Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

  • STATUS
    Recruiting
  • End date
    Aug 31, 2022
  • participants needed
    10
  • sponsor
    Dana-Farber Cancer Institute
Updated on 3 August 2021
induction chemotherapy

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.

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.

Details
Condition Acute myeloid leukemia, acute myelogenous leukemia, anll, acute myeloblastic leukemia
Treatment Blood Sample Collection - Observational Study, Symptom questionnaires - Observational Study
Clinical Study IdentifierNCT04908852
SponsorDana-Farber Cancer Institute
Last Modified on3 August 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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