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

Not Applicable

Completed

• Conditions: Mucositis Oral; Head and Neck Cancer; Dehydration; Lung Cancer
• Interventions: Behavioral: Symptom Management Education and Nurse Coaching; Behavioral: Drinks Diary

• Registration Number: NCT03416582
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-11-29
• Primary Completion: 2019-08-22
• Study Completion: 2019-08-22
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SMENC Group	Symptom Management Education and Nurse Coaching	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.
SMENC Group	Drinks Diary	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.

Primary Outcome Measures

Name	Time	Method
Number of participants that completed calls	6 weeks	Defined as the number of participants that completed 80% of the total 12 calls.
Percentage of patients using Intervention materials	6 weeks	Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary).
Duration of phone call	6 weeks	Amount of time of the patient daily phone call (in minutes).

Secondary Outcome Measures

Name	Time	Method
Participant Satisfaction	6 weeks	Qualitative analysis of a customized Semi-Structured Interview
Attrition Rate	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	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.
Unscheduled Medical Visits	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	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.
Change in severity of mucositis	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.
Influence of Nurse-Delivered Telephone Intervention on Symptom Self-Management	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.
Change in overall symptom severity	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	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.

Trial Locations

Locations (1)

University of Miami Sylvester Cancer Center; 🇺🇸 Miami, Florida, United States