Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement (G-Tube)

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.

Study Overview

• Status: Unknown
• Conditions: Malnutrition; Gastrostomy
• Intervention / Treatment: Other: Nursing Education related to Gastrostomy Tube Care; Other: Speech Therapy Education and Evaluation; Other: Nutritional Therapy Education and Evaluation; Other: Quality of Life Questionnaire C30 version 3; Other: Quality of Life Questionnaire EORTC QLO - H&N35

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • St. John Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Cohort A; Head and Neck Cancer patients receiving Radiation Therapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts B and C. Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process. Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist. Nutritional therapy education and evaluation is assessed per the attending dietitian. The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.	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.
Other: Cohort B; Head and Neck Cancer patients receiving Chemotherapy Only. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and C. Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process. Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist. Nutritional therapy education and evaluation is assessed per the attending dietitian. The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.	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.
Other: Cohort C; Head and Neck Cancer patients receiving Chemotherapy and Radiation therapy. The purpose is to do a comparative analysis and identify if patient quality of life outcomes are the same, better or worse when compared to Cohorts A and B. Interventions: The research nurse will provide gastrostomy tube care education and skin care education at each study visit utilizing the nursing process. Speech therapy education and evaluation is assessed per standard of care by the attending speech therapist. Nutritional therapy education and evaluation is assessed per the attending dietitian. The European Organization for Research and Treatment of Cancer (EORTC) head and neck cancer module (QLQ-H&N35) and EORTC Core Questionnaire (QLQ-C30) version 3.0 will be completed by the subject.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient loss of speech increase or decrease	Measure functional status of speech therapy every 30 days	through study completion, an average of 2 years
Patient loss of swallow function increase or decrease	EORTC QLO - H&N35 Questionnaire	through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Maintaining swallowing function	Speech therapy	through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.	Assess Quality of Life	through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.	Assess Quality of Life	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: St. John Health System, Oklahoma
• Investigators: Principal Investigator: Candida Barlow, MSN RN, St. John Health System

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: May 13, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Weight Loss; Nursing Education; Gastrostomy Tube Care
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Nutrition Disorders; Body Weight; Body Weight Changes; Head and Neck Neoplasms; Weight Loss; Malnutrition
• Other Study ID Numbers: G-Tube

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED