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CompletedNCT04049968Updated Aug 8, 2019

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

An interventional study of Mobile health application (APP) and Routine health care and instruction in Oral Cancer, sponsored by Far Eastern Memorial Hospital. Completed. Open to participants aged 48 Years to 66 Years. Per ClinicalTrials.gov, last updated 2019-08-08.

Sponsored by Far Eastern Memorial Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jan 2017, registered Aug 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
48 Years to 66 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Oral Cancer

Keywords

  • Oral cancer、Post-Operation Needs、Quality of Life、APP
03

In context

Mouth Neoplasms

377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.

This study's enrollment of 100 is above the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Experimental group

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

    Device: Mobile health application (APP)

  • 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

Interventions

  • DeviceMobile health application (APP)

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

  • OtherRoutine health care and instruction

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 month

  2. 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.

    Time frame: 3 month

Secondary outcomes

  1. 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.

    Time frame: 3 month

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Study locations

No study locations are listed for this record.

08

References and documents

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. PubMed 32716303 ↗

Individual participant data

Plan to share: No — The data is currently under analysis.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04049968
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sponsor
First posted
Aug 8, 2019
Start date
Jan 1, 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Aug 8, 2019

Study contacts

Lee-Chen Chen
principal investigator · Far Eastern Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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