Listen Aphasia Pilot Study

NCT07732140 | Not Yet Recruiting

• 2 other identifiers: 26-055CA250050
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. The study will assess the feasibility and acceptability of LISTEN in patients with TRA and their care partners.

Conditions

Aphasia; Malignant Brain Tumor

Keywords

Tumor-Related Aphasia (TRA); Malignant Brain Tumor

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (5)

• Sustained Use of LISTEN at 12 Weeks

  At 12 weeks following intervention initiation.

• Session Duration of LISTEN Use

  During participant use throughout the study period (up to 48 months).

• Task Completion Rate of LISTEN

  During participant use throughout the study period (up to 48 months).

• Error Rate During LISTEN Use

  During participant use throughout the study period (up to 48 months).

• Qualitative Usability Themes Identified From Think-Aloud Protocols and Exit Interviews

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

Study Arms (3)

Arm 1

OTHER

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)

Arm 2

OTHER

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)

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.

Device: LISTEN (AI-based AAC smartphone app)

Interventions

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.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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)

You may not qualify if:

• 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
• Unable to read or respond to questions in English

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Brigham & Woman's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Center

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Aphasia; Brain Neoplasms

Interventions

Auscultation

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John Rhee, MD, MPH

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Rhee, MD, MPH

CONTACT

(857) 215-3308; John_Rhee@DFCI.HARVARD.EDU

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

US (2)