Clinical trial NCT04049968: Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
Official title: Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Cancer
Keywords: Oral cancer、Post-Operation Needs、Quality of Life、APP
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 48
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Changes of the subjects' quality of life
timeFrame: 3 month
measure: Changes of the subjects' physiological needs
timeFrame: 3 month
Secondary outcomes:
measure: Changes of the subjects' response to health IT
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Lee-Chen Chen
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang TF, Huang RC, Yang SC, Chou C, Chen LC. Evaluating the Effects of a Mobile Health App on Reducing Patient Care Needs and Improving Quality of Life After Oral Cancer Surgery: Quasiexperimental Study. JMIR Mhealth Uhealth. 2020 Jul 27;8(7):e18132. doi: 10.2196/18132.