Oral CancerNCT04049968
Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
A study testing Mobile health application (APP) and Routine health care and instruction in people with Oral Cancer, run by Far Eastern Memorial Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 48 to 66 years
- Conditions the study is for
- Oral Cancer
- What is being tested?
- Mobile health application (APP) and Routine health care and instruction
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Conditions
- Oral Cancer
- Being tested
- Mobile health application (APP), Routine health care and instruction
- Keywords
- Oral cancer、Post-Operation Needs、Quality of Life、APP
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile health application (APP)Device
The mobile health application (APP) was applied to patients with oral cancer.
Routine health care and instructionOther
Traditional routine health care and instruction was applied to patients with oral cancer.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients in the experimental group were individually assessed by a mobile health application (APP). Receives: Device: Mobile health application (APP) |
| Control group | Active comparator | Patients in the control group were individually assessed by a traditional routine health care and instruction. Receives: Other: Routine health care and instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 month
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.
Measured: 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.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee-Chen Chen, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049968
- Sponsor's protocol ID
- 105110-E
- Status last verified
- Nov 2016
- First submitted
- 4 Aug 2019
- Last updated
- 8 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is currently under analysis.
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an APP in Post Oral Cancer Surgery to Affect Patients' Needs and Quality of Life.
- ClinicalTrials.gov ID
- NCT04049968
- Acronym / sponsor ID
- 105110-E
- Conditions
- Oral Cancer
- Keywords
- Oral cancer、Post-Operation Needs、Quality of Life、APP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Mobile health application (APP)Patients in the experimental group were individually assessed by a mobile health application (APP). |
| Control group | Active comparator | Other: Routine health care and instructionPatients in the control group were individually assessed by a traditional routine health care and instruction. |
Who may qualify
- Ages
- 48 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile health application (APP)The mobile health application (APP) was applied to patients with oral cancer. | Device | Experimental group |
| Routine health care and instructionTraditional routine health care and instruction was applied to patients with oral cancer. | Other | Control group |
Primary outcome
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.
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.
1 secondary outcome
Changes of the subjects' response to health IT
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Derived from this study: PubMed 32716303Wang 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.
- Individual participant dataSharing planned: No. The data is currently under analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee-Chen Chen principal investigator
Far Eastern Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Mobile health application (APP) and Routine health care and instruction in people with Oral Cancer, run by Far Eastern Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the subjects' quality of life (time frame: 3 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049968, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2019.