Clinical trial NCT02775721: Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
Official title: Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malnutrition
Gastrostomy
Keywords: Nursing Education
Weight Loss
Gastrostomy Tube Care
Lead sponsor: St. John Health System, Oklahoma
Sponsor class: OTHER
First posted: 2016-05-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Sustained ± 10% body weight post gastrostomy tube placement for cancer therapy treatment.
timeFrame: through study completion, an average of 2 years
measure: Patient loss of speech increase or decrease
timeFrame: through study completion, an average of 2 years
measure: Patient loss of swallow function increase or decrease
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Patient knowledge of management and care of Gastrostomy Tube.
timeFrame: through study completion, an average of 2 years
measure: Maintaining swallowing function
timeFrame: through study completion, an average of 2 years
measure: Patient Reported Outcomes utilizing EORTC QLQ-C30 version 3 Questionnaire.
timeFrame: through study completion, an average of 2 years
measure: Patient Reported Outcomes utilizing EORTC QLO - H&N35 Questionnaire.
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
Study officials:
affiliation: St. John Health System
name: Candida Barlow, MSN RN
role: PRINCIPAL_INVESTIGATOR
References: