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) — 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.
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 1Refinement Phase - 10 patient-care-partner dyads (20 participants) will use the LISTEN prototype in a single session for usability testing.
- Other: Arm 2Pre-pilot Phase - 10 patient-care-partner dyads (20 participants) will use LISTEN in real-world scenarios for iterative refinement.
- Other: Arm 3Open 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
- John Rhee, MD, MPH(857) 215-3308
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brigham & Woman's Hospital | Boston | Massachusetts | 02115 | John Rhee, MD, MPH (PRINCIPAL_INVESTIGATOR) |
| Dana-Farber Cancer Center | Boston | Massachusetts | 02115 | John Rhee, MD, MPH (PRINCIPAL_INVESTIGATOR) |
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