Weight Loss and Gastrostomy Tube Care Outcomes in Head and Neck Cancer Patients With Gastrostomy Tube Placement

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.

Conditions

• Malnutrition
• Gastrostomy

Interventions

OTHER

Nursing Education related to Gastrostomy Tube Care

The research nurse will provide educational intervention at each study visit utilizing the nursing process.

OTHER

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.

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

• St. John Health System, Oklahoma

  lead OTHER

Principal Investigators

• Candida Barlow, MSN RN · St. John Health System

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-07-31

Primary Completion

2018-12-31

Completion

2018-12-31

Countries

• United States

Study Locations