Gastrostomy, Malnutrition
Conditions
Keywords
Nursing Education, Weight Loss, Gastrostomy Tube Care
Brief summary
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
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.
Interventions
OTHERNursing Education related to Gastrostomy Tube Care
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
OTHERSpeech Therapy Education and Evaluation
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.
OTHERNutritional 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.
OTHERQuality of Life Questionnaire C30 version 3
30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.
OTHERQuality of Life Questionnaire EORTC QLO - H&N35
35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.
Sponsors
St. John Health System, Oklahoma
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment. | 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 | 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 | through study completion, an average of 2 years | EORTC QLO - H&N35 Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient knowledge of management and care of Gastrostomy Tube. | through study completion, an average of 2 years | Nursing Education utilizing the Gastrostomy Tube education booklet will improve patient's knowledge and management of Gastrostomy Tube care |
| Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire. | through study completion, an average of 2 years | Assess Quality of Life |
| Maintaining swallowing function | through study completion, an average of 2 years | Speech therapy |
| Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire. | through study completion, an average of 2 years | Assess Quality of Life |
Countries
United States
Outcome results
None listed