NCT06795139

Brief Summary

The goal of this study is to test the feasibility of a data visualization tool called the Trial Enrollment Diversity Dashboard (TEDD) to ensure participant diversity in acute leukemia trial enrollment.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable leukemia

Timeline
14mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Mar 2025Jun 2027

First Submitted

Initial submission to the registry

January 22, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1.3 years

First QC Date

January 22, 2025

Last Update Submit

August 22, 2025

Conditions

Keywords

LeukemiaAcute LeukemiaClinical Trial Diversity

Outcome Measures

Primary Outcomes (1)

  • TEDD Utilization Rate

    Utilization will be measured as the proportion of quarters where a participant accessed the dashboard divided by the total number of study quarters. Based on 12 participants over 4 three-month quarters, there are a total of 48 person-quarters available for analysis.

    12 months

Study Arms (1)

TEDD Intervention

EXPERIMENTAL

12 medical professional participants will complete the following: * Baseline survey. * Usage and access of the TEDD intervention over a 12-month period. * Follow up surveys at the end of each quarter.

Behavioral: Trial Enrollment Diversity Dashboard Behavioral

Interventions

A data management and classification algorithm tool that provides personalized enrollment diversity performance data for clinician review and which aims to overcome race-ethnic disparities in Leukemia clinical trial participation. Data inputs and the Dashboard are within existing HIPAA-complaint electronic health records systems used at Dana-Farber Cancer Institute, and utilization data metrics are collected through the Tableau software supporting the intervention.

TEDD Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician, nurse practitioner, or physician assistant
  • ≥10% clinical effort (or one ½ day of clinic per week for those working \<1 FTE)
  • Treats adult patients with leukemia or related diseases at the study sites
  • Ability to understand and willingness to provide informed consent
  • Age 18 or older
  • Age ≥18 years old
  • Diagnosis of leukemia, lymphoma, myeloma, or related diseases
  • Seen by a physician for this diagnosis at one of the study sites

You may not qualify if:

  • Listed member of the research team
  • Participants without the diagnoses of interest listed above, participants not seen at the study sites.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Andrew Hantel, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 27, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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: \[contact information for Sponsor Investigator or designee\]. 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.

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

Locations