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

Not Applicable

Withdrawn

• Conditions: Head and Neck Cancer
• Interventions: Other: Nurse Practitioner Clinic

• Registration Number: NCT02085525
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-03-10
• Study First Posted: 2014-03-13
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02
• Primary Completion: 2016-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weekly NP Visits	Nurse Practitioner Clinic	100 HNC (Head and Neck Cancer) patients seen weekly in a Nurse Practitioner (NP) led symptom management clinic for supportive care.
Every Other Week NP Visits	Nurse Practitioner Clinic	100 HNC (Head and Neck Cancer) patients seen every other week in a Nurse Practitioner (NP) led symptom management clinic for supportive care.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients that Experience a "Problem" during Cancer Treatment	11 weeks	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.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States