AphasiaLISTENNCT07732140

Listen Aphasia Pilot Study

A study testing LISTEN (AI-based AAC smartphone app) in people with Aphasia and Malignant Brain Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aphasia, Malignant Brain Tumor
What is being tested?: LISTEN (AI-based AAC smartphone app)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesUnited States
Study dates: Jan 2027to Dec 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient inclusion criteria are as follows:
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
Ability to understand and the willingness to sign a written consent form

Show all 14Show fewer

Age ≥18 years
Willingness to participate in study interviews and be recorded for the study (for monitoring of study fidelity)
Cancer survivors will also be included
Care-partner inclusion criteria are as follows:
Identified by their patient as someone who is integral to their care
Age ≥18 years
Ability to understand and the willingness to sign a written consent form
Willingness to participate in study interviews and be recorded for the study (monitoring of study fidelity)

Who cannot join

Patient exclusion criteria are as follows:
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
Severe cognitive impairment as determined by their oncologist
Care-partner exclusion criteria are as follows:
-Unable to read or respond to questions in English

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

John Rhee, MD, MPH contact

(857) 215-3308

John_Rhee@DFCI.HARVARD.EDU

United States2 sites

Brigham & Woman's Hospital
Boston, Massachusetts, 02115
John Rhee, MD. MPH, (857) 215-3308, John_Rhee@dfci.harvard.edu
John Rhee, MD, MPH, (857) 215-3308, John_Rhee@dfci.harvard.edu
Dana-Farber Cancer Center
Boston, Massachusetts, 02115
John Rhee, MD.MPH, (857) 215-3308, John_Rhee@dfci.harvard.edu
John Rhee, (857) 215-3308, John_Rhee@dfci.harvard.edu

Other trials in United States

About this study

Official title: LISTEN: Supporting Communication in Patients With Tumor-Related Aphasia

Read the detailed description

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.

Conditions: Aphasia, Malignant Brain Tumor
Being tested: LISTEN (AI-based AAC smartphone app)
Keywords: Tumor-Related Aphasia (TRA), Malignant Brain Tumor
Medical subject headings: Aphasia, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LISTEN (AI-based AAC smartphone app)Device
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.

Study groups in NCT07732140
Study group	Role	What they receive
Arm 1	Other	Refinement Phase - 10 patient-care-partner dyads (20 participants) will use the LISTEN prototype in a single session for usability testing. Receives: Device: LISTEN (AI-based AAC smartphone app)
Arm 2	Other	Pre-pilot Phase - 10 patient-care-partner dyads (20 participants) will use LISTEN in real-world scenarios for iterative refinement. Receives: Device: LISTEN (AI-based AAC smartphone app)
Arm 3	Other	Open Pilot Phase - 20 patient-care-partner dyads (40 participants) will use LISTEN for up to 16 weeks to assess feasibility and acceptability. Receives: Device: LISTEN (AI-based AAC smartphone app)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the open pilot study (up to 48 months).

Secondary outcomes (5)

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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of each session and throughout the study period (up to 48 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2027Dec 2030

First posted28 Jul 2026
Study startJan 2027 (estimated)
Primary completionMay 2030 (estimated)
Study completionDec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AphasiaStudies of the same condition, open and under way.
More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07732140
Sponsor's protocol ID: 26-055
Other IDs: CA250050
Acronym: LISTEN
Status last verified: Jul 2026
First submitted: 23 Jul 2026
Last updated: 28 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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.

Interested in taking part?

John Rhee, MD, MPH

(857) 215-3308

John_Rhee@DFCI.HARVARD.EDU

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
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Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
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All Aphasia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LISTEN: Supporting Communication in Patients With Tumor-Related Aphasia
ClinicalTrials.gov ID: NCT07732140
Acronym / sponsor ID: LISTEN / 26-055
Conditions: Aphasia, Malignant Brain Tumor
Keywords: Tumor-Related Aphasia (TRA), Malignant Brain Tumor
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Dana-Farber Cancer InstituteUniversity, hospital or other
Study start: Jan 2027 (estimated)
Primary completion: May 2030 (estimated)
Study completion: Dec 2030 (estimated)
First posted: 28 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm 1	Other	Device: LISTEN (AI-based AAC smartphone app)Refinement Phase - 10 patient-care-partner dyads (20 participants) will use the LISTEN prototype in a single session for usability testing.
Arm 2	Other	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.
Arm 3	Other	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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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
Ability to understand and the willingness to sign a written consent form

Key exclusion criteria (8 listed)

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
Severe cognitive impairment as determined by their oncologist

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Arm 1, Arm 2, Arm 3

Primary outcome

Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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]
Time frame: 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.

5 secondary outcomes

Sustained Use of LISTEN at 12 Weeks
Time frame: At 12 weeks following intervention initiation.
Session Duration of LISTEN Use
Time frame: During participant use throughout the study period (up to 48 months).
Task Completion Rate of LISTEN
Time frame: During participant use throughout the study period (up to 48 months).
Error Rate During LISTEN Use
Time frame: During participant use throughout the study period (up to 48 months).
Qualitative Usability Themes Identified From Think-Aloud Protocols and Exit Interviews
Time frame: At the end of each session and throughout the study period (up to 48 months).

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
Individual participant dataSharing planned: 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.

Related trials for Aphasia

Enrolling by invitation
Effects of Semantic Context on Criterion-learning Naming Treatment in Aphasia
Aphasia
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruiting
Personalized Closed-Loop Brain Stimulation for Patients With Primary Progressive Aphasia
PPA
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

John Rhee, MD, MPH contact

(857) 215-3308

John_Rhee@DFCI.HARVARD.EDU

John Rhee, MD, MPH principal investigator

Dana-Farber Cancer Institute

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LISTEN (AI-based AAC smartphone app) in people with Aphasia and Malignant Brain Tumor, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact John Rhee, MD, MPH ((857) 215-3308, John_Rhee@DFCI.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1] (time frame: Up to 12 months (Phase 1 refinement period).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.