Acute Myeloid Leukemia Clinical Trial
Official title:
Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia Undergoing High-grade MDS Induction Chemotherapy
Verified date | April 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Suspended |
Enrollment | 60 |
Est. completion date | January 21, 2025 |
Est. primary completion date | January 21, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Integrative Therapy - proportion agreeing to participate | at least 50% electing to join the intervention | baseline through 3 weeks | |
Primary | 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) | baseline through 3 weeks | |
Primary | 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. | baseline through 3 weeks |
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