Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

Study Overview
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Brief Summary
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This research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (AML) may be affected by metabolism and how best to study this association. Symptoms include experiences like fatigue, sleep disturbance, pain, and depression.

Detailed Description
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This is a prospective, longitudinal, observational exploratory study. Ten participants will be enrolled and will complete baseline and week 4 blood sample collections. Symptom questionnaires will be completed at baseline, 1-, 2-, 3- and 4-weeks. This research study is a Pilot Study, which means it is the first time that researchers are studying the associations between symptoms and metabolism in this way. The National Institute of Nursing Research is supporting this research study by providing funding for the research study.

Official Title
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A Pilot Study to Assess Feasibility and Explore Variability in Biomarkers and Patient Reported Outcome Measures in Patients Undergoing Induction Chemotherapy for Acute Myeloid Leukemia

Conditions
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Acute Myeloid Leukemia (AML)

Intervention / Treatment
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* Other: Blood Sample Collection - Observational Study
* Other: Symptom questionnaires - Observational Study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The Cantor Center CRC will attend weekly protocol meetings in the DFCI adult leukemia center to identify eligible patients and will confirm eligibility by reviewing the electronic health record and, if needed, contacting the treating physician. Subjects enrolled in clinical trials or other studies requiring extra blood samples and/or completion of questionnaires will be discussed with their oncology care team and/or investigators of the other study teams to ensure avoidance of excess subject burden. Only subjects deemed appropriate for enrollment without adding excess burden will be approached about this study. Inclusion Criteria: Adult (18+ years old) New diagnosis of acute myeloid leukemia (AML) Admitted to the DFCI Inpatient Hospital in the BWH for intensive induction chemotherapy (e.g., 7+3 regimen) Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) ≤ 3 OR Karnofsky Performance Status (KPS) ≥ 50 Ability to comprehend and speak English Ability to provide informed consent Exclusion Criteria: Cognitive or psychiatric conditions prohibiting study consent or participation Multiple primary cancers A treating clinician reports that the subject is inappropriate for the study or that the study presents excess subject burden

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>This is a prospective, longitudinal, observational exploratory study. Ten subjects will be enrolled and will complete baseline and week 4 blood draws and symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks. | Other: Blood Sample Collection - Observational Study<br>* Blood samples will be collected at enrollment and week 4 and used in analyses to understand associations between metabolic function and symptom experiences.<br>Other: Symptom questionnaires - Observational Study<br>* Symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate | Evaluate the feasibility of conducting this type of study on an in-patient oncology unit (i.e., >70% of enrolled participants will complete 30-day outcome assessments). Using descriptive statistics, feasibility will be calculated as the percent of eligible participants who enroll in the study and among those who enroll, the percent who complete the study. Using a 90%-exact binomial confidence interval estimate, 8 out of 10 participants completing the 30-day study will be considered acceptable for feasibility | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rate | Evaluate the feasibility of conducting this type of study on an in-patient oncology unit (i.e., ≥ 50% approach-to enrollment rate of eligible participants). Using descriptive statistics, feasibility will be calculated as the percent of eligible participants who enroll in the study and among those who enroll, the percent who complete the study. Using a 90%-exact binomial confidence interval estimate, 8 out of 10 participants completing the 30-day study will be considered acceptable for feasibility | 30 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Myeloid Leukemia (AML)