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

December 1, 2014 updated by: University of Michigan Rogel Cancer Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Weekly NP Visits
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

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.
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Patients that Experience a "Problem" during Cancer Treatment
Time Frame: 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.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan Rogel Cancer Center

Investigators

  • Principal Investigator: Francis Worden, M.D., University of Michigan Rogel Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

March 10, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMCC 2014.018
  • HUM00085186 (Other Identifier: University of Michigan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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