Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
|ClinicalTrials.gov Identifier: NCT03416582|
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Mucositis Oral Dehydration Head and Neck Cancer||Behavioral: Symptom Management Education and Nurse Coaching Behavioral: Drinks Diary||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Actual Study Start Date :||November 29, 2018|
|Actual Primary Completion Date :||August 22, 2019|
|Actual Study Completion Date :||August 22, 2019|
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.
- Number of participants that completed calls [ Time Frame: 6 weeks ]Defined as the number of participants that completed 80% of the total 12 calls.
- Duration of phone call [ Time Frame: 6 weeks ]Amount of time of the patient daily phone call (in minutes).
- Percentage of patients using Intervention materials [ Time Frame: 6 weeks ]Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
- Attrition Rate [ Time Frame: 6 weeks ]Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.
- Study Completion Rate [ Time Frame: 6 weeks ]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.
- Participant Satisfaction [ Time Frame: 6 weeks ]Qualitative analysis of a customized Semi-Structured Interview
- Change in severity of mucositis [ Time Frame: 6 weeks ]
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.
- Change in overall symptom severity [ Time Frame: 10 weeks ]
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.
- Change in quality of life [ Time Frame: 10 weeks ]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.
- Unscheduled Medical Visits [ Time Frame: 6 weeks ]Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.
- Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy [ Time Frame: 10 weeks ]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.
- Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management [ Time Frame: 10 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416582
|United States, Florida|
|University of Miami Sylvester Cancer Center|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Raphael Yechieli, MD||University of Miami|