Listen Aphasia Pilot Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT07732140
Status
Not Yet Recruiting

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Conditions

  • Aphasia
  • Malignant Brain Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Jan 31, 2027
Status verified
Jul 2026
Primary completion
May 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Arm 1
    Refinement Phase - 10 patient-care-partner dyads (20 participants) will use the LISTEN prototype in a single session for usability testing.
  • Other: Arm 2
    Pre-pilot Phase - 10 patient-care-partner dyads (20 participants) will use LISTEN in real-world scenarios for iterative refinement.
  • Other: Arm 3
    Open Pilot Phase - 20 patient-care-partner dyads (40 participants) will use LISTEN for up to 16 weeks to assess feasibility and acceptability.

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). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham & Woman's HospitalBostonMassachusetts02115
John Rhee, MD. MPH
(857) 215-3308
John Rhee, MD, MPH
(857) 215-3308
John Rhee, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer CenterBostonMassachusetts02115
John Rhee, MD.MPH
(857) 215-3308
John Rhee
(857) 215-3308
John Rhee, MD, MPH (PRINCIPAL_INVESTIGATOR)

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