Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

NCT ID: NCT04908852

Last Updated: 2023-04-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-07-26
• Study Completion Date: 2023-02-23

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.

Conditions

Acute Myeloid Leukemia (AML)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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.

Blood Sample Collection - Observational Study

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

Blood Sample Collection - Observational Study

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

Intervention Type: OTHER

Symptom questionnaires - Observational Study

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

Intervention Type: OTHER

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Marilyn Hammer, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilyn J. Hammer, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

N98F20P00013

Identifier Type: OTHER

Identifier Source: secondary_id

21-161

Identifier Type: -

Identifier Source: org_study_id