Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
NCT ID: NCT03416582
Last Updated: 2019-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2018-11-29
2019-08-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Raphael Yechieli
Associate Professor of Clinical Medicine
Principal Investigators
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Raphael Yechieli, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami Sylvester Cancer Center
Miami, Florida, United States
Countries
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Other Identifiers
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20180475
Identifier Type: -
Identifier Source: org_study_id
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