Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing
2 other identifiers
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Typical duration for not_applicable
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
March 26, 2025
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 20, 2025
May 1, 2025
1.2 years
March 26, 2025
May 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (8)
Participant Screening Rate
approximately 12 months (based on total accrual duration)
Participant Eligibility Rate
approximately 12 months (based on total accrual duration)
Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test
Baseline and day 14 or date of discharge (post-test)
Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test
Baseline and day 14 or day of discharge (post-test)
Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test
Baseline and day 14 or day of discharge (post-test)
- +3 more secondary outcomes
Study Arms (1)
TRIAL Web-Based Application
EXPERIMENTALEnrolled 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- American Society of Clinical Oncologycollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Hantel, MD
Dana-Farber Cancer Institute
Central Study Contacts
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
- Principal Investigator
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 2, 2025
Study Start
April 1, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
June 30, 2027
Last Updated
May 20, 2025
Record last verified: 2025-05
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: \[contact information for Sponsor Investigator or designee\]. 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.