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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT04185428
Other study ID # IRB201903226
Secondary ID
Status Suspended
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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