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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
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

48 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 4, 2019
    Last Updated
    August 7, 2019
    Sponsor
    Far Eastern Memorial Hospital
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    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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