Acute Myeloid Leukemia
Conditions
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.
Interventions
BEHAVIORALIntegrative Therapy
still meditation, meditative movement, relaxation techniques, and massage therapy
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Integrative Therapy - proportion agreeing to participate | 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 | baseline through 3 weeks | a 70% completion rate (indicated by the completion of 5 or more sessions) |
| Acceptability of Integrative Therapy | 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. |
Countries
United States
Outcome results
None listed