Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML
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
2 other identifiers
observational
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2021
CompletedFirst Posted
Study publicly available on registry
June 1, 2021
CompletedStudy Start
First participant enrolled
July 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedApril 5, 2023
April 1, 2023
1.6 years
May 26, 2021
April 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Enrollment rate
30 Days
Study Arms (1)
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.
Interventions
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 at baseline, 1-, 2-, 3- and 4-weeks.
Eligibility Criteria
10 patients with acute myeloid leukemia (AML) admitted to Dana Farber Cancer Institute for induction chemotherapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marilyn J. Hammer, PhD, RN
Dana-Farber Cancer Institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 26, 2021
First Posted
June 1, 2021
Study Start
July 26, 2021
Primary Completion
February 23, 2023
Study Completion
February 23, 2023
Last Updated
April 5, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.