Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration

NCT03416582 | Completed

• 1 other identifier: 20180475
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This is a descriptive mixed method pilot study to determine the feasibility of a tailored nurse-delivered telephone intervention designed to impact mucositis symptom severity and prevent dehydration in lung and head/neck cancer patients undergoing chemoradiation, therefore reducing overall symptom severity and improving quality of life. Secondary purposes for this study are to investigate if the nursing intervention can decrease lung and head/neck cancer patients' unscheduled medical visits between chemoradiation treatments.

Conditions

Lung Cancer; Mucositis Oral; Dehydration; Head and Neck Cancer

Outcome Measures

Primary Outcomes (3)

• Number of participants that completed calls

  Defined as the number of participants that completed 80% of the total 12 calls.

  6 weeks

• Duration of phone call

  Amount of time of the patient daily phone call (in minutes).

  6 weeks

• Percentage of patients using Intervention materials

  Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).

  6 weeks

Secondary Outcomes (9)

• Attrition Rate

  6 weeks

• Study Completion Rate

  6 weeks

• Participant Satisfaction

  6 weeks

• Change in severity of mucositis

  6 weeks

• Change in overall symptom severity

  10 weeks

Study Arms (1)

SMENC Group

EXPERIMENTAL

The Symptom Management Education and Nurse Coaching (SMENC) intervention is a one hour in-person face-to-face education session followed by twice weekly telephone calls conducted all throughout the patient's chemoradiation treatment regimen. During the telephone call, the patient will report the use of the Drinks Diary.

Behavioral: Symptom Management Education and Nurse Coaching; Behavioral: Drinks Diary

Interventions

Symptom Management Education and Nurse Coaching BEHAVIORAL

The registered nurse (RN) will teach good mouth care and management of sore mouth or throat (mucositis) symptoms to the patient for self-management at home. The RN will then call the patient twice every week to continue educating and coaching the patient about the mucositis self-management. The patient will receive the Symptom Management (SxM) Toolkit which is a written educational guide known as the "Cancer Treatment Symptom Management Education Toolkit" geared to help the patient manage their symptoms of sore mouth and throat at home in order to prevent dehydration.

SMENC Group

Drinks Diary BEHAVIORAL

The patient will complete the Drinks Diary daily by recording the all oral fluid ingested and also record the number of times the bathroom is used.

SMENC Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-Small Cell or Limited Stage Small Cell Lung Cancer OR Head \& Neck Cancer
• Over 18 years old
• Eligible for concurrent Chemoradiation in the first line setting
• Eastern Cooperative Group 0-2 (able to complete Activity of Daily Living (ADLs) independently or with assistive device only)
• Able to read \& write English or Spanish

You may not qualify if:

• Under 18 years old
• Underlying Anxiety or Depression (must pass screening tools)
• Medically Diagnosed with a Cognitive Impairment
• No prior Chemotherapy or Radiation treatment
• No access to a telephone
• Blind or Deaf or Illiterate
• Requires assistance with Self-Care ADLs

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Lung Neoplasms; Stomatitis; Dehydration; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Mouth Diseases; Stomatognathic Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Raphael Yechieli, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medicine

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: November 29, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Locations

US (1)