Children With Cancer Clinical Trial
Official title:
The Effectiveness of Mukbang in Helping Children With Cancer Hospitalized for Radiotherapy and Chemotherapy to Improve Appetite, Nutritional Status and Quality of Life: A Randomized Control Trial
This study aims to use a three arms randomized clinical trial study to evaluate the effectiveness of the effective constituent of Mukbang in helping children with cancer hospitalized for radiotherapy and chemotherapy to improve their appetite, nutritional status and quality of life.
Status | Not yet recruiting |
Enrollment | 114 |
Est. completion date | May 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: - Aged between 6 to 18 years old; - Children in accordance with the guidelines for the Diagnosis and Treatment of 12 Diseases related to hematologic diseases and malignant tumors (2021 version) issued by the General Office of the National Health Commission; - At least experience one full cycle of chemotherapy; - Children with moderate or higher symptoms of decreased appetite were screened for a list of treatment-related symptoms. Exclusion Criteria: - Children with serious cardiopulmonary disease, infection, organ damage, or genetic metabolic disease, immune deficiency disease, mental illness; - Children with eye or ear dysfunction that prevents them from watching and listening to videos. |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Wei XIA, PhD |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Self-reported appetite during the intervention | A subjective sensation that stimulates the intake of food to provide the energy necessary for the most basic activities of life, which can be measured by the Cancer Appetite and Symptom Questionnaire (CASQ). | Change from baseline appetite during 5 days intervention | |
Primary | Self-reported appetite during the intervention | A subjective sensation that stimulates the intake of food to provide the energy necessary for the most basic activities of life, which can be measured by the Cancer Appetite and Symptom Questionnaire (CASQ). | Change from baseline appetite at 3 weeks follow-up | |
Secondary | The level of nutritional status | Insufficient or excessive nutrient intake, imbalance of essential nutrients or impaired nutrient utilization, mainly manifested by wasting, stunting, underweight and micronutrient deficiency. Malnutrition is measured by the Subjective Global Nutritional Risk Assessment (SGNA). | Change from baseline nutritional status at 5 days | |
Secondary | The level of nutritional status | Insufficient or excessive nutrient intake, imbalance of essential nutrients or impaired nutrient utilization, mainly manifested by wasting, stunting, underweight and micronutrient deficiency. Malnutrition is measured by the Subjective Global Nutritional Risk Assessment (SGNA). | Change from baseline nutritional status at 3-weeks follow-up | |
Secondary | The level of the body mass index of the children with cancer | Body mass index (BMI), a simple method to evaluate the nutritional status and changes of children with cancer, which will be calculated as weight/height^2. Weight and height will be combined to report BMI in kg/m^2. | Change from baseline BMI at 5 days | |
Secondary | The level of the body mass index of the children with cancer | Body mass index (BMI), a simple method to evaluate the nutritional status and changes of children with cancer, which will be calculated as weight/height^2. Weight and height will be combined to report BMI in kg/m^2. | Change from baseline BMI at 3-weeks follow-up | |
Secondary | The quality of life after the intervention | Individuals in different cultures and value systems experience their living conditions in relation to their goals, expectations, standards and concerns, including their physical health, mental state, independence, social relations, personal beliefs and relationships with the surrounding environment. This target is measured by the pediatric quality of life inventory measurement models 3.0 (PedsQLTM-3.0-cancer). | Change from baseline quality of life at 5 days | |
Secondary | The quality of life after the intervention | Individuals in different cultures and value systems experience their living conditions in relation to their goals, expectations, standards and concerns, including their physical health, mental state, independence, social relations, personal beliefs and relationships with the surrounding environment. This target is measured by the pediatric quality of life inventory measurement models 3.0 (PedsQLTM-3.0-cancer). | Change from baseline quality of life at 3-weeks follow-up |
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