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

University of Michigan Rogel Cancer Center

Status: Withdrawn

Conditions: Head and Neck Cancer

Treatments: Other: Nurse Practitioner Clinic

Study type: Interventional

Funder types: Other

Identifiers

NCT02085525

HUM00085186 (Other Identifier)

UMCC 2014.018

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Weekly NP Visits

Other group

Description:

100 HNC (Head and Neck Cancer) patients seen weekly in a Nurse Practitioner (NP) led symptom management clinic for supportive care.

Treatment:

Other: Nurse Practitioner Clinic

Every Other Week NP Visits

Other group

Description:

100 HNC (Head and Neck Cancer) patients seen every other week in a Nurse Practitioner (NP) led symptom management clinic for supportive care.

Treatment:

Other: Nurse Practitioner Clinic