A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation

Study Overview
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Brief Summary
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A retrospective chart review of patients receiving concurrent chemoradiotherapy for oropharynx cancer was performed to compare clinical data for patients treated prior to the initiation of the NP clinic with those subsequently seen weekly in the NP clinic. The variables studied included; rate of hospitalization, dose completion and dose reductions. The results revealed an overall improvement in all variables for those patients seen in the weekly NP clinic. To further analyze this data a randomized, prospective study is proposed to validate the findings of the retrospective study. It is predicted that a weekly NP led clinic will decrease costly hospitalizations, increase patient treatment completion and improve overall patient quality of life and satisfaction.

Official Title
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A Randomized Comparative Study of a Weekly Versus Every Other Week Nurse Practitioner-led Symptom Management Clinic for Head and Neck Cancer Patients Undergoing Concurrent Chemotherapy and Radiation

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Nurse Practitioner Clinic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a diagnosis of stage III or IV HNC Are initiating concurrent chemotherapy and radiation Are able and willing to sign informed consent Ages 18 years or older ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (The ECOG score attempt to quantify cancer patients' general well-being and activities of daily life) Able to read and complete the required survey Exclusion Criteria: Cannot provided informed consent Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patient's ability to tolerate this treatment. Have a history of prior cancer within past 5 years (excluding non-melanoma skin cancer) Are unwilling or unable to complete the required QOL (Quality of Life) survey

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Weekly NP Visits<br>100 HNC (Head and Neck Cancer) patients seen weekly in a Nurse Practitioner (NP) led symptom management clinic for supportive care. | Other: Nurse Practitioner Clinic<br>* The nurse practitioner (NP) clinic is staffed by two NPs, one registered nurse, and several medical assistants. Patients can be seen by either NP during their treatment course. Patients will be scheduled to be seen in the (NP) clinic based on randomization assignment. Each clinic visit focuses on specific concerns and toxicities of the patient and their significant other. This will include physical as well as psychological, social and spiritual needs.<br>|
| Other: Every Other Week NP Visits<br>100 HNC (Head and Neck Cancer) patients seen every other week in a Nurse Practitioner (NP) led symptom management clinic for supportive care. | Other: Nurse Practitioner Clinic<br>* The nurse practitioner (NP) clinic is staffed by two NPs, one registered nurse, and several medical assistants. Patients can be seen by either NP during their treatment course. Patients will be scheduled to be seen in the (NP) clinic based on randomization assignment. Each clinic visit focuses on specific concerns and toxicities of the patient and their significant other. This will include physical as well as psychological, social and spiritual needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients that Experience a Problem during Cancer Treatment | A problem includes any one of three events: dose reduction, inability to complete treatment, or toxicity related hospitalization. Patients are assigned a 1 if any of these events occurs at least once during treatment or are assigned 0 if they complete treatment with no dose reductions or toxicity related hospitalizations. When data is analyzed and reported, the problem rate will be summarized along with the each individual negative component. | 11 weeks |