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

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.

Study Overview

• Status: Completed
• Conditions: Oral Cancer
• Intervention / Treatment: Device: Mobile health application (APP); Other: Routine health care and instruction

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Investigators: Principal Investigator: Lee-Chen Chen, Far Eastern Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: August 4, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 8, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Oral cancer、Post-Operation Needs、Quality of Life、APP
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Neoplasms; Lip Neoplasms
• Other Study ID Numbers: 105110-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is currently under analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No