Clinical trial NCT04185428: Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia
Official title: Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia Undergoing High-grade MDS Induction Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Myeloid Leukemia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: Inclusion Criteria:

* 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

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

Primary outcomes:
measure: Feasibility of Integrative Therapy - proportion agreeing to participate
timeFrame: baseline through 3 weeks
measure: Feasibility of Integrative Therapy - proportion of participants who complete at least 5 sessions
timeFrame: baseline through 3 weeks
measure: Acceptability of Integrative Therapy
timeFrame: baseline through 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Nosha Farhadfar, MD
role: PRINCIPAL_INVESTIGATOR
References: