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Clinical Trials/NCT04185428
NCT04185428
Terminated
N/A

Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia Undergoing High-grade MDS Induction Chemotherapy

University of Florida1 site in 1 country9 target enrollmentAugust 9, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Myeloid Leukemia
Sponsor
University of Florida
Enrollment
9
Locations
1
Primary Endpoint
Feasibility of Integrative Therapy - proportion of participants who complete at least 5 sessions
Status
Terminated
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 9, 2023
End Date
March 4, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Feasibility of Integrative Therapy - proportion agreeing to participate

Time Frame: baseline through 3 weeks

at least 50% electing to join the intervention

Study Sites (1)

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