Tools for Reducing Inequity in Acute Leukemia (TRIAL): Beta Testing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
English speaking
Ability to understand and willingness to sign written informed consent
Clinical suspicion of acute leukemia
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
TRIAL Web-Based Application
BehavioralA 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: TRIAL Web-Based ApplicationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 discharge2
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 discharge3
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 outcomes
1
Participant Screening Rate
Defined as the proportion of enrollees over the number of participants approached for study enrollment.
Time frame
approximately 12 months (based on total accrual duration)2
Participant Eligibility Rate
Defined as the proportion of enrollees over the number of participants eligible for study enrollment.
Time frame
approximately 12 months (based on total accrual duration)3
Change in Seven-Item Knowledge Scale (SIKS) Score from Baseline to 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.
Time frame
Baseline and day 14 or date of discharge (post-test)4
Change in Attitudes to Randomized Trials Questionnaire (ARTQ) Score from Baseline to 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
Time frame
Baseline and day 14 or day of discharge (post-test)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Dana-Farber Cancer Institute
Lead sponsor
American Society of Clinical Oncology
Collaborator
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov