Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04185428
• Other study ID #: IRB201903226
• Status: Suspended
• Phase: N/A
• Start date: March 3, 2020
• Est. completion date: January 21, 2025

Study information

• Verified date: April 2024
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia

Intervention

Behavioral:
• Integrative Therapy
still meditation, meditative movement, relaxation techniques, and massage therapy

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

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