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

Primary Purpose

Malnutrition, Gastrostomy

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nursing Education related to Gastrostomy Tube Care
Speech Therapy Education and Evaluation
Nutritional Therapy Education and Evaluation
Quality of Life Questionnaire C30 version 3
Quality of Life Questionnaire EORTC QLO - H&N35
Sponsored by
St. John Health System, Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malnutrition focused on measuring Nursing Education, Weight Loss, Gastrostomy Tube Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. John Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
Patient loss of speech increase or decrease
Measure functional status of speech therapy every 30 days
Patient loss of swallow function increase or decrease
EORTC QLO - H&N35 Questionnaire

Secondary Outcome Measures

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
Maintaining swallowing function
Speech therapy
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
Assess Quality of Life
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Assess Quality of Life

Full Information

First Posted
September 23, 2015
Last Updated
April 16, 2018
Sponsor
St. John Health System, Oklahoma
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1. Study Identification

Unique Protocol Identification Number
NCT02775721
Brief Title
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
Acronym
G-Tube
Official Title
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2015 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. John Health System, Oklahoma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Gastrostomy
Keywords
Nursing Education, Weight Loss, Gastrostomy Tube Care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Other
Arm Description
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.
Arm Title
Cohort B
Arm Type
Other
Arm Description
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.
Arm Title
Cohort C
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nursing Education related to Gastrostomy Tube Care
Intervention Description
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
Intervention Type
Other
Intervention Name(s)
Speech Therapy Education and Evaluation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Nutritional Therapy Education and Evaluation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaire C30 version 3
Intervention Description
30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.
Intervention Type
Other
Intervention Name(s)
Quality of Life Questionnaire EORTC QLO - H&N35
Intervention Description
35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.
Primary Outcome Measure Information:
Title
Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
Description
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H&N35 Questionnaires.
Time Frame
through study completion, an average of 2 years
Title
Patient loss of speech increase or decrease
Description
Measure functional status of speech therapy every 30 days
Time Frame
through study completion, an average of 2 years
Title
Patient loss of swallow function increase or decrease
Description
EORTC QLO - H&N35 Questionnaire
Time Frame
through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Patient knowledge of management and care of Gastrostomy Tube.
Description
Nursing Education utilizing the Gastrostomy Tube education booklet will improve patient's knowledge and management of Gastrostomy Tube care
Time Frame
through study completion, an average of 2 years
Title
Maintaining swallowing function
Description
Speech therapy
Time Frame
through study completion, an average of 2 years
Title
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
Description
Assess Quality of Life
Time Frame
through study completion, an average of 2 years
Title
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Description
Assess Quality of Life
Time Frame
through study completion, an average of 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candida Barlow, MSN RN
Organizational Affiliation
St. John Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. John Health System
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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