Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.

Study Overview
=================
Brief Summary
-----------------
This study aimed to explore using an APP in post oral cancer surgery to affect patients' needs and quality of life. Methods Quasi-experimental Research Design used purposeful sampling from January 1 to December 31 of the Far Eastern Memorial Hospital oral maxillofacial surgery ward and the otolaryngology ward requirement met post-treatment oral cancer patients who agreed to participate. Self-administered structured questionnaires, including basic personal information, cancer needs table short version (CNQ-SF), head and neck cancer quality of life scale (EORTC QLQ-H&N35), were used to collect information. Results were statistically analyzed to understand the distribution of variables and their relationships. Scientific or Clinical Implication of the Expected Results Using an APP intervention in post-operative patients with oral cancer may be the better way to promote health and enhance one's quality of life.

Detailed Description
-----------------
The malignant tumor has been consecutively ranked as number one of the top ten causes of death over the past 33 years, and the incidence of an increase in oral cancer year by year. The average age of death was 55-57. With this average age compared to other cancer patients under 10 years of early life, it's necessary to care about the burden of disease from oral cancer. The main treatment of oral cancer is surgery and a combination of radiotherapy and chemotherapy. Patients often got severe treatment complications with varying degrees of physical functions and uncertainty due to poor cognition or less clarification in a complex course of treatment that affects medical decisions in the illness process. Both domestic and foreign research show that the majority of oral cancer patients expressed the need for and attention to health information. Treatment information was the most needed and important. When information needs are met, it can effectively reduce the anxiety and unease of unknown events. Relevant domestic and foreign research do not provide accessibility and convenience of health education for post-operative patients with oral cancer.

Official Title
-----------------
Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.

Conditions
-----------------
Oral Cancer

Intervention / Treatment
-----------------
* Device: Mobile health application (APP)
* Other: Routine health care and instruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients were diagnosed with oral cancer and were the first-time receiving oral cancer surgery within 1 week. Conscious and able o communicate Patients agreed to participate in this study and had a smart phone. Exclusion Criteria: Patients without oral cancer Patients with oral cancer but had received oral cancer surgery before 1 week or more. Unconscious or unable to answer questions from questionnaire or APP Patients with cognitive impairment, dementia o intellectual disability.

Ages Eligible for Study
-----------------
Minimum Age: 48 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were divided into two two groups. Control group was assessed with traditional routine healthcare and instruction. Experimental group was assessed with a mobile health application.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patients in the experimental group were individually assessed by a mobile health application (APP). | Device: Mobile health application (APP)<br>* The mobile health application (APP) was applied to patients with oral cancer.<br>|
| Active Comparator: Control group<br>Patients in the control group were individually assessed by a traditional routine health care and instruction. | Other: Routine health care and instruction<br>* Traditional routine health care and instruction was applied to patients with oral cancer.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the subjects' quality of life | The Quality of Life scale (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core Module [EORTC QLQ-C30] and Head and Neck Module [QLQ-H&N35], or EORTC QLQ-H&N35) was used to represent patients' satisfaction with quality of life. The EORTC QLQ-H&N35 is a 30-item self-administered global health and quality of life questionnaire with 5 scales, including physical, role, cognitive, emotional and social functioning. In addition, the measuring items included the pain, swallowing, speech, taste/smell, eating, dry mouth, coughing, opening mouth and social contact and sexuality. | 3 month | 
| Changes of the subjects' physiological needs | Care Needs Scale (the short-form Cancer Needs Questionnaire, CNQ-SF) was used to measure baseline postoperative care needs, with score 0 meaning no care need and score 100 meaning highest care need. CNQ-SF is a 32-item self-administered questionnaire to evaluate five domains of patient needs, including psychological, health information, physical and daily living, patient care and support, and interpersonal communication needs. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the subjects' response to health IT | Science and Technology Acceptance Model scale was applied to evaluate patients' response to health IT. The scale measures subjects' intention, perceived usefulness, and perceived ease of use. Effectiveness is determined by a panel of experts, including nursing experts, nursing information experts and medical information experts. | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral cancer、Post-Operation Needs、Quality of Life、APP