Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
研究概览
简要总结
Poor nutritional status and malnutrition are prevalent for patients undergoing treatment for head and neck cancer. Inadequate dietary intake is multi factorial, with patients experiencing dysphagia and or anorexia caused by various cancer treatments. Current standard practice utilizes Gastrostomy Tube placement to manage adverse nutritional effects related to Head and Neck cancer treatment.
详细描述
The purpose of this study is to assess the quality of life and educational intervention outcomes of Head and Neck Cancer patients who have a gastrostomy tube placed per standard of care.
A high incident of Gastrostomy tube replacement occurs related to clogged, dislodged, and/or pulled out tubes. In addition, patients not eating or drinking after Gastrostomy tube placement, compounded by complications related to radiation treatment, results in decreased swallowing function. Inadequate swallow function, especially when combined with inadequate use of Gastrostomy tube, due to non-functional tube or insufficient patient knowledge in use of tube, results in poor nutritional status and excessive weight loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Head and Neck cancer diagnosis
- •Esophageal cancer diagnosis
- •Receiving chemotherapy and/or radiation therapy
- •Gastrostomy Tube placed within the last 30days or scheduled to have a gastrostomy tube placed within the next 30 days
排除标准
- •Not eligible for chemotherapy and/or radiation therapy
- •Unwilling or unable to sign informed consent
- •Any cognitive or mental deficits that would prevent patient from completing questionnaires or understanding educational interventions
- •Current pre-existing Gastrostomy tube complications if a current Gastrostomy tube is in place prior to informed consent (i.e., skin breakdown, tube breakdown, other tube complications).
- •No Gastrostomy tube placement
- •Non-English Speaking
研究组 & 干预措施
Cohort C
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nursing Education related to Gastrostomy Tube Care (Other)
Cohort C
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Speech Therapy Education and Evaluation (Other)
Cohort C
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nutritional Therapy Education and Evaluation (Other)
Cohort C
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire C30 version 3 (Other)
Cohort C
Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire EORTC QLO - H&N35 (Other)
Cohort A
Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nursing Education related to Gastrostomy Tube Care (Other)
Cohort A
Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Speech Therapy Education and Evaluation (Other)
Cohort A
Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nutritional Therapy Education and Evaluation (Other)
Cohort A
Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire C30 version 3 (Other)
Cohort A
Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire EORTC QLO - H&N35 (Other)
Cohort B
Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nursing Education related to Gastrostomy Tube Care (Other)
Cohort B
Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Speech Therapy Education and Evaluation (Other)
Cohort B
Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Nutritional Therapy Education and Evaluation (Other)
Cohort B
Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire C30 version 3 (Other)
Cohort B
Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C.
Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process.
Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist.
Nutritional therapy education and evaluation is assessed per the attending dietitian.
The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.
干预措施: Quality of Life Questionnaire EORTC QLO - H&N35 (Other)
结局指标
主要结局
Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
时间窗: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H\&N35 Questionnaires.
Patient loss of speech increase or decrease
时间窗: through study completion, an average of 2 years
Measure functional status of speech therapy every 30 days
Patient loss of swallow function increase or decrease
时间窗: through study completion, an average of 2 years
EORTC QLO - H\&N35 Questionnaire
次要结局
- Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.(through study completion, an average of 2 years)
- Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.(through study completion, an average of 2 years)
- Maintaining swallowing function(through study completion, an average of 2 years)
- Patient knowledge of management and care of Gastrostomy Tube.(through study completion, an average of 2 years)