LISTEN: Supporting Communication in Patients With Tumor-Related Aphasia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1]
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Usability of LISTEN Assessed by the System Usability Scale (SUS) [Phase 1]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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]
时间窗: 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.
次要结局
- 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).)
研究者
John Y. Rhee
Principal Investigator
Dana-Farber Cancer Institute