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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMENC Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that completed calls | Defined as the number of participants that completed 80% of the total 12 calls. | 6 weeks |
| Duration of phone call | Amount of time of the patient daily phone call (in minutes). | 6 weeks |
| Percentage of patients using Intervention materials | Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Attrition Rate | Attrition rate will be comprised of those study participants who drop out of the study and be computed as a percent. | 6 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raphael Yechieli, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Cancer Center | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D013280 | Stomatitis |
| D003681 | Dehydration |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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. |
|
| 6 weeks |
| Participant Satisfaction | Qualitative analysis of a customized Semi-Structured Interview | 6 weeks |
| 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. | 6 weeks |
| 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. | 10 weeks |
| 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. | 10 weeks |
| Unscheduled Medical Visits | Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration. | 6 weeks |
| 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. | 10 weeks |
| 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. | 10 weeks |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |