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Completed

NCT Number: NCT03416582

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

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 information

Conditions

Lung Cancer Dehydration Head and Neck Cancer Head and Neck Neoplasms Lung Diseases Lung Neoplasms Metabolic Diseases Mouth Diseases Mucositis Oral Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomatitis Stomatognathic Diseases Thoracic Neoplasms Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symptom Management Education and Nurse Coaching

Behavioral

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

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 31, 2018
Registry last updated
Sep 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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