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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03416582
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Raphael Yechieli, 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Number of participants that completed calls [ Time Frame: 6 weeks ]
    Defined as the number of participants that completed 80% of the total 12 calls.

  2. Duration of phone call [ Time Frame: 6 weeks ]
    Amount of time of the patient daily phone call (in minutes).

  3. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Participant Satisfaction [ Time Frame: 6 weeks ]
    Qualitative analysis of a customized Semi-Structured Interview

  4. 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.


  5. 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.


  6. 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.

  7. Unscheduled Medical Visits [ Time Frame: 6 weeks ]
    Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration.

  8. 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.

  9. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03416582


Locations
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United States, Florida
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Raphael Yechieli, MD University of Miami
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Responsible Party: Raphael Yechieli, Associate Professor of Clinical Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT03416582    
Other Study ID Numbers: 20180475
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Mucositis
Stomatitis
Dehydration
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes