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Completed

NCT Number: NCT04049968

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

48 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobile health application (APP)

Device

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

Routine health care and instruction

Other

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

Primary outcomes

  1. Changes of the subjects' quality of life

    Time frame: 3 month

    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.

  2. Changes of the subjects' physiological needs

    Time frame: 3 month

    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.

Secondary outcomes

  1. Changes of the subjects' response to health IT

    Time frame: 3 month

    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.

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2019
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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