Eating Difficulties in HNC Patients - Influencing Factors and Short and Long Term Impacts on PF and Depression
NCT ID: NCT03883152
Last Updated: 2020-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
131 participants
OBSERVATIONAL
2017-06-27
2020-08-07
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patients with concurrent chemo-radiotherapy (CCRT)
Exclusion Criteria
* conscious unclear
* recurrence or with bone meta
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Responsible Party
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Principal Investigators
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Yeur-Hur Lai, Professor
Role: STUDY_CHAIR
School of Nursing, College of Medicine, National Taiwan University
Locations
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Yeur-Hur Lai
Taipei, , Taiwan
Countries
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References
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Guigoz Y, Vellas B, Garry PJ. Assessing the nutritional status of the elderly: The Mini Nutritional Assessment as part of the geriatric evaluation. Nutr Rev. 1996 Jan;54(1 Pt 2):S59-65. doi: 10.1111/j.1753-4887.1996.tb03793.x. No abstract available.
Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.
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. doi: 10.1007/BF02982628.
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.
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.
Hsu WC, Tsai AC, Chan SC, Wang PM, Chung NN. Mini-nutritional assessment predicts functional status and quality of life of patients with hepatocellular carcinoma in Taiwan. Nutr Cancer. 2012;64(4):543-9. doi: 10.1080/01635581.2012.675620. Epub 2012 Apr 20.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
Herrmann C. International experiences with the Hospital Anxiety and Depression Scale--a review of validation data and clinical results. J Psychosom Res. 1997 Jan;42(1):17-41. doi: 10.1016/s0022-3999(96)00216-4.
Lloyd-Williams M, Friedman T, Rudd N. An analysis of the validity of the Hospital Anxiety and Depression scale as a screening tool in patients with advanced metastatic cancer. J Pain Symptom Manage. 2001 Dec;22(6):990-6. doi: 10.1016/s0885-3924(01)00358-x.
Chen ML, Chang HK, Yeh CH. Anxiety and depression in Taiwanese cancer patients with and without pain. J Adv Nurs. 2000 Oct;32(4):944-51.
Chen SC, Lai YH, Liao CT, Lin CC. Psychometric testing of the Impact of Event Scale-Chinese Version (IES-C) in oral cancer patients in Taiwan. Support Care Cancer. 2005 Jul;13(7):485-92. doi: 10.1007/s00520-005-0775-x. Epub 2005 Feb 17.
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.
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.
Vissink A, Burlage FR, Spijkervet FK, Jansma J, Coppes RP. Prevention and treatment of the consequences of head and neck radiotherapy. Crit Rev Oral Biol Med. 2003;14(3):213-25. doi: 10.1177/154411130301400306.
Lazarus CL, Husaini H, Hu K, Culliney B, Li Z, Urken M, Jacobson A, Persky M, Tran T, Concert C, Palacios D, Metcalfe-Klaw R, Kumar M, Bennett B, Harrison L. Functional outcomes and quality of life after chemoradiotherapy: baseline and 3 and 6 months post-treatment. Dysphagia. 2014 Jun;29(3):365-75. doi: 10.1007/s00455-014-9519-8. Epub 2014 Mar 8.
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. doi: 10.1177/000348941312200608.
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. doi: 10.1002/hed.20299.
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.
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.
Other Identifiers
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201703066RIND
Identifier Type: -
Identifier Source: org_study_id
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