Eating Difficulties in HNC Patients - Influencing Factors and Short and Long Term Impacts on PF and Depression

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03883152

Collaborator

(none)

131

Enrollment

Location

37.4

Actual Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer

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.

Study Design

Study Type:

Observational

Actual Enrollment :

131 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 27, 2017

Actual Primary Completion Date :

Aug 7, 2020

Actual Study Completion Date :

Aug 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Head and neck cancer 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).

Arm

Intervention/Treatment

Head and neck cancer

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).

Outcome Measures

Primary Outcome Measures

Change in the Chewing Swallowing Inventory (CSI) [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).]
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.
Change in The Mini Nutritional Assessment (MNA) [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).]
MNA is a validated tool consisted of nutrition screening and general assessment to early detect the malnourished geriatric patients who are age at 65 and older (Guigoz, Vellas, & Garry, 1996). The total score of the MNA is 30. The cut-off point to distinguish the elder's nutrition was in three types: a) MNA ≥ 24 indicating an adequate nutritional status, b) MNA between 17 and 23.5 indicating a risk of malnutrition, and c) MNA < 17 indicating protein-calorie malnutrition. With these cut points, sensitivity was found to be 96%, specificity 98%, and predictive value 97% (Vella, Guigoz, & Garry, et al, 1999). Satisfactory reliability and validity of the MNA-Chinese version has been validated to assess nutrition for the elder in Taiwan (Tsai, Ho, & Chang, 2008; Tsai, Change, Wang, & Liao, 2010), and to assess nutrition of patients with liver cancer (Hsu, Tsai, Chan, Wang, & Chung, 2012; Tsai, Hsu, Chan, & Chang, 2011).
Change in the Depression Subscale of Hospital Anxiety and Depression Scale (HADS-D) [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).]
We will use 14-item HADS to assess patients' anxiety and depression (Zigmond & Snaith, 1983). The HADS has 7 items that measure anxiety and 7 that measure depression. The total score of each subscale is ranged from 0 to 21 with a higher score indicating a higher level of anxiety and depression. The Taiwanese version of HADS has been developed and validated showed promising psychometrics (Chen et al., 2010; Cheng, Hao, Lin, & Yeh, 2000).
Change in the Symptom Severity Scale (SSS) [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' symptom severity was measured by the Symptom Severity Scale, and that was developed and modified to determine treatment-related symptoms in head and neck cancer patients (Chen et al., 2010). The 20-item SSS contains items related to swallowing difficulty, eating difficulty, oral mucositis, speech difficulty, fatigue, poor appetite, pain, cough, apnea, constipation, diarrhea, nausea, and vomiting. Each item is rated on an 11-point scale of 0 to 10, with 0 indicating "no such symptom at all" and 10 indicating "extreme severity of the symptom." The SSS has been demonstrated to be a reliable scale in oral cancer-related studies in Taiwan, with Cronbach's alpha coefficients ranging from 0.82 to 0.91 (Chen et al., 2010; Chen et al., 2013).
Change in the Background Information Form [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).]
Background Information Form displays participants' characteristics. Patients' demographics describe age, sex, and marital status. Patients' clinical characteristics, which are categorical variables, show cancer diagnoses, stages, recurrence, categories and time of treatments for HNC cancer, and reconstruction within surgery.
Change in the Hand Dynamometer Evaluation [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).]
We will use the hand dynamometer to assess HNC patients' hands' grip power. It will represent the general energy level of the patient.