Dehydration, Head and Neck Cancer, Lung Cancer, Mucositis Oral
Conditions
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.
Interventions
BEHAVIORALSymptom 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.
BEHAVIORALDrinks 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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that completed calls | 6 weeks | Defined as the number of participants that completed 80% of the total 12 calls. |
| Duration of phone call | 6 weeks | Amount of time of the patient daily phone call (in minutes). |
| Percentage of patients using Intervention materials | 6 weeks | Percentage of the patients who reports using the interventions materials (SxM Toolkit and Drinks Diary). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Unscheduled Medical Visits | 6 weeks | Number of unplanned medical visits made by the patient to the Oncologist for intravenous fluid administration. |
| 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. |
| Participant Satisfaction | 6 weeks | Qualitative analysis of a customized Semi-Structured Interview |
Countries
United States
Outcome results
None listed