Clinical trial NCT06907797: Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing
Official title: Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Leukemia
Leukemia
Keywords: Acute Leukemia
Leukemia
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: American Society of Clinical Oncology
name: National Cancer Institute (NCI)
First posted: 2025-04-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

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)

Primary outcomes:
measure: Post-Test Completion Rate
timeFrame: Day 14 or date of discharge
measure: System Usability Scale (SUS) Score
timeFrame: Day 14 or date of discharge
measure: Percentage of Participants Scoring ≥68 on SUS
timeFrame: approximately 12 months (based on total accrual duration)
Secondary outcomes:
measure: Participant Screening Rate
timeFrame: approximately 12 months (based on total accrual duration)
measure: Participant Eligibility Rate
timeFrame: approximately 12 months (based on total accrual duration)
measure: Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test
timeFrame: Baseline and day 14 or date of discharge (post-test)
measure: Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test
timeFrame: Baseline and day 14 or day of discharge (post-test)
measure: Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test
timeFrame: Baseline and day 14 or day of discharge (post-test)
measure: Ottawa Preparation for Decision Making Scale (Prep-DM) Score
timeFrame: Day 14 or date of discharge
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Day 14 or date of discharge
measure: Participant Enrollment Agreement Rate
timeFrame: approximately 12 months (based on total accrual duration)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Andrew Hantel, MD
role: PRINCIPAL_INVESTIGATOR
References: