Investigating Integrative Therapies for Symptom Management in Adults With Acute Leukemia

NCT04185428 | Terminated

• 1 other identifier: IRB201903226
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Behavioral: Integrative Therapy

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

Standard of care with integrative therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Nosha Farhadfar, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this feasibility pilot and qualitative interview mixed methods study, quantitative data will be used to describe the distribution of changes over time for anxiety, pain and other common symptoms among intervention and standard care groups as well as measures of feasibility and acceptability for the study design and methods.

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: December 4, 2019
• Study Start: August 9, 2023
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: April 7, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)