Pilot Study of LISTEN App for Aphasia in Brain Tumor Patients
This study is testing a new smartphone app called LISTEN, which uses artificial intelligence (AI) to help people with aphasia (difficulty with language) caused by brain tumors communicate better. The app is designed to be personalized and adapt to your specific communication needs. We are looking for 80 participants who have a brain tumor and mild-to-moderate aphasia or another communication disorder. To be eligible, your doctor must expect your language abilities to continue to change. The main goals are to see how easy the LISTEN app is to use (usability), how well people like it (acceptability), and how appropriate it is for helping with communication. The study is currently recruiting participants.
- Study design
- This is a feasibility and pilot study with 80 participants, structured in three phases to refine and test the LISTEN app.
- What's involved
- You will participate in weekly to biweekly study visits for up to 16 weeks, and may be involved in interviews.
- Compensation
- Participants will be compensated for their time.
- Follow-up
- Participants will be followed for up to 16 weeks after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Listen Aphasia Pilot Study
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- John Rhee, MD, MPH · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1]Up to 12 months (Phase 1 refinement period).
Usability of the LISTEN prototype will be evaluated using the System Usability Scale (SUS) in patients with treatment-resistant anxiety (TRA) and their care partners. Participants will engage in think-aloud usability testing during daily communication scenarios, followed by completion of the SUS questionnaire after each session. The primary outcome is defined as a mean SUS score ≥70 across all participants, indicating acceptable usability.
- Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 2]Up to 24 months (pre-pilot study period).
Acceptability of the LISTEN application will be evaluated using the AIM developed by Weiner et al. (2017) to assess participants' perceived acceptability of the intervention in real-world settings; the outcome is defined as a mean AIM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable acceptability.
- Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 2]Up to 24 months (pre-pilot study period).
Appropriateness of the LISTEN application will be evaluated using the IAM developed by Weiner et al. (2017) to assess the perceived fit, relevance, and suitability of the intervention for the target population and context; the outcome is defined as a mean IAM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable appropriateness.
- Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 2]Up to 24 months (pre-pilot study period).
Feasibility of the LISTEN application will be evaluated using the FIM developed by Weiner et al. (2017) to assess the extent to which the intervention can be successfully used and implemented in real-world settings; the outcome is defined as a mean FIM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable feasibility.
- Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 3]At the end of the open pilot study (up to 48 months).
Acceptability of the LISTEN application will be evaluated of using AIM developed by Weiner et al. (2017) to assess participants' perceived acceptability of the intervention in real-world settings; participants will engage in a three-stage intervention (preparation, training, and testing at 4-week intervals), and the outcome is defined as a mean AIM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable acceptability.
- Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 3]At the end of the open pilot study (up to 48 months).
Appropriateness of the LISTEN application will be evaluated using IAM developed by Weiner et al. (2017) to assess the perceived fit, relevance, and suitability of the intervention for the target population and context; participants will engage in a three-stage intervention (preparation, training, and testing at 4-week intervals), and the outcome is defined as a mean IAM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable appropriateness.
- Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 3]At the end of the open pilot study (up to 48 months).
Feasibility of the LISTEN application will be evaluated using FIM developed by Weiner et al. (2017) to assess the extent to which the intervention can be successfully used and implemented in real-world settings; participants will engage in a three-stage intervention (preparation, training, and testing at 4-week intervals), and the outcome is defined as a mean FIM score ≥4 across all participants based on a 5-point Likert scale (1 = completely disagree to 5 = completely agree), indicating favorable feasibility.