Listen Aphasia Pilot Study

Официальное название

LISTEN: Supporting Communication in Patients With Tumor-Related Aphasia

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1] [Срок оценки: Up to 12 months (Phase 1 refinement period).]
• Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 2] [Срок оценки: Up to 24 months (pre-pilot study period).]
• Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 2] [Срок оценки: Up to 24 months (pre-pilot study period).]
• Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 2] [Срок оценки: Up to 24 months (pre-pilot study period).]
• Acceptability of LISTEN Assessed by Acceptability of Intervention Measure (AIM) [Phase 3] [Срок оценки: At the end of the open pilot study (up to 48 months).]
• Appropriateness of LISTEN Assessed by Intervention Appropriateness Measure (IAM) [Phase 3] [Срок оценки: At the end of the open pilot study (up to 48 months).]
• Feasibility of LISTEN Assessed by Feasibility of Intervention Measure (FIM) [Phase 3] [Срок оценки: At the end of the open pilot study (up to 48 months).]

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

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
• 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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Brigham & Woman's Hospital — Boston
• Dana-Farber Cancer Center — Boston

Идентификаторы

NCT: NCT07732140 · 26-055 · CA250050

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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