App-Assisted Swallowing Program After Oral Cancer Surgery

NCT07301047 | Not Yet Recruiting

• 1 other identifier: 202501330B0
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Cancer; Reconstructive Surgery; Postoperative

Keywords

Oral Cancer; Postoperative; Reconstructive Surgery

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Beginning on postoperative day 7, and during outpatient visits at postoperative week 4 and week 12.

Secondary Outcomes (1)

• anxiety

  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

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

Study Arms (2)

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.

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.

Behavioral: Routine Postoperative Care

Interventions

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.

Swallowing Care + Exercise App Intervention

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.

Routine Postoperative Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Linkou Branch

Taoyuan District, Taoyuan City, 333, Taiwan

Location

Related Links

• Chang Gung Memorial Hospital Official Website

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Yean Hsiao Chiu, PHD

  Taipei Medical University

  STUDY DIRECTOR

Central Study Contacts

CHUAN WEN HSU, Master

CONTACT

886+0975367585; f22877@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nursing supervisor

Model Details: 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.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)