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

Not Applicable

Recruiting

• Conditions: Acute Leukemia; Leukemia

• Registration Number: NCT06907797
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study First Submitted: 2025-03-26
• Study First Submitted QC: 2025-03-26
• Study Start: 2025-04-01
• Study First Posted: 2025-04-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-07-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Post-Test Completion Rate	Day 14 or date of discharge	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.
System Usability Scale (SUS) Score	Day 14 or date of discharge	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.
Percentage of Participants Scoring ≥68 on SUS	approximately 12 months (based on total accrual duration)	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.

Secondary Outcome Measures

Name	Time	Method
Participant Screening Rate	approximately 12 months (based on total accrual duration)	Defined as the proportion of enrollees over the number of participants approached for study enrollment.
Participant Eligibility Rate	approximately 12 months (based on total accrual duration)	Defined as the proportion of enrollees over the number of participants eligible for study enrollment.
Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test	Baseline and day 14 or date of discharge (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.
Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test	Baseline and day 14 or day of discharge (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
Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test	Baseline and day 14 or day of discharge (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.
Ottawa Preparation for Decision Making Scale (Prep-DM) Score	Day 14 or date of discharge	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.
Acceptability of Intervention Measure (AIM) Score	Day 14 or date of discharge	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.
Participant Enrollment Agreement Rate	approximately 12 months (based on total accrual duration)	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.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States