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NCT Number: NCT07301047

App-Assisted Swallowing Program After Oral Cancer Surgery

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.

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Key information

Conditions

Oral Cancer Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Postoperative Reconstructive Surgery Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan, Taoyuan City, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Swallowing Care + Exercise App

Behavioral

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 Care

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. anxiety

    Time frame: begin on postoperative day 7, during outpatient visits at postoperative week 4 and week 12.

    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.

Other outcomes

  1. Change in Quality of Life Scores Measured by EORTC QLQ-H&N35 at 4 and 12 Weeks After Surgery

    Time frame: postoperative day 7, during outpatient visits at postoperative week 4 and week 12.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

CHUAN WEN HSU, Master

CONTACT

[email protected]

886+0975367585 ext. 886+033281200*

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Acronym: AASP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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