Investigating Integrative Therapies for Symptom Management in Adults With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT04185428|
Recruitment Status : Suspended (Due to COVID-19)
First Posted : December 4, 2019
Last Update Posted : April 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Behavioral: Integrative Therapy||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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.|
|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 :||March 3, 2020|
|Estimated Primary Completion Date :||January 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185428
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32608|
|Principal Investigator:||Heather Janelle, MSN, RN||University of Florida|