Investigating Integrative Therapies for Symptom Management in Adults With Acute Myeloid Leukemia

Sponsor

University of Florida (Other)

Overall Status

Suspended

CT.gov ID

NCT04185428

Collaborator

(none)

Enrollment

Location

Arms

34.6

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Behavioral: Integrative Therapy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Investigating Integrative Therapies for Symptom Management in Adults With Acute Myeloid Leukemia Undergoing Induction Chemotherapy

Actual Study Start Date :

Mar 3, 2020

Anticipated Primary Completion Date :

Jan 21, 2023

Anticipated Study Completion Date :

Jan 21, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Standard of care with 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.	Behavioral: Integrative Therapy still meditation, meditative movement, relaxation techniques, and massage therapy
No Intervention: Standard of care only 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.

Arm

Intervention/Treatment

Experimental: Standard of care with 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.

Behavioral: Integrative Therapy

still meditation, meditative movement, relaxation techniques, and massage therapy

No Intervention: Standard of care only

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.

Outcome Measures

Primary Outcome Measures

Feasibility of Integrative Therapy - proportion agreeing to participate [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Admitted to local area Bone Marrow Transplant Unit or Hematology/Oncology during the study period
Newly diagnosed with acute myeloid leukemia (non-M3)
Receiving "7+3" induction chemotherapy
Within first 3 days of chemotherapy initiation
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida	Gainesville	Florida	United States	32608

Sponsors and Collaborators

University of Florida

Investigators

Principal Investigator: Heather Janelle, MSN, RN, University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Florida

ClinicalTrials.gov Identifier:

NCT04185428

Other Study ID Numbers:

IRB201903226

First Posted:

Dec 4, 2019

Last Update Posted:

Jan 18, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jan 18, 2022