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Recruiting NCT06907797

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

No phase Interventional Acute Leukemia Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRIAL Web-Based Application.
Who it may be relevant to
Registry conditions: Acute Leukemia, Leukemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Post-Test Completion Rate [Time frame: Day 14 or date of discharge]
  • System Usability Scale (SUS) Score [Time frame: Day 14 or date of discharge]
  • Percentage of Participants Scoring ≥68 on SUS [Time frame: approximately 12 months (based on total accrual duration)]
Secondary outcome measures (8)
  • Participant Screening Rate [Time frame: approximately 12 months (based on total accrual duration)]
  • Participant Eligibility Rate [Time frame: approximately 12 months (based on total accrual duration)]
  • Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test [Time frame: Baseline and day 14 or date of discharge (post-test)]
  • Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test [Time frame: Baseline and day 14 or day of discharge (post-test)]
  • Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test [Time frame: Baseline and day 14 or day of discharge (post-test)]
  • Ottawa Preparation for Decision Making Scale (Prep-DM) Score [Time frame: Day 14 or date of discharge]
  • Acceptability of Intervention Measure (AIM) Score [Time frame: Day 14 or date of discharge]
  • Participant Enrollment Agreement Rate [Time frame: approximately 12 months (based on total accrual duration)]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Dana-Farber Cancer Institute — Boston

Identifiers

NCT: NCT06907797 · 24-698 · K08CA273043

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