Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing
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.
Arms & interventions
- BehavioralTRIAL 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.
Outcome measures
Primary
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.
Time frame: 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.
Time frame: 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.
Time frame: approximately 12 months (based on total accrual duration)
Secondary
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
Study locations (1)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215