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Head and Neck CancerNCT03883152

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

An observational study of Head and Neck Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Head and Neck Cancer
Type of treatment
Pill or oral medicine
How many people
131 participants
Where
1 siteTaiwan
Study dates
27 Jun 2017to 7 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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).

Who may be able to join

  • diagnosed with head and neck cancer
  • patients with concurrent chemo-radiotherapy (CCRT)

Who cannot join

  • primary unknown
  • conscious unclear
  • recurrence or with bone meta

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Yeur-Hur Lai

    Taipei, 100

Other trials in Taiwan

About this study

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

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.

Read more

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.

Read the 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.

Keywords
Eating Difficulties, Chewing, Swallowing, Head and neck cancer, Depression, Physical function, Nutrition
Medical subject headings
Head and Neck Neoplasms, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03883152
Study groupRoleWhat they receive
Head and neck cancerEating 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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).

  2. 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).

    Measured: 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).

  3. 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).

    Measured: 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).

  4. 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).

    Measured: 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).

  5. 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.

    Measured: 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).

  6. 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.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2019
  2. Study start27 Jun 2017
  3. Primary completion7 Aug 2020
  4. Study completion7 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
131 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03883152
Sponsor's protocol ID
201703066RIND
Status last verified
Dec 2019
First submitted
3 Dec 2018
Last updated
11 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 8919685

  • 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.

    PubMed 9990575

  • 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.

    PubMed 18373032

  • 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.

    PubMed 20800124

  • 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.

    PubMed 21462083

  • 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.

    PubMed 22519878

  • 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.

    PubMed 6880820

  • 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.

    PubMed 9055211

  • 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.

    PubMed 11738161

  • 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.

    PubMed 11095234

  • 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.

    PubMed 15717159

  • 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.

    PubMed 20308004

  • 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.

    PubMed 22730021

  • 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.

    PubMed 12799324

  • 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.

    PubMed 24609609

Questions about this trial

What is this clinical trial studying?

An observational study of Head and Neck Cancer, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Chewing Swallowing Inventory (CSI) (time frame: 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).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03883152, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.

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