Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
Primary Purpose
Oral Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mobile health application (APP)
Routine health care and instruction
Sponsored by
About this trial
This is an interventional health services research trial for Oral Cancer focused on measuring Oral cancer、Post-Operation Needs、Quality of Life、APP
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients in the experimental group were individually assessed by a mobile health application (APP).
Patients in the control group were individually assessed by a traditional routine health care and instruction.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04049968
First Posted
August 4, 2019
Last Updated
August 7, 2019
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04049968
Brief Title
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
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer
Keywords
Oral cancer、Post-Operation Needs、Quality of Life、APP
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients in the experimental group were individually assessed by a mobile health application (APP).
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients in the control group were individually assessed by a traditional routine health care and instruction.
Intervention Type
Device
Intervention Name(s)
Mobile health application (APP)
Intervention Description
The mobile health application (APP) was applied to patients with oral cancer.
Intervention Type
Other
Intervention Name(s)
Routine health care and instruction
Intervention Description
Traditional routine health care and instruction was applied to patients with oral cancer.
Primary Outcome Measure Information:
Title
Changes of the subjects' quality of life
Description
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.
Time Frame
3 month
Title
Changes of the subjects' physiological needs
Description
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.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Changes of the subjects' response to health IT
Description
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.
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee-Chen Chen
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data is currently under analysis.
Citations:
PubMed Identifier
32716303
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.
Results Reference
derived
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Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
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