CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 131 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT03883152
NCT03883152N/ACompleted

Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University

National Taiwan University Hospital·observational·Posted Mar 20, 2019·Updated Aug 11, 2020

In Brief

An observational study for Head and Neck Cancer. Completed, enrolled 131 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 20, 2019
Enrollment StartJun 27, 2017
Primary CompletionAug 7, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.3 years ago