Nutrition Education Program for Cancer Patients Receiving Radiotherapy

Study Overview
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Brief Summary
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Using randomized control study, explore the effect of novel nutrition education program on the nutrition status and life quality of cancer patients receiving radiotherapy

Detailed Description
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Weight loss is common among cancer patients, and can be attributed to many causes, including mucositis, inability to ingest or absorb adequate calories because of a problem with the alimentary tract, loss of appetite, and metabolic aberrations. Unintentional weight loss may be associated with decreased quality of life (QOL) and a poorer prognosis. Furthermore, for patients who are already in a catabolic state, the increased metabolic demands associated with anticancer treatment (particularly surgery) further worsen the problem. The novel nutrition program might improve the nutrition status and QOL in cancer patients receiving radiotherapy.

Official Title
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The Effect of Nutrition Education Program on the Nutrition Status and Life Quality of Cancer Patients Receiving Radiotherapy

Conditions
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Radiotherapy Side Effect, Nutrition Related Cancer

Intervention / Treatment
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* Procedure: novel nutrition program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are diagnosed with cancer and receive radiotherapy, especially in head and neck cancer, lung cancer, or esophageal cancer. Patients need nutrition support treatment Informed consent Exclusion Criteria: Critical patients or life expectancy < 12 weeks Patients with severe hepatic cirrhosis, Chronic Obstructive Pulmonary Disease, chronic renal failure, intestinal obstruction, stroke. Unconscious or psychiatric patients Patients with communication problems

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single blind (Participant)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Novel nutrition program : Give nutrition health education every week and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease. | Procedure: novel nutrition program<br>* Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.<br>|
| Active Comparator: Arm B<br>Routine nutrition education Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients. | Procedure: novel nutrition program<br>* Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of malnutrition | Nutrition Risk Screening 2002 is used to assess the risk of malnutrition. | Week 0, 12 | 
| BMI | Body mass index is a measure of body fat based on height and weight that applies to adult men and women. It equals to weight divided by height square. | Week 0, 12 | 
| albumin | level of serum albumin | Week 0, 12 | 
| Quality of Life (QOL) | The QOL was measured by the European Organization for Research and Treatment quality of life version 3 questionnaire (EORTC QLQ-C30) simplified Chinese version. It contains five functional scales (physical, role, cognitive, emotional, and social), three symptoms scales (fatigue, pain, and nausea and vomiting), a global health scale, a number of single items assessing additional symptoms commonly reported by cancer patients (dyspnea, appetite loss, insomnia, constipation, and diarrhea) and financial impact of the disease. For most items, four response categories from 1 (not at all) to 4 (very much) are employed; two items (overall health, overall quality of life) have response categories ranging from 1 to 7. A high scale score represents a higher response level. Thus a high score for a functional scale, the global health status or overall QOL represents a high or healthy status or a high QOL; however, a high score for the symptom scales represents a high level of symptom. | Week 0, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical function status | Using Eastern Cooperative Oncology Group to assess the physical function. | Week 0, 12 | 
| Knowledge-Attitude-Practice | Knowledge Scale composes of 10 questions and 10 scores for each question. Attitude and Practice Scale have 5 questions. Each question is rated as A、B、C. A represents 20 score and B is 10 score. | Week 0, 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutrition, radiotherapy, cancer patients