App-Assisted Swallowing Program After Oral Cancer Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Swallowing Care + Exercise App
BehavioralParticipants 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
BehavioralParticipants receive standard postoperative care and routine ward education without the App-based swallowing intervention. Assessments at the same time points as the experimental group.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Swallowing Care + Exercise App InterventionExperimental treatment 1 intervention
Group B: Routine Postoperative CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.2
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.
Time frame
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.
Time frame
begin on postoperative day 7, during outpatient visits at postoperative week 4 and week 12.Other outcomes
1
Change in Quality of Life Scores Measured by EORTC QLQ-H&N35 at 4 and 12 Weeks After Surgery
Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Head and Neck 35 (EORTC QLQ-H\&N35). The questionnaire comprises multiple head and neck cancer-specific symptom items, with scores linearly transformed to a 0-100 scale. Higher scores indicate greater symptom burden and poorer quality of life.
Time frame
postoperative day 7, during outpatient visits at postoperative week 4 and week 12.Sponsors and contacts
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Source ClinicalTrials.gov
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