  • Receiving "7+3" induction chemotherapy
  • Within first 3 days of chemotherapy initiation
  • Able to speak/read English

Exclusion Criteria:

-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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185428


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Heather Janelle, MSN, RN University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04185428    
Other Study ID Numbers: IRB201903226
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms