Clinical trial · Observational
Eating Difficulties in HNC Patients - Influencing Factors and Short and Long Term Impacts on PF and Depression
Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Background: Eating difficulty is one of the most common problems faced by head and neck cancer (HNC) patients and it might influence patients' general function and psychological function. Unfortunately, the eating difficulties in HNC patients are not fully understood due to limited research presented. Purposes: The study is a 2-year longitudinal following up research. The purpose of the study aim to (1) examine the characteristics and severity of eating difficulty, (2) identify factors related to the eating difficulty, and (3) short and long-term impact and correlation of eating difficulty on HNC patients' general physical condition and depression. Method: Eligible patient will be HNC patients receiving surgery and CCRT. Patients will be recruited and assessed in 6 time points: before first CCRT (T1) and 4weeks, 8 week, 12 week , 6 month, and 12 month from CCRT (T2\~T6). Patients will be assessed nutrition status, body weight, fatigue severity, and grip power of the dominant hand, and depression. IRB and patient consents will be obtained before data collection. The descriptive and correlational analyses will be applied to analyze the data. The investigators plan to recruit 125 subjects. The longitudinal data will be analyzed by GEE to examine the changes of main variables and predictors of eating difficulty. Expected Outcome: The results of this study will provide evidence about HNC patients' eating difficulty. It will increase health care professionals' understanding about HNC patients' problems in eating difficulties, related factors and their relationship with general function. The investigators hope to further develop an intervention based on the results to enhance HNC patients' eating function.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Head and neck cancer
- description
- Eating difficulty is one of the most common problems for head and neck cancer (HNC), in particular, who are in advanced disease stage and receive surgery, radiation (RT) or concurrent radio-chemotherapy (CCRT) (Vissink, Burlage, Spijkervet, Jansma, \& Coppes, 2003; Lazarus et al., 2014). The consequences of multi-treatment bring structural and functional changes in oral, pharynx, or larynx and influence the normal eating process (Logemann et al., 2006; Lazarus et al., 2013; Patterson, McColl, Wilson, Carding, Rapley, 2015; McLaughlin, 2014).
Primary outcomes (6)
- measure
- Change in the Chewing Swallowing Inventory (CSI)
- timeFrame
- Patients will be recruited and assessed in 6 time points: before first CCRT (T1) and 4weeks, 8 week, 12 week , 6 month, and 12 month from CCRT (T2~T6).
- description
- This questionnaire is used to assess HNC patients' eating difficulties. CSI is a 21-item 5-point Likert's scale. The items represent the alteration of oral mucus, intake condition (abilities to chew, opening mouth, smelling, tasting, and tongue movement, and time spending for intake), and assistance for maintaining patients' independence. The score range of CSI is from 0 to 84. The higher score indicates the more severe difficulty of swallowing and intake. After revised the CSI content regarding the responses from 30 head-and-neck cancer patients, twenty-one items in the CSI were selected if the Index of Content Validity (CVI) were 0.86 or higher, and Cronbach's alpha was 0.91.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * diagnosed with head and neck cancer * patients with concurrent chemo-radiotherapy (CCRT) Exclusion Criteria: * primary unknown * conscious unclear * recurrence or with bone meta
References
Publications (19)
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