Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Neoplasms

Weight Loss

Malnutrition

Head and Neck Neoplasms

Body Weight

Body Weight Changes

Nutrition Disorders

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.

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.

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.

The research nurse will provide educational intervention at each study visit utilizing the nursing process.

Nursing Education related to Gastrostomy Tube Care

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.

Speech Therapy Education and Evaluation

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.

Nutritional Therapy Education and Evaluation

30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.

Quality of Life Questionnaire C30 version 3

35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.

Quality of Life Questionnaire EORTC QLO - H&N35

Candida Barlow, MSN RN

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.

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.

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

Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H\&N35 Questionnaires.

Measure functional status of speech therapy every 30 days

Nursing Education utilizing the Gastrostomy Tube education booklet will improve patient's knowledge and management of Gastrostomy Tube care

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement	NCT02775721	Malnutrition Gastrostomy	Nursing Educati... Speech Therapy ... Nutritional The... Quality of Life... Quality of Life...	18 Years -	St. John Health System, Oklahoma
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement	NCT02775721	Malnutrition Gastrostomy	Nursing Educati... Speech Therapy ... Nutritional The... Quality of Life... Quality of Life...	18 Years -	St. John Health System, Oklahoma

Spots Global Cancer Trial Database for gastrostomy tube care