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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Post-Test Completion Rate [Срок оценки: Day 14 or date of discharge]
• System Usability Scale (SUS) Score [Срок оценки: Day 14 or date of discharge]
• Percentage of Participants Scoring ≥68 on SUS [Срок оценки: approximately 12 months (based on total accrual duration)]

Вторичные конечные точки (8)

• Participant Screening Rate [Срок оценки: approximately 12 months (based on total accrual duration)]
• Participant Eligibility Rate [Срок оценки: approximately 12 months (based on total accrual duration)]
• Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to Post-Test [Срок оценки: Baseline and day 14 or date of discharge (post-test)]
• Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to Post-Test [Срок оценки: Baseline and day 14 or day of discharge (post-test)]
• Change in Trust in Medical Researchers Scale (TMRS) Score from Baseline to Post-Test [Срок оценки: Baseline and day 14 or day of discharge (post-test)]
• Ottawa Preparation for Decision Making Scale (Prep-DM) Score [Срок оценки: Day 14 or date of discharge]
• Acceptability of Intervention Measure (AIM) Score [Срок оценки: Day 14 or date of discharge]
• Participant Enrollment Agreement Rate [Срок оценки: approximately 12 months (based on total accrual duration)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06907797 · 24-698 · K08CA273043

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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