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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
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.
St. John Health System
Tulsa, Oklahoma, United States
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.
Time frame: through study completion, an average of 2 years
Patient loss of speech increase or decrease
Measure functional status of speech therapy every 30 days
Time frame: through study completion, an average of 2 years
Patient loss of swallow function increase or decrease
EORTC QLO - H\&N35 Questionnaire
Time frame: through study completion, an average of 2 years
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
Time frame: through study completion, an average of 2 years
Maintaining swallowing function
Speech therapy
Time frame: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
Assess Quality of Life
Time frame: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Assess Quality of Life
Time frame: through study completion, an average of 2 years
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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.
30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.
35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.