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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03883152
• Other study ID #: 201703066RIND
• Status: Completed
• Start date: June 27, 2017
• Est. completion date: August 7, 2020

Study information

• Verified date: December 2019
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: August 7, 2020
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
Taiwan	Yeur-Hur Lai	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (19)

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Chen SC, Lai YH, Liao CT, Chang JT, Lin CY, Fan KH, Huang BS. Supportive care needs in newly diagnosed oral cavity cancer patients receiving radiation therapy. Psychooncology. 2013 Jun;22(6):1220-8. doi: 10.1002/pon.3126. Epub 2012 Jun 25. — View Citation

Chen SC, Lai YH, Liao CT, Lin CC, Chang JT. Changes of symptoms and depression in oral cavity cancer patients receiving radiation therapy. Oral Oncol. 2010 Jul;46(7):509-13. doi: 10.1016/j.oraloncology.2010.02.024. Epub 2010 Mar 21. — View Citation

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Lazarus CL, Husaini H, Anand SM, Jacobson AS, Mojica JK, Buchbinder D, Urken ML. Tongue strength as a predictor of functional outcomes and quality of life after tongue cancer surgery. Ann Otol Rhinol Laryngol. 2013 Jun;122(6):386-97. — View Citation

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Logemann JA, Rademaker AW, Pauloski BR, Lazarus CL, Mittal BB, Brockstein B, MacCracken E, Haraf DJ, Vokes EE, Newman LA, Liu D. Site of disease and treatment protocol as correlates of swallowing function in patients with head and neck cancer treated with chemoradiation. Head Neck. 2006 Jan;28(1):64-73. — View Citation

McLaughlin L. Taste dysfunction and eating behaviors in survivors of head and neck cancer treatment. Medsurg Nurs. 2014 May-Jun;23(3):165-70, 184. — View Citation

Patterson JM, McColl E, Wilson J, Carding P, Rapley T. Head and neck cancer patients' perceptions of swallowing following chemoradiotherapy. Support Care Cancer. 2015 Dec;23(12):3531-8. doi: 10.1007/s00520-015-2715-8. Epub 2015 Apr 8. — View Citation

Tsai AC, Chang TL, Wang YC, Liao CY. Population-specific short-form mini nutritional assessment with body mass index or calf circumference can predict risk of malnutrition in community-living or institutionalized elderly people in taiwan. J Am Diet Assoc. 2010 Sep;110(9):1328-34. doi: 10.1016/j.jada.2010.06.003. — View Citation

Tsai AC, Ho CS, Chang MC. Assessing the prevalence of malnutrition with the Mini Nutritional Assessment (MNA) in a nationally representative sample of elderly Taiwanese. J Nutr Health Aging. 2008 Apr;12(4):239-43. — View Citation

Tsai AC, Hsu WC, Chan SC, Chang TL. Usefulness of the mini nutritional assessment in predicting the nutritional status of patients with liver cancer in Taiwan. Nutr Cancer. 2011;63(3):334-41. doi: 10.1080/01635581.2011.535966. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Chewing Swallowing Inventory (CSI)	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.	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).
Primary	Change in The Mini Nutritional Assessment (MNA)	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).	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).
Primary	Change in the Depression Subscale of Hospital Anxiety and Depression Scale (HADS-D)	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).	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).
Primary	Change in the Symptom Severity Scale (SSS)	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).	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).
Primary	Change in the Background Information Form	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.	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).
Primary	Change in the Hand Dynamometer Evaluation	We will use the hand dynamometer to assess HNC patients' hands' grip power. It will represent the general energy level of the patient.	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).