Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing

This study aims to test the Tools for Reducing Inequity in Acute Leukemia (TRIAL) web-based application that is designed to support participants with acute leukemia by providing information and resources about leukemia and clinical trial participation.

Study Overview

• Status: Recruiting
• Conditions: Leukemia; Acute Leukemia
• Intervention / Treatment: Behavioral: TRIAL Web-Based Application

Detailed Description

The goal of this single-arm pilot study is to test the TRIAL web application which is designed to reduce inequity in clinical trial enrollment among participants with acute leukemia. The application aims to facilitate access to clinical trials and reduce barriers for underrepresented groups.

The research study procedures include screening for eligibility and questionnaires.

Participation in this research study is expected to last about 14 weeks.

It is expected about 75 people will participate in this study.

The National Cancer Institute (NCI) and American Society of Clinical Oncology (ASCO) are providing funding for this study.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew Hantel, MD; Phone Number: 617-582-9394; Email: Andrew_Hantel@dfci.harvard.edu
• Study Contact Backup: Name: Erin Gallagher; Phone Number: 857-215-2275; Email: erin_gallagher@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Andrew Hantel, MD; Phone Number: 617-582-9394; Email: Andrew_Hantel@dfci.harvard.edu
      • Principal Investigator: Andrew Hantel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or older
• English speaking
• Ability to understand and willingness to sign written informed consent
• Clinical suspicion of acute leukemia
• Admitted to DFCI-affiliated inpatient unit

Exclusion Criteria:

• Cognitive impairment rendering the individual unable to participate in beta testing

  • This will be assessed by focused chart review and consultation with the patients' inpatient care team.
• The following populations will be excluded: adults unable to consent, individuals who are not yet adults (infants, children, teenagers <18 years old), prisoners.
• Inability to participate in in-person application testing.
• Patients who participated in alpha-testing through protocol 23-404 (Appendix A)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRIAL Web-Based Application; Enrolled participants will complete: Baseline visit and questionnaires; Access to web application over the course of 14 days.; End of study questionnaires; 12 participants will take part in semi-structured interviews with study staff which will be audio recorded.	Behavioral: TRIAL Web-Based Application; A web-based application that provides disease and trial education and access to resources provided by the Leukemia and Lymphoma Society (LLS). iPads will be provided to participants for 14 days.; Other Names: TRIAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Test Completion Rate	Defined as the proportion of completed post-tests compared to the overall total of 75. Retention feasibility is defined as ≥ 70% of post-test completions, or 53 completions.	Day 14 or date of discharge
System Usability Scale (SUS) Score	Assessed by the System Usability Scale (SUS), a 10-item measure rated on a 5-point Likert scale from 1 "Strongly Disagree" to 5 "Strongly Agree" with a total scores range of 0 to 100. A higher score represents greater usability.	Day 14 or date of discharge
Percentage of Participants Scoring ≥68 on SUS	Defined as the proportion of participants who score ≥68 on the SUS compared to the overall enrollment of 75 participants. Usability of the intervention is defined as >70%, or 53 participants.	approximately 12 months (based on total accrual duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Screening Rate	Defined as the proportion of enrollees over the number of participants approached for study enrollment.	approximately 12 months (based on total accrual duration)
Participant Eligibility Rate	Defined as the proportion of enrollees over the number of participants eligible for study enrollment.	approximately 12 months (based on total accrual duration)
Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test	Assessed by the Seven-Item Knowledge Scale (SIKS) which is comprised of items covering general clinical research statements. Respondents indicate whether a statement is "True," "False," or "Don't know." Scoring is based on the number of correct items (range 0-100). "Don't know" and omitted responses do not count toward the score. A score of 70 or higher indicates adequate knowledge.	Baseline and day 14 or date of discharge (post-test)
Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test	Assessed by the Attitudes to Randomized Trials Questionnaire (ARTQ), a 7-item measure with answers of "Yes, "No," or "Do Not Know." The first three items represent willingness to participate in a clinical trial. These items will be assigned a value of 1 for an answer of "Yes" or 0 for an answer of "No or Do Not Know" and summed to obtain overall willingness. Change = (Day 14 or Discharge score - Baseline score)/Baseline score	Baseline and day 14 or day of discharge (post-test)
Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test	Assessed by the Trust in Medical Researchers scale (TMRS), a 12-item measure rated on a 5-point Likert scale with answers ranging from 1 "Strongly Disagree" to 5" Strongly Agree" with a total scores range of 12 to 48. A higher score indicates greater trust in medical researchers.	Baseline and day 14 or day of discharge (post-test)
Ottawa Preparation for Decision Making Scale (Prep-DM) Score	Assessed by the Ottawa Preparation for Decision Making Scale (Prep-DM), a 10-item measure rated on a 5-point Likert scale with answers ranging from 1 "Not at All" to 5 "A Great deal" with a total scores range of 0 to 100. A higher score indicates higher perceived level of preparedness for decision making.	Day 14 or date of discharge
Acceptability of Intervention Measure (AIM) Score	Assessed by the Acceptability of Intervention Measure (AIM), a 4-item measure rated on a 5-point Likert scale with answers ranging from 1 "Completely disagree" to 5 "Completely agree." A total scores range is 4 to 20 with a higher score indicating greater acceptability.	Day 14 or date of discharge
Participant Enrollment Agreement Rate	Defined as the proportion of participants that agree to participate in a clinical trial divided by the number of enrollment opportunities. For the purposes of this study, which does not impact clinician behaviors or trial eligibility criteria, a patient who agrees to enroll in a study is someone who is presented with information about a study and agrees to participate and either screen fails or passes screening and consents to participate. An enrollment opportunity is defined as a patient who is identified by the care team as screen eligible for a clinical trial and approached for participation.	approximately 12 months (based on total accrual duration)

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); American Society of Clinical Oncology
• Investigators: Principal Investigator: Andrew Hantel, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Leukemia; Acute Leukemia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia
• Other Study ID Numbers: 24-698; K08CA273043 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No