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

Malnutrition Clinical Trial

— G-Tube  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02775721
• Other study ID #: G-Tube
• Status: Active, not recruiting
• Phase: N/A
• First received: September 23, 2015
• Last updated: April 16, 2018
• Start date: July 2015
• Est. completion date: December 2018

Study information

• Verified date: April 2018
• Source: St. John Health System, Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrostomy
• Head and Neck Neoplasms
• Malnutrition
• Weight Loss

Intervention

Other:
• Nursing Education related to Gastrostomy Tube Care
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	St. John Health System	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
St. John Health System, Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 2 years
Primary	Patient loss of speech increase or decrease	Measure functional status of speech therapy every 30 days	through study completion, an average of 2 years
Primary	Patient loss of swallow function increase or decrease	EORTC QLO - H&N35 Questionnaire	through study completion, an average of 2 years
Secondary	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	through study completion, an average of 2 years
Secondary	Maintaining swallowing function	Speech therapy	through study completion, an average of 2 years
Secondary	Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.	Assess Quality of Life	through study completion, an average of 2 years
Secondary	Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.	Assess Quality of Life	through study completion, an average of 2 years