Study Stopped
Lack of funding.
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
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 10, 2014
CompletedFirst Posted
Study publicly available on registry
March 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedDecember 2, 2014
December 1, 2014
2 years
March 10, 2014
December 1, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Weekly NP Visits
OTHER100 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
OTHER100 HNC (Head and Neck Cancer) patients seen every other week in a Nurse Practitioner (NP) led symptom management clinic for supportive care.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francis Worden, M.D.
University of Michigan Rogel Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2014
First Posted
March 13, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Last Updated
December 2, 2014
Record last verified: 2014-12