Oral CancerAASPNCT07301047
App-Assisted Swallowing Program After Oral Cancer Surgery
A study testing Swallowing Care + Exercise App and Routine Postoperative Care in people with Oral Cancer and Reconstructive Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study aims to examine the effects of a swallowing care program combined with an exercise mobile application (App) on swallowing function, anxiety, and quality of life in patients with oral cancer after flap reconstruction surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Reconstructive Surgery, Postoperative
- What is being tested?
- Swallowing Care + Exercise App and Routine Postoperative Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign a written informed consent form
- Diagnosed with oral cancer
- Hospitalized for first-time oral cancer tumor resection and flap reconstruction surgery
- Aged 18 years or older
- Conscious and mentally clear
- Able to communicate in Mandarin or Taiwanese
Who cannot join
- Diagnosed by a physician with poor postoperative wound healing that prevents participation in oral rehabilitation exercises
- Unable to perform oral rehabilitation exercises within one week after surgery, as determined by a physician
- Withdrawal Criteria:
- -Participants who withdraw consent at any time during the study will be excluded from further participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taoyuan City, 333
About this study
This study aims to examine the effects of a swallowing care program combined with an exercise mobile application (App) on swallowing function, anxiety, and quality of life in patients with oral cancer after flap reconstruction surgery. The goal is to determine whether integrating App-based swallowing exercises into postoperative care can improve rehabilitation outcomes compared with conventional care alone.
A purposive sampling method will be used to recruit 72 participants from the surgical wards of a medical center in northern Taiwan. Eligible patients scheduled for oral cancer tumor resection and flap reconstruction will be identified through consultation with plastic surgeons. After screening and informed consent, participants will be assigned to a control group or an experimental group, with approximately 36 patients in each group.
Read more
The control group will receive routine ward education and standard postoperative nursing care, while the experimental group will receive the same care plus an additional intervention using a swallowing exercise App. The intervention will begin on postoperative day 7, guided by the researcher. Follow-up assessments will be conducted during outpatient visits at postoperative week 4 and week 12. To minimize potential interference between participants, data collection will be performed sequentially-first for the control group, followed by the experimental group.
Data will be collected through self-administered questionnaires or researcher-assisted interviews, including a demographic survey, the Postoperative Oral Dysfunction-10 (POD-10), the Functional Oral Intake Scale (FOIS), a Visual Analog Scale for Anxiety, and the EORTC QLQ-H\&N35 questionnaire for quality of life. Each assessment will take approximately 20-30 minutes. Participants may withdraw from the study at any time without penalty.
Descriptive statistics will be used to summarize participant characteristics. The chi-square test and independent t-test will be used to examine group homogeneity. Paired t-tests will be applied to evaluate within-group changes in swallowing function, anxiety, and quality of life before and after the intervention. The results of this study are expected to provide empirical evidence on the effectiveness of App-assisted swallowing rehabilitation for patients with oral cancer following reconstructive surgery, supporting the development of innovative, technology-based postoperative care models.
Read the detailed description
This study adopts a purposive sampling method and will be conducted in surgical wards of a medical center in northern Taiwan. A total of 72 participants will be recruited, with approximately 36 patients in the experimental group and 36 in the control group, based on the sample size estimation.
Participants will be identified by the researcher through consultation with plastic surgeons regarding patients scheduled for oral cancer tumor resection and flap reconstruction surgery. Eligible patients will be screened according to inclusion and exclusion criteria. One day before surgery, the researcher will explain the study purpose and procedures to each patient. Those who agree to participate will sign an informed consent form and complete the baseline questionnaires either by self-administration or interview.
After surgery, when patients return to the ward, the intervention will begin on postoperative day 7. Participants will be divided into two groups:
Control group: receives routine ward education and standard postoperative care. Experimental group: receives the same routine care plus an additional intervention using a swallowing exercise mobile application (App). The researcher will assist participants in downloading and using the App.
Follow-up assessments will be conducted at 4 weeks and 12 weeks after surgery during outpatient clinic visits. To prevent contamination between participants, data will be collected sequentially-first from the control group and then from the experimental group.
Data collection instruments include a demographic questionnaire, the Postoperative Oral Dysfunction-10 (POD-10), Functional Oral Intake Scale (FOIS), Visual Analog Scale for Anxiety, and EORTC QLQ-H\&N35 for quality of life. Each interview or questionnaire session will take approximately 20-30 minutes. Participants may withdraw at any time during the data collection process without penalty.
Data analysis will be performed using descriptive statistics to summarize participant characteristics. Homogeneity between groups will be tested using chi-square and independent t-tests. Paired t-tests will be used to compare pre- and post-intervention differences within groups. The study aims to evaluate the effects of an App-based swallowing exercise intervention on swallowing function, anxiety, and quality of life among patients with oral cancer after flap reconstruction surgery.
