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

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Physiotherapy; Artifical Intelligence; Oral Cancer; Motor Function; Prehabilitation; Case Management, APP(Application); Cost Effectiveness; Psychological Distress; Prediction Model; Rehabilitation; Quality of Life; Return to Work; Communication Aids for Disabled; Physical Symptom Distress

Treatments: Behavioral: AI-based physiotherapy; Behavioral: Conventional physiotherapy; Behavioral: Scar management; Device: Prehabilitation application

Study type: Interventional

Funder types: Other

Identifiers

NCT07562100

NSTC 113-2314-B-002 -298 - (Other Grant/Funding Number)

NSTC 113-2314-B-A49 -078 - (Other Grant/Funding Number)

NSTC 114-2314-B-A49 -018 - (Other Grant/Funding Number)

NSTC 114-2314-B-A49 -017 - (Other Grant/Funding Number)

NSTC 113-2314-B-A49 -076 - (Other Grant/Funding Number)

NSTC 114-2314-B-002 -044 - (Other Grant/Funding Number)

2024-03-011BC

NSTC 113-2314-B-A49 -077 - (Other Grant/Funding Number)

NSTC 114-2314-B-A49 -016 - (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 650 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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650 participants in 2 patient groups

Control group Usual care

Active Comparator group

Description:

The patients in this group will not use the AI APP. They will receive 12 times of physiotherapy and keep receiving usual care.

Treatment:

Behavioral: Scar management

Behavioral: Conventional physiotherapy

Intervention group

Experimental group

Description:

The patients in this group will receive and use AI APP while receiving usual care.

Treatment:

Device: Prehabilitation application

Behavioral: Scar management

Behavioral: AI-based physiotherapy