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
NCT ID: NCT02085525
Last Updated: 2014-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2014-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Weekly NP Visits
100 HNC (Head and Neck Cancer) patients seen weekly in a Nurse Practitioner (NP) led symptom management clinic for supportive care.
Nurse Practitioner Clinic
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.
Every Other Week NP Visits
100 HNC (Head and Neck Cancer) patients seen every other week in a Nurse Practitioner (NP) led symptom management clinic for supportive care.
Nurse Practitioner Clinic
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.
Interventions
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Nurse Practitioner Clinic
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Francis Worden, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Rogel Cancer Center
Locations
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University of Michigan Hospital
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00085186
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2014.018
Identifier Type: -
Identifier Source: org_study_id