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

Primary Purpose

Lung Cancer, Mucositis Oral, Dehydration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Symptom Management Education and Nurse Coaching
Drinks Diary
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Sylvester Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SMENC Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of participants that completed calls
Defined as the number of participants that completed 80% of the total 12 calls.
Duration of phone call
Amount of time of the patient daily phone call (in minutes).
Percentage of patients using Intervention materials
Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).

Secondary Outcome Measures

Attrition Rate
Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.
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.
Participant Satisfaction
Qualitative analysis of a customized Semi-Structured Interview
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.
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.
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.
Unscheduled Medical Visits
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
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
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.

Full Information

First Posted
January 24, 2018
Last Updated
September 11, 2019
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT03416582
Brief Title
Feasibility Study of a Nurse Intervention to Impact Mucositis Severity and Prevent Dehydration
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 29, 2018 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Mucositis Oral, Dehydration, Head and Neck Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SMENC Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Symptom Management Education and Nurse Coaching
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Drinks Diary
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that completed calls
Description
Defined as the number of participants that completed 80% of the total 12 calls.
Time Frame
6 weeks
Title
Duration of phone call
Description
Amount of time of the patient daily phone call (in minutes).
Time Frame
6 weeks
Title
Percentage of patients using Intervention materials
Description
Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Attrition Rate
Description
Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent.
Time Frame
6 weeks
Title
Study Completion Rate
Description
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.
Time Frame
6 weeks
Title
Participant Satisfaction
Description
Qualitative analysis of a customized Semi-Structured Interview
Time Frame
6 weeks
Title
Change in severity of mucositis
Description
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.
Time Frame
6 weeks
Title
Change in overall symptom severity
Description
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.
Time Frame
10 weeks
Title
Change in quality of life
Description
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.
Time Frame
10 weeks
Title
Unscheduled Medical Visits
Description
Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.
Time Frame
6 weeks
Title
Influence of Nurse-Delivered Telephone Intervention on Self-Efficacy
Description
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.
Time Frame
10 weeks
Title
Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management
Description
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.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Yechieli, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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

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