Clinical trial NCT04908852: Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia (AML)
Keywords: Acute Myeloid Leukemia (AML)
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 10 patients with acute myeloid leukemia (AML) admitted to Dana Farber Cancer Institute for induction chemotherapy

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion rate
timeFrame: 30 Days
Secondary outcomes:
measure: Enrollment rate
timeFrame: 30 Days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Marilyn J. Hammer, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: