---
title: Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia
nct_id: NCT04185428
overall_status: TERMINATED
phase: NA
sponsor: University of Florida
study_type: INTERVENTIONAL
primary_condition: Acute Myeloid Leukemia
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04185428.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04185428"
ct_last_update_post_date: 2025-04-07
last_seen_at: "2026-05-12T07:17:42.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

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

**NCT ID:** [NCT04185428](https://clinicaltrials.gov/study/NCT04185428)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** The PIs left the institution.
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 9
- **Lead Sponsor:** University of Florida
- **Conditions:** Acute Myeloid Leukemia
- **Start Date:** 2023-08-09
- **Completion Date:** 2025-03-04
- **CT.gov Last Update:** 2025-04-07

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Standard of care with integrative therapy** (EXPERIMENTAL) — 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.
- **Standard of care only** (NO_INTERVENTION) — 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.

## Interventions

- **Integrative Therapy** (BEHAVIORAL) — still meditation, meditative movement, relaxation techniques, and massage therapy

## Primary Outcomes

- **Feasibility of Integrative Therapy - proportion agreeing to participate** _(time frame: baseline through 3 weeks)_ — at least 50% electing to join the intervention
- **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.

## Locations (1)

- University of Florida, Gainesville, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of florida|gainesville|florida|united states` — added _(2026-05-12)_

---

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