Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
NCT ID: NCT02775721
Last Updated: 2018-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-07-31
2018-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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St. John Health System, Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Candida Barlow, MSN RN
Role: PRINCIPAL_INVESTIGATOR
St. John Health System
Locations
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St. John Health System
Tulsa, Oklahoma, United States
Countries
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Other Identifiers
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G-Tube
Identifier Type: -
Identifier Source: org_study_id
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