- Conditions
- Oral Cancer, Reconstructive Surgery, Postoperative
- Being tested
- Swallowing Care + Exercise App, Routine Postoperative Care
- Keywords
- Oral Cancer, Postoperative, Reconstructive Surgery
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing Care + Exercise AppBehavioural
Participants receive a swallowing care program combined with a mobile exercise App, starting on postoperative day 7. The App provides guided swallowing exercises, reminders, and progress tracking. Follow-up assessments at weeks 4 and 12.
Routine Postoperative CareBehavioural
Participants receive standard postoperative care and routine ward education without the App-based swallowing intervention. Assessments at the same time points as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing Care + Exercise App Intervention | Experimental | Participants receive a swallowing care program combined with a mobile exercise App, starting on postoperative day 7. The App provides guided swallowing exercises, reminders, and progress tracking. Follow-up assessments at weeks 4 and 12. Receives: Behavioral: Swallowing Care + Exercise App |
| Routine Postoperative Care | Active comparator | Participants receive standard postoperative care and routine ward education without the App-based swallowing intervention. Assessments at the same time points as the experimental group. Receives: Behavioral: Routine Postoperative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Oral Dysfunction-10 (POD-10) questionnaire
Swallowing-related oral dysfunction was assessed using the Postoperative Oral Dysfunction-10 (POD-10) questionnaire. The POD-10 is a patient-reported outcome measure consisting of 10 items, with total scores ranging from 0 to 40, where higher scores indicate more severe oral dysfunction.
Measured: Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.
The Functional Oral Intake Scale (FOIS)
Functional swallowing ability was evaluated using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from Level 1 (nothing by mouth) to Level 7 (total oral diet with no restrictions), where higher scores represent better oral intake function.
Measured: Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.
Secondary outcomes (1)
anxiety
Anxiety levels were assessed using the Visual Analog Scale for Anxiety (VAS-A). The scale ranges from 0 to 10, where 0 indicates no anxiety and 10 indicates the highest level of anxiety, with higher scores reflecting greater anxiety severity.
Measured: begin on postoperative day 7, during outpatient visits at postoperative week 4 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study adopts a quasi-experimental design using a non-randomized, two-group, pretest-posttest model. Participants are assigned sequentially to either the control or experimental group to avoid potential contamination between participants. The control group receives routine postoperative care, while the experimental group receives the same care plus an additional intervention using a swallowing exercise mobile application (App). Outcomes, including swallowing function, anxiety, and quality of life, are measured at baseline (pre-intervention), 4 weeks, and 12 weeks after surgery.
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenchuan Hsu, MS, Chang Gung Memorial Hospital
- Investigators
- Yean Hsiao Chiu, PHD, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301047
- Sponsor's protocol ID
- 202501330B0
- Acronym
- AASP
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable. Individual participant data will not be shared. Only aggregated study results may be published in scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- App-Assisted Swallowing Program After Oral Cancer Surgery
- ClinicalTrials.gov ID
- NCT07301047
- Acronym / sponsor ID
- AASP / 202501330B0
- Conditions
- Oral Cancer, Reconstructive Surgery, Postoperative
- Keywords
- Oral Cancer, Postoperative, Reconstructive Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Dec 2025 (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 aims to examine the effects of a swallowing care program combined with an exercise mobile application (App) on swallowing function, anxiety, and quality of life in patients with oral cancer after flap reconstruction surgery. The goal is to determine whether integrating App-based swallowing exercises into postoperative care can improve rehabilitation outcomes compared with conventional care alone.
A purposive sampling method will be used to recruit 72 participants from the surgical wards of a medical center in northern Taiwan. Eligible patients scheduled for oral cancer tumor resection and flap reconstruction will be identified through consultation with plastic surgeons. After screening and informed consent, participants will be assigned to a control group or an experimental group, with approximately 36 patients in each group.
The control group will receive routine ward education and standard postoperative nursing care, while the experimental group will receive the same care plus an additional intervention using a swallowing exercise App. The intervention will begin on postoperative day 7, guided by the researcher. Follow-up assessments will be conducted during outpatient visits at postoperative week 4 and week 12. To minimize potential interference between participants, data collection will be performed sequentially-first for the control group, followed by the experimental group.
Data will be collected through self-administered questionnaires or researcher-assisted interviews, including a demographic survey, the Postoperative Oral Dysfunction-10 (POD-10), the Functional Oral Intake Scale (FOIS), a Visual Analog Scale for Anxiety, and the EORTC QLQ-H\&N35 questionnaire for quality of life. Each assessment will take approximately 20-30 minutes. Participants may withdraw from the study at any time without penalty.
Descriptive statistics will be used to summarize participant characteristics. The chi-square test and independent t-test will be used to examine group homogeneity. Paired t-tests will be applied to evaluate within-group changes in swallowing function, anxiety, and quality of life before and after the intervention. The results of this study are expected to provide empirical evidence on the effectiveness of App-assisted swallowing rehabilitation for patients with oral cancer following reconstructive surgery, supporting the development of innovative, technology-based postoperative care models.
Detailed description
This study adopts a purposive sampling method and will be conducted in surgical wards of a medical center in northern Taiwan. A total of 72 participants will be recruited, with approximately 36 patients in the experimental group and 36 in the control group, based on the sample size estimation.
