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

Feasibility Study of a Nurse-Delivered Telephone Intervention To Impact Mucositis Symptom Severity and Prevent Dehydration in Lung and Head/Neck Cancer Patients Undergoing Chemoradiation: A Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Lung Cancer; Dehydration; Mucositis Oral
• Intervention / Treatment: Behavioral: Symptom Management Education and Nurse Coaching; Behavioral: Drinks Diary

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Sylvester Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SMENC Group; 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; 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.; Behavioral: Drinks Diary; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attrition Rate	Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.	6 weeks
Study Completion Rate	Length of time spent in the study will be expressed as a percent and it is expected that the participants will complete 75% of their planned chemoradiation treatments.	6 weeks
Participant Satisfaction	Qualitative analysis of a customized Semi-Structured Interview	6 weeks
Change in severity of mucositis	Mucositis severity will be measured daily by the Oral Mucositis Daily Questionnaire (OMDQ). A score of 0 equals no mucositis severity and high mucositis severity equals a score of 4 on question 2.	6 weeks
Change in overall symptom severity	The M.D. Anderson Symptom Inventory - Lung Cancer / Head & Neck Cancer(MDASI-LC; MDASI-HN) will be used to measure overall severity. The total MDASI-LC; HN score will be used in the analysis of overall symptom severity. Friedman's test is the test statistic that will be used to measure the effect of the intervention on overall symptom severity per cycle of chemoradiation treatment.	10 weeks
Change in quality of life	Health Related Quality of Life (HRQoL) will be measured by the Functional Assessment of Cancer Therapy - Lung and Head & Neck versions (FACT-L; FACT-H&N respectively ). The FACT-L & FACT H&N are both a five domain, 36 item self-report instrument scored on a 5 point Likert scale (zero to 4) with a score range of 0-144; the higher the score = higher HRQoL.	10 weeks
Unscheduled Medical Visits	Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.	6 weeks
Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy	The adapted Chronic Disease Self-Efficacy Scale (CDSES) was developed by combining the subscales of Manage Disease in General Scale and the Symptoms Scale for a combined 10 item scale to measure the concept of perceived self-efficacy. Each item is scored 0 to 8; with the higher combined sum score equating to a higher perceived self-efficacy in the participant.	10 weeks
Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management	The Partners in Health Scale (PIHS) was designed to measure adherence to treatment, knowledge of disease, management of side effects and management of signs and symptoms over time. The 12 item questionnaire scores each question among the domain categories on a 9 point scale from 0-8 and the higher sum score reflects a higher self-management in the participant.	10 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Raphael Yechieli, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2018
• Primary Completion (Actual): August 22, 2019
• Study Completion (Actual): August 22, 2019

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 24, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2019
• Last Update Submitted That Met QC Criteria: September 11, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Water-Electrolyte Imbalance; Head and Neck Neoplasms; Mucositis; Dehydration; Stomatitis
• Other Study ID Numbers: 20180475

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No