App-Assisted Swallowing Program After Oral Cancer Surgery

NCT07301047 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-12-24

No results posted yet for this study

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

Interventions

BEHAVIORAL

Swallowing Care + Exercise App

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

Routine Postoperative Care

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.

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yean Hsiao Chiu, PHD · Taipei Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07301047 on ClinicalTrials.gov