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

Study 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.

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedSymptom Management Education and Nurse Coaching and Drinks Diary

The study team can explain what participation involves.

Who it may be forLung Cancer · Mucositis Oral

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 13, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?University of Miami

Study sponsor

Study overview

What this study is about

Purpose: Supportive Care
Study type: Interventional
Phase: Not applicable
Sponsor: University of Miami
Interventions being studied: Behavioral: Symptom Management Education and Nurse Coaching; Behavioral: Drinks Diary

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Supportive or behavioral care→

Study topics

Survivorship and quality of life→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Miami Sylvester Cancer CenterMiami, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 13, 2019. Always confirm current availability with the study team.

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