Participants will be identified by the researcher through consultation with plastic surgeons regarding patients scheduled for oral cancer tumor resection and flap reconstruction surgery. Eligible patients will be screened according to inclusion and exclusion criteria. One day before surgery, the researcher will explain the study purpose and procedures to each patient. Those who agree to participate will sign an informed consent form and complete the baseline questionnaires either by self-administration or interview.
After surgery, when patients return to the ward, the intervention will begin on postoperative day 7. Participants will be divided into two groups:
Control group: receives routine ward education and standard postoperative care. Experimental group: receives the same routine care plus an additional intervention using a swallowing exercise mobile application (App). The researcher will assist participants in downloading and using the App.
Follow-up assessments will be conducted at 4 weeks and 12 weeks after surgery during outpatient clinic visits. To prevent contamination between participants, data will be collected sequentially-first from the control group and then from the experimental group.
Data collection instruments include a demographic questionnaire, the Postoperative Oral Dysfunction-10 (POD-10), Functional Oral Intake Scale (FOIS), Visual Analog Scale for Anxiety, and EORTC QLQ-H\&N35 for quality of life. Each interview or questionnaire session will take approximately 20-30 minutes. Participants may withdraw at any time during the data collection process without penalty.
Data analysis will be performed using descriptive statistics to summarize participant characteristics. Homogeneity between groups will be tested using chi-square and independent t-tests. Paired t-tests will be used to compare pre- and post-intervention differences within groups. The study aims to evaluate the effects of an App-based swallowing exercise intervention on swallowing function, anxiety, and quality of life among patients with oral cancer after flap reconstruction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study adopts a quasi-experimental design using a non-randomized, two-group, pretest-posttest model. Participants are assigned sequentially to either the control or experimental group to avoid potential contamination between participants. The control group receives routine postoperative care, while the experimental group receives the same care plus an additional intervention using a swallowing exercise mobile application (App). Outcomes, including swallowing function, anxiety, and quality of life, are measured at baseline (pre-intervention), 4 weeks, and 12 weeks after surgery.
| Arm | Type | Receives |
|---|---|---|
| Swallowing Care + Exercise App Intervention | Experimental | Behavioral: Swallowing Care + Exercise AppParticipants receive a swallowing care program combined with a mobile exercise App, starting on postoperative day 7. The App provides guided swallowing exercises, reminders, and progress tracking. Follow-up assessments at weeks 4 and 12. |
| Routine Postoperative Care | Active comparator | Behavioral: Routine Postoperative CareParticipants receive standard postoperative care and routine ward education without the App-based swallowing intervention. Assessments at the same time points as the experimental group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing to sign a written informed consent form
- Diagnosed with oral cancer
- Hospitalized for first-time oral cancer tumor resection and flap reconstruction surgery
- Aged 18 years or older
- Conscious and mentally clear
Key exclusion criteria (4 listed)
- Diagnosed by a physician with poor postoperative wound healing that prevents participation in oral rehabilitation exercises
- Unable to perform oral rehabilitation exercises within one week after surgery, as determined by a physician
- -Participants who withdraw consent at any time during the study will be excluded from further participation
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 |
|---|---|---|
| Swallowing Care + Exercise AppParticipants receive a swallowing care program combined with a mobile exercise App, starting on postoperative day 7. The App provides guided swallowing exercises, reminders, and progress tracking. Follow-up assessments at weeks 4 and 12. | Behavioural | Swallowing Care + Exercise App Intervention |
| Routine Postoperative CareParticipants receive standard postoperative care and routine ward education without the App-based swallowing intervention. Assessments at the same time points as the experimental group. | Behavioural | Routine Postoperative Care |
Primary outcome
Postoperative Oral Dysfunction-10 (POD-10) questionnaire
Time frame: Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.
Swallowing-related oral dysfunction was assessed using the Postoperative Oral Dysfunction-10 (POD-10) questionnaire. The POD-10 is a patient-reported outcome measure consisting of 10 items, with total scores ranging from 0 to 40, where higher scores indicate more severe oral dysfunction.
The Functional Oral Intake Scale (FOIS)
Time frame: Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.
Functional swallowing ability was evaluated using the Functional Oral Intake Scale (FOIS), a 7-point ordinal scale ranging from Level 1 (nothing by mouth) to Level 7 (total oral diet with no restrictions), where higher scores represent better oral intake function.
1 secondary outcome
anxiety
Time frame: begin on postoperative day 7, during outpatient visits at postoperative week 4 and week 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Chang Gung Memorial Hospital Official WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not applicable. Individual participant data will not be shared. Only aggregated study results may be published in scientific journals.
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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.
Yean Hsiao Chiu, PHD study director
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing Care + Exercise App and Routine Postoperative Care in people with Oral Cancer and Reconstructive Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 6 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CHUAN WEN HSU, Master (886+0975367585 ext. 886+033281200*, f22877@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Oral Dysfunction-10 (POD-10) questionnaire (time frame: Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.). 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?
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 24 Dec 2025.