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NCT Number: NCT04908852

Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

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.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Sample Collection - Observational Study

Other

Blood samples will be collected at enrollment and week 4 and used in analyses to understand associations between metabolic function and symptom experiences.

Symptom questionnaires - Observational Study

Other

Symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks.

Primary outcomes

  1. Completion rate

    Time frame: 30 Days

    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

Secondary outcomes

  1. Enrollment rate

    Time frame: 30 Days

    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

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2021
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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