Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
G-Tube
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 23, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedApril 17, 2018
April 1, 2018
3.4 years
September 23, 2015
April 16, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (4)
Patient knowledge of management and care of Gastrostomy Tube.
through study completion, an average of 2 years
Maintaining swallowing function
through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
through study completion, an average of 2 years
Study Arms (3)
Cohort A
OTHERHead 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.
Cohort B
OTHERHead 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.
Cohort C
OTHERHead 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.
Interventions
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
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 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.
30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.
35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. John Health System
Tulsa, Oklahoma, 74104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candida Barlow, MSN RN
St. John Health System
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2015
First Posted
May 18, 2016
Study Start
July 1, 2015
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
April 17, 2018
Record last verified: 2018-04