An interventional study of LISTEN (AI-based AAC smartphone app) in Aphasia and Malignant Brain Tumor, sponsored by Dana-Farber Cancer Institute. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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.
The study will be conducted in three phases: (1) Refinement, (2) Pre-pilot, and (3) Open pilot feasibility study. In the Refinement phase, a functional prototype of LISTEN will be developed and iteratively refined with 10 patient-care-partner dyads (20 participants), stratified by tumor grade and illness stage. Usability will be assessed through think-aloud interviews, System Usability Scale (SUS), and qualitative exit interviews. The Pre-pilot phase will test LISTEN in real-world scenarios with 10 dyads, making final adjustments before the open pilot. The Open pilot will recruit 20 dyads (40 participants) to assess feasibility and acceptability using validated implementation measures (AIM, IAM, FIM). Participants will be followed for up to 16 weeks, with study visits occurring weekly to biweekly. Data will be collected and stored in REDCap, and participants will be compensated for their time. The study is minimal risk, with anticipated risks limited to emotional distress during interviews or technical difficulties with the app. The study is supported by Dana-Farber Cancer Institute and the Department of Defense.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 80 is above the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient inclusion criteria are as follows:
Care-partner inclusion criteria are as follows:
Exclusion Criteria:
Patient exclusion criteria are as follows:
Care-partner exclusion criteria are as follows:
-Unable to read or respond to questions in English
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refinement Phase - 10 patient-care-partner dyads (20 participants) will use the LISTEN prototype in a single session for usability testing.
Device: LISTEN (AI-based AAC smartphone app)
Pre-pilot Phase - 10 patient-care-partner dyads (20 participants) will use LISTEN in real-world scenarios for iterative refinement.
Device: LISTEN (AI-based AAC smartphone app)
Open Pilot Phase - 20 patient-care-partner dyads (40 participants) will use LISTEN for up to 16 weeks to assess feasibility and acceptability.
Device: LISTEN (AI-based AAC smartphone app)
LISTEN 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.
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).
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).
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).
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).
Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 3]
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.
Time frame: At the end of the open pilot study (up to 48 months).
Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 3]
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.
Time frame: At the end of the open pilot study (up to 48 months).
Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 3]
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.
Time frame: At the end of the open pilot study (up to 48 months).
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.
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).
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).
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).
Qualitative Usability Themes Identified From Think-Aloud Protocols and Exit Interviews
Qualitative data from think-aloud protocols and exit interviews will be transcribed and analyzed using rapid thematic content analysis to identify usability themes and inform iterative refinement of the LISTEN application.
Time frame: At the end of each session and throughout the study period (up to 48 months).
Plan to share: Yes — The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication.
Access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for May 2030, 40 months later.
Of 183 non-industry interventional studies with no phase under Aphasia, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 57. This study's planned 40 months is above that.
Counting every sponsor, half of 185 studies reached it within 36 months; a quarter within 20 and three quarters within 57.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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