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

St. John Health System, Oklahoma

Status: Unknown

Conditions: Malnutrition; Gastrostomy

Treatments: Other: Nutritional Therapy Education and Evaluation; Other: Speech Therapy Education and Evaluation; Other: Nursing Education related to Gastrostomy Tube Care; Other: Quality of Life Questionnaire C30 version 3; Other: Quality of Life Questionnaire EORTC QLO - H&N35

Study type: Interventional

Funder types: Other

Identifiers

NCT02775721

G-Tube

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

Cohort A

Other group

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.

Treatment:

Other: Nursing Education related to Gastrostomy Tube Care

Other: Quality of Life Questionnaire C30 version 3

Other: Quality of Life Questionnaire EORTC QLO - H&N35

Other: Nutritional Therapy Education and Evaluation

Other: Speech Therapy Education and Evaluation

Cohort B

Other group

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.

Treatment:

Other: Nursing Education related to Gastrostomy Tube Care

Other: Quality of Life Questionnaire C30 version 3

Other: Quality of Life Questionnaire EORTC QLO - H&N35

Other: Nutritional Therapy Education and Evaluation

Other: Speech Therapy Education and Evaluation

Cohort C

Other group

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.

Treatment:

Other: Nursing Education related to Gastrostomy Tube Care

Other: Quality of Life Questionnaire C30 version 3

Other: Quality of Life Questionnaire EORTC QLO - H&N35

Other: Nutritional Therapy Education and Evaluation

Other: Speech Therapy Education and Evaluation