Clinical trial NCT03883152: Eating Difficulties in HNC Patients - Influencing Factors and Short and Long Term Impacts on PF and Depression
Official title: Yeur-Hur Lai, PhD, RN, School of Nursing, College of Medicine, National Taiwan University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: Eating Difficulties
Chewing
Swallowing
Head and neck cancer
Depression
Physical function
Nutrition
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 131
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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) (Kendall, 2008; Vissink, Burlage, Spijkervet, Jansma, \& Coppes, 2003; Lazarus, Husaini, Hu,...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 CL, Husaini H, Anand,...et al., 2013; Patterson, McColl, Wilson, Carding, Rapley, 2015; McLaughlin, 2014).

Brief 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.

Detailed description: This is a longitudinal study which aims to examine the short- and long-term eating difficulties, its related factors and its impacts. The participants will be recruited in the outpatient department of Ear, Nose, and Throat (ENT) in NTUH. The inclusion criteria are (a) diagnosed as head and neck cancer; (b) will be received cancer treatments including surgery and CCRT; (c) age is 20 or older. The exclusion criteria are (a) the patient is inserted a plastic tube, e.g. nasogastric tube (NG) or percutaneous endoscopic gastrostomy tube (PEG), for feeding; (b) patients could not understand the content of questionnaires. The investigators will recruit 100 subjects with complete 12-month data. Concerning 25% patients loss rate, the investigators will recruit 125 subjects at the beginning of the first year.

Patients will be assessed by Chewing Swallowing Inventory (CSI), Mini Nutritional Assessment (MNA), Depression subscale of Hospital Anxiety and Depression Scale (HADS), Symptom Severity Scale (SSS), 0-10 general Fatigue severity numerical scale, and disease and treatment background Information Form (BIF). Grip power of dominant hand will be assessed by hand dynamometer.

Eligibility criteria: 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

Primary outcomes:
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).
measure: Change in The Mini Nutritional Assessment (MNA)
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).
measure: Change in the Depression Subscale of Hospital Anxiety and Depression Scale (HADS-D)
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).
measure: Change in the Symptom Severity Scale (SSS)
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).
measure: Change in the Background Information Form
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).
measure: Change in the Hand Dynamometer Evaluation
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).
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yeur-Hur Lai
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Yeur-Hur Lai, Professor
role: STUDY_CHAIR
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