NCT02775721

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: St. John Health System, Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malnutrition
• Gastrostomy

Interventions

Type	Name	Description
OTHER	Nursing Education related to Gastrostomy Tube Care	The research nurse will provide educational intervention at each study visit utilizing the nursing process.
OTHER	Speech 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.
OTHER	Nutritional 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.
OTHER	Quality 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.
OTHER	Quality 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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2018-12-01
• Completion: 2018-12-01
• First posted: 2016-05-18
• Last updated: 2018-04-17

Locations

1 site across 1 country: United States