Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

Not Applicable

Suspended

• Conditions: Acute Myeloid Leukemia
• Interventions: Behavioral: Integrative Therapy

• Registration Number: NCT04185428
• Lead Sponsor: University of Florida

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-02
• Study First Submitted QC: 2019-12-02
• Study First Posted: 2019-12-04
• Study Start: 2020-03-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-19
• Last Update Posted: 2024-04-23
• Primary Completion: 2025-01-21
• Study Completion: 2025-01-21

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care with integrative therapy	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.

Primary Outcome Measures

Name	Time	Method
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.
Feasibility of Integrative Therapy - proportion agreeing to participate	baseline through 3 weeks	at least 50% electing to join the intervention

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States