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

NCT ID: NCT04049968

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-12-31

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.

Conditions

Oral Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Experimental group

Patients in the experimental group were individually assessed by a mobile health application (APP).

Group Type: EXPERIMENTAL

Mobile health application (APP)

Intervention Type: DEVICE

The mobile health application (APP) was applied to patients with oral cancer.

Control group

Patients in the control group were individually assessed by a traditional routine health care and instruction.

Group Type: ACTIVE_COMPARATOR

Routine health care and instruction

Intervention Type: OTHER

Traditional routine health care and instruction was applied to patients with oral cancer.

Interventions

Mobile health application (APP)

The mobile health application (APP) was applied to patients with oral cancer.

Intervention Type: DEVICE

Routine health care and instruction

Traditional routine health care and instruction was applied to patients with oral cancer.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 48 Years
• Maximum Eligible Age: 66 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Far Eastern Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lee-Chen Chen

Role: PRINCIPAL_INVESTIGATOR

Far Eastern Memorial Hospital

References

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.

Reference Type: DERIVED

PMID: 32716303 (View on PubMed)

Other Identifiers

105110-E

Identifier Type: -

Identifier Source: org_study_id