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

Not Applicable

• Conditions: Gastrostomy; Malnutrition

• Registration Number: NCT02775721
• Lead Sponsor: St. John Health System, Oklahoma

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2016-05-13
• Study First Posted: 2016-05-18
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-17
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 QLQ-C30 version 3 Questionnaire.	through study completion, an average of 2 years	Assess Quality of Life
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

Trial Locations

Locations (1)

St. John Health System; 🇺🇸 Tulsa, Oklahoma, United States