Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

Conditions
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Malnutrition, Gastrostomy

Intervention / Treatment
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* Other: Nursing Education related to Gastrostomy Tube Care
* Other: Speech Therapy Education and Evaluation
* Other: Nutritional Therapy Education and Evaluation
* Other: Quality of Life Questionnaire C30 version 3
* Other: Quality of Life Questionnaire EORTC QLO - H&N35


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cohort A<br>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. | Other: Nursing Education related to Gastrostomy Tube Care<br>* The research nurse will provide educational intervention at each study visit utilizing the nursing process.<br>Other: Speech Therapy Education and Evaluation<br>* Speech therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Speech therapy and evaluation is assessed per the attending speech therapist. The study team will collect all data related to speech therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Nutritional Therapy Education and Evaluation<br>* Nutritional therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Nutritional therapy and evaluation is assessed per the attending dietitian. The study team will collect all data related to nutritional therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Quality of Life Questionnaire C30 version 3<br>* 30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.<br>Other: Quality of Life Questionnaire EORTC QLO - H&N35<br>* 35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.<br>|
| Other: Cohort B<br>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. | Other: Nursing Education related to Gastrostomy Tube Care<br>* The research nurse will provide educational intervention at each study visit utilizing the nursing process.<br>Other: Speech Therapy Education and Evaluation<br>* Speech therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Speech therapy and evaluation is assessed per the attending speech therapist. The study team will collect all data related to speech therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Nutritional Therapy Education and Evaluation<br>* Nutritional therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Nutritional therapy and evaluation is assessed per the attending dietitian. The study team will collect all data related to nutritional therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Quality of Life Questionnaire C30 version 3<br>* 30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.<br>Other: Quality of Life Questionnaire EORTC QLO - H&N35<br>* 35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.<br>|
| Other: Cohort C<br>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. | Other: Nursing Education related to Gastrostomy Tube Care<br>* The research nurse will provide educational intervention at each study visit utilizing the nursing process.<br>Other: Speech Therapy Education and Evaluation<br>* Speech therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Speech therapy and evaluation is assessed per the attending speech therapist. The study team will collect all data related to speech therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Nutritional Therapy Education and Evaluation<br>* Nutritional therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Nutritional therapy and evaluation is assessed per the attending dietitian. The study team will collect all data related to nutritional therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.<br>Other: Quality of Life Questionnaire C30 version 3<br>* 30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.<br>Other: Quality of Life Questionnaire EORTC QLO - H&N35<br>* 35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment. | Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H&N35 Questionnaires. | through study completion, an average of 2 years | 
| Patient loss of speech increase or decrease | Measure functional status of speech therapy every 30 days | through study completion, an average of 2 years | 
| Patient loss of swallow function increase or decrease | EORTC QLO - H&N35 Questionnaire | through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient knowledge of management and care of Gastrostomy Tube. | Nursing Education utilizing the Gastrostomy Tube education booklet will improve patient's knowledge and management of Gastrostomy Tube care | through study completion, an average of 2 years | 
| Maintaining swallowing function | Speech therapy | through study completion, an average of 2 years | 
| Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire. | Assess Quality of Life | through study completion, an average of 2 years | 
| Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire. | Assess Quality of Life | through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nursing Education, Weight Loss, Gastrostomy Tube Care