MalnutritionG-TubeNCT02775721
Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
A study testing Nursing Education related to Gastrostomy Tube Care, Speech Therapy Education and Evaluation and Nutritional Therapy Education and Evaluation in people with Malnutrition and Gastrostomy, run by St. John Health System, Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Gastrostomy
- What is being tested?
- Nursing Education related to Gastrostomy Tube Care, Speech Therapy Education and Evaluation and Nutritional Therapy Education and Evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Malnutrition, Gastrostomy
- Being tested
- 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
- Keywords
- Nursing Education, Weight Loss, Gastrostomy Tube Care
- Medical subject headings
- Malnutrition, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Education related to Gastrostomy Tube CareOther
The research nurse will provide educational intervention at each study visit utilizing the nursing process.
Speech Therapy Education and EvaluationOther
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 EvaluationOther
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 3Other
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&N35Other
35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Other | 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. Receives: 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 |
| Cohort B | Other | 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. Receives: 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 |
| Cohort C | Other | 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Patient loss of speech increase or decrease
Measure functional status of speech therapy every 30 days
Measured: through study completion, an average of 2 years
Patient loss of swallow function increase or decrease
EORTC QLO - H\&N35 Questionnaire
Measured: through study completion, an average of 2 years
Secondary outcomes (4)
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
Measured: through study completion, an average of 2 years
Maintaining swallowing function
Speech therapy
Measured: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
Assess Quality of Life
Measured: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Assess Quality of Life
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. John Health System, Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candida Barlow, MSN RN, Principal investigator, St. John Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775721
- Sponsor's protocol ID
- G-Tube
- Acronym
- G-Tube
- Status last verified
- Apr 2018
- First submitted
- 23 Sep 2015
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
- ClinicalTrials.gov ID
- NCT02775721
- Acronym / sponsor ID
- G-Tube / G-Tube
- Conditions
- Malnutrition, Gastrostomy
- Keywords
- Nursing Education, Weight Loss, Gastrostomy Tube Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. John Health System, OklahomaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Other | 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&N35Head 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 | Other | 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&N35Head 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 | Other | 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&N35Head 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Education related to Gastrostomy Tube CareThe research nurse will provide educational intervention at each study visit utilizing the nursing process. | Other | Cohort A, Cohort B, Cohort C |
| Speech Therapy Education and EvaluationSpeech 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 | Cohort A, Cohort B, Cohort C |
| Nutritional Therapy Education and EvaluationNutritional 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 | Cohort A, Cohort B, Cohort C |
| Quality of Life Questionnaire C30 version 330-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations. | Other | Cohort A, Cohort B, Cohort C |
| Quality of Life Questionnaire EORTC QLO - H&N3535-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations. | Other | Cohort A, Cohort B, Cohort C |
Primary outcome
Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
Time frame: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 and EORTC QLO - H\&N35 Questionnaires.
Patient loss of speech increase or decrease
Time frame: through study completion, an average of 2 years
Measure functional status of speech therapy every 30 days
Patient loss of swallow function increase or decrease
Time frame: through study completion, an average of 2 years
EORTC QLO - H\&N35 Questionnaire
4 secondary outcomes
Patient knowledge of management and care of Gastrostomy Tube.
Time frame: through study completion, an average of 2 years
Maintaining swallowing function
Time frame: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
Time frame: through study completion, an average of 2 years
Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candida Barlow, MSN RN principal investigator
St. John Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Education related to Gastrostomy Tube Care, Speech Therapy Education and Evaluation and Nutritional Therapy Education and Evaluation in people with Malnutrition and Gastrostomy, run by St. John Health System, Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment. (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.