Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

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

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

Study Overview

• Status: Suspended
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Behavioral: Integrative Therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Integrative Therapy - proportion agreeing to participate	at least 50% electing to join the intervention	baseline through 3 weeks
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
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

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Nosha Farhadfar, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2020
• Primary Completion (Estimated): January 21, 2025
• Study Completion (Estimated): January 21, 2025

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 2, 2019
• First Posted (Actual): December 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Leukemia
• Other Study ID Numbers: IRB201903226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No