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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03416582
• Other study ID #: 20180475
• Status: Completed
• Phase: N/A
• Start date: November 29, 2018
• Est. completion date: August 22, 2019

Study information

• Verified date: September 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 22, 2019
• Est. primary completion date: August 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Head and Neck Cancer
• Head and Neck Neoplasms
• Lung Cancer
• Mucositis
• Mucositis Oral

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Miami Sylvester Cancer Center	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants that completed calls	Defined as the number of participants that completed 80% of the total 12 calls.	6 weeks
Primary	Duration of phone call	Amount of time of the patient daily phone call (in minutes).	6 weeks
Primary	Percentage of patients using Intervention materials	Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).	6 weeks
Secondary	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
Secondary	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
Secondary	Participant Satisfaction	Qualitative analysis of a customized Semi-Structured Interview	6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Unscheduled Medical Visits	Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.	6 weeks
Secondary	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
Secondary	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