Listen Aphasia Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute
About this trial
This is a feasibility and pilot study to refine and test LISTEN, an AI-based augmentative and alternative communication (AAC) smartphone app, integrated into the patient's personal electronic device, to augment and facilitate communication in patients with tumor-related aphasia (TRA) and their care partners. The study will assess the feasibility and acceptability of LISTEN in patients with TRA and their care partners.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
A histologically or cytologically confirmed primary or secondary brain tumor with expected ongoing deterioration in language as determined by their oncologist
Mild-to-moderate aphasia or other acquired communication disorder as determined by their oncologist or speech-language pathologist
ECOG Performance Status of ≤2 or Karnofsky Performance Status ≥60
Expected overall survival of >6 months
Disqualifiers
Unable to read or respond to questions in English
Severe dysarthria as determined by their oncologist
Aphasia that is moderate-to-sever enough that the patient cannot consent without a proxy
Expected survival of ≤ 6 months
Trial design
Design model
Single group
Treatments tested in this trial
LISTEN (AI-based AAC smartphone app)
DeviceLISTEN is a smartphone app leveraging AI and large language models (LLMs) to support personalized, adaptive communication for individuals with tumor-related aphasia. The app is customized with user-specific information and deployed through mobile applications with voice input/output capabilities.
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: Arm 1Other 1 intervention
Group B: Arm 2Other 1 intervention
Group C: Arm 3Other 1 intervention
Trial outcomes
Primary outcomes
1
Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1]
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.
Time frame
Up to 12 months (Phase 1 refinement period).2
Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 2]
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.
Time frame
Up to 24 months (pre-pilot study period).3
Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 2]
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.
Time frame
Up to 24 months (pre-pilot study period).4
Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 2]
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.
Time frame
Up to 24 months (pre-pilot study period).Secondary outcomes
1
Sustained Use of LISTEN at 12 Weeks
Sustained use of LISTEN will be assessed as the proportion of patients reporting ongoing use of augmentative and alternative communication (AAC) at 12 weeks following intervention initiation. Feasibility is defined as ≥50% of patients demonstrating sustained use.
Time frame
At 12 weeks following intervention initiation.2
Session Duration of LISTEN Use
Session duration will be assessed as the length of time participants interact with the LISTEN application during each use session
Time frame
During participant use throughout the study period (up to 48 months).3
Task Completion Rate of LISTEN
Task completion rate will be assessed as the proportion of tasks successfully completed by participants during interactions with the LISTEN application.
Time frame
During participant use throughout the study period (up to 48 months).4
Error Rate During LISTEN Use
Error rate will be assessed as the frequency of user errors encountered during interactions with the LISTEN application.
Time frame
During participant use throughout the study period (up to 48 months).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: