Develop and Evaluate An Artificial Intelligence Assisted Prehabilitation Program for Returning to Work and Cost-effectiveness Analysis in Patients With Oral Cancer

Обзор

The goal of this clinical trial is to develop and evaluate an Artificial Intelligence Assisted Prehabilitation Program (AI APP) for returning to work and cost-effectiveness analysis in patients with oral cancer (OC). The main questions it aims to answer are: * What kinds of needs are related to returning to work (RTW) in patients with OC from diagnosis to survival that we can incorporate into the development of AI APP to assist this population ? * How is the effect of the AI APP that based on findings from the first question for patients with OC on physical and psychological distress, fear of recurrence, self-efficacy in coping with cancer, communication, motor function, quality of life, and RTW? * How is the effect of the RTW AI prediction model to identify high-risk groups ? And how is the comprehensive cost effectiveness of benefits and quality of life of the AI APP for OC population? Researchers will compare patients without using AI APP to see if the AI APP works to assist with coping physical and psychological distress, communication, motor function, quality of life, and RTW issues for individuals with OC? Participants will: * Be asked to fulfill a structural questionnaire, or engage in a semi-structured one-by-one interview or a focus group to assess their physical, psychological, and social support needs in the first stage. * Be invited to participant the pilot testing of AI APP in the second stage. * Be provided and trained by 3-month AI APP for 3 months or cared as usual in the third stage. * Complete a structural questionnaire and follow up one year, including the baseline (before using the AI app) and at 1-2 weeks, 3 months, 6 months, 9 months, and 12 months after the baseline. * Engage in one-by-one interview or a focus group to assess user experiences of the AI APP.

Вмешательства

• Устройство Prehabilitation application
  Participants will use an Artificial Intelligence Assisted Prehabilitation Program Application (AI Assisted Prehabilitation APP, AI APP), including Generative AI Assisted Psychosocial Support chat, AI-Based Postural Correction Programs Physiotherapy Prehabilitation, and Intelligent Learning-Based Communication Navigation Assistance System to assist individuals with OC dealing with their physical and psychological distress, motor function and communication issues, and social support throughout pre
• Поведенческое Conventional physiotherapy
  jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks
• Поведенческое Scar management
  scar massage and jaw-mobilizing exercises combined with devices or depressors
• Поведенческое AI-based physiotherapy
  jaw, neck, shoulder ROM exercises, and scapular-focused exercises guided by AI technology, 30 minutes of intervention, once a week, and a total of 12 weeks

Первичные конечные точки

• Returning to work (RTW) [Срок оценки: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of distress on Distress Thermometer (DT) questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire [Срок оценки: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change from baseline in maximal mouth opening [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change from baseline in shoulder joint range of motion [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of self efficacy on the Cancer Behavior Inventory (CBI) questionnaire [Срок оценки: Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of health engagement on the Patient Health Engagement (PHE) questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of perceived voice handicap on the Voice Handicap Index-10 (VHI-10) questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change of the level of communication quality on the Communication Quality Assessment questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]

Вторичные конечные точки (5)

• Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change from baseline in health-related function on EORTC QLQ-C30 questionnaire [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change from baseline in whole-body physical function on 6-minute walk test [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• Change from baseline in shoulder pain [Срок оценки: Baseline (before surgery), 1-2 weeks after surgery, 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.]
• The user experience of the APP intervention [Срок оценки: 3 months after surgery, and 6 months after surgery]

Критерии участия

Критерии включения

• Adult (> 20 years old and younger than 70 years old)
• Newly diagnosed as OC and scheduled to receive cancer-related treatment
• Able to use Mobile phone
• Willing to sign an informed consent form after receiving a detailed explanation of the study's aims and procedures
• Healthcare professionals involved in patients' care, including doctors, nurses, case managers, dietitians, rehabilitation therapists, and psychologists
• Family members who are primary caregivers of the participating patients, engaged in different stages of medical care

Критерии исключения

• Risk populations for walking or performing exercise
• Patients with cognitive impairment or psychiatric diseases

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Тайвань · 5 центров

• National Taiwan University Hospital — Taipei
• National Yang Ming Chiao Tung University — Taipei
• National Yang Ming Chiao Tung University — Taipei
• National Yang Ming Chiao Tung University — Taipei
• Taipei Veterans General Hospital — Taipei

Идентификаторы

NCT: NCT07562100 · 2024-03-011BC · NSTC 113-2314-B-A49 -076 - · NSTC 114-2314-B-A49 -016 - · NSTC 113-2314-B-A49 -077 - · NSTC 114-2314-B-A49 -017 - · NSTC 113-2314-B-002 -298 - · NSTC 113-2314-B-A49 -078 - · NSTC 114-2314-B-002 -044 - · NSTC 114-2314-B-A49 -018 -

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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