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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Risk populations for walking or performing exercise

Patients with cognitive impairment or psychiatric diseases

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prehabilitation application

    Device

    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 prehabilitaion and rehabilitation to help them better returning to work.

  • Conventional physiotherapy

    Behavioral

    jaw, neck, shoulder ROM exercises, and scapular-focused exercises, 30 minutes of intervention, once a week, and a total of 12 weeks

  • Scar management

    Behavioral

    scar massage and jaw-mobilizing exercises combined with devices or depressors

  • AI-based physiotherapy

    Behavioral

    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

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Control group Usual careActive comparator 2 interventions
Group B: Intervention groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Returning to work (RTW)

A self-designed structured Employment status with one item collecting patients working status of "not employed", "part-time", or "full-time".

Time frame
Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.
2

Change of the level of symptom severity on Symptom Severity Scale (SSS) questionnaire

The Symptom Severity Scale (SSS): This scale is used to assess the severity of symptoms in cancer patients, demonstrating good validity through testing in HNC patients \[30\]. It includes 13 items of common symptoms among cancer patients, including swallowing difficulty, eating difficulty, oral mucositis, speech difficulty, fatigue, poor appetite, pain, cough, apnea, constipation, diarrhea, nausea, and vomiting. Scores range from 0 to 10, where 0 indicates the absence of the symptom, and 10 represents the most severe symptoms. Higher scores indicate a higher severity of symptoms.

Time frame
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.
3

Change of the level of distress on Distress Thermometer (DT) questionnaire

Distress Thermometer (DT): It is a screening tool developed by The National Comprehensive Cancer Network® (NCCN®) to identify the clinical severity of psychological distress and specific problems causing distress among cancer patients. The DT is a self-report one-item measure assessing the level of distress that patients have experienced in the previous week; the scale ranges from 0 (no distress) to 10 (extreme distress). The DT consists of 36 problems answered with "no" or "yes," and it is clustered into five domains: practical problems, family problems, emotional problems, spiritual problems, and physical problems. This scale has been validated and used in Chinese cancer patients and has shown good reliability. It has also been validated with a good sensitivity (72.2%), specificity (80.0%), and accuracy (79.2%) in Taiwanese cancer patients.

Time frame
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.
4

Change of the level of fear of recurrence on the Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF) questionnaire

Fear of Cancer Recurrence Inventory-Short Form (FCRI-SF): The FCRI-SF with nine items is a self-report measure designed to evaluate the presence and severity of intrusive thoughts associated with fear of cancer recurrence (FCR). Each item is rated on a 0 (not at all) to 4 (all the time) numerical rating scale. The total score is the sum of the items, ranging from 0 to 36. Higher scores indicate a higher level of FCR. A threshold of 13 or greater was categorized for patients with FCR. The FCRI-SF is a valid and reliable instrument in oncology patients in both English and Chinese.

Time frame
Baseline (before surgery), 3 months after surgery, 6 months after surgery, 9 months after surgery, and 12 months after surgery.

Secondary outcomes

1

Change from baseline in function on Disabilities of the Arm, Shoulder, and Hand outcome questionnaire

A total scale from 1 to 100. Higher scores indicate greater disability.

Time frame
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.
2

Change from baseline in health-related function on EORTC QLQ-C30 questionnaire

European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30): The questionnaire includes five functional subscales: physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning. In addition, it assesses a range of cancer-related symptoms, including fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties. Most of the items are scored on a 4-point Likert-type scale, ranging from 1 ("not at all") to 4 ("very much"), with higher scores indicating greater symptom burden or lower functioning. Two items assess global health status/overall quality of life, scored on a 7-point Likert-type scale ranging from 1 ("very poor") to 7 ("excellent"), where higher scores reflect better quality of life.

Time frame
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.
3

Change from baseline in whole-body physical function on 6-minute walk test

Walking distance measured in meters.

Time frame
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.
4

Change from baseline in shoulder pain

Visual analog scale from 0 to 10. Higher scores indicate most pain.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

National Taiwan University Hospital

Collaborator

National Yang Ming Chiao Tung University Hospital

Collaborator