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Survey Study on Financial Toxicity for Head and Neck Cancer (PaRTNer Trial)

N/A
Waitlist Available
Led By David Brizel Brizel, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy
Be older than 18 years old
Must not have
Metastatic disease
Recurrent disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post radiation therapy, 6 months post radiation therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial is exploring the financial toxicity of cancer care for patients during definitive treatment of head and neck cancer.

Who is the study for?
This study is for adult patients with head and neck cancer (HNC) who are set to undergo radiation therapy, with or without chemotherapy, or surgical resection. Participants must be able to read and write in English and provide informed consent. Those with metastatic disease, recurrent disease, or previous radiation treatments not approved by the principal investigator cannot join.
What is being tested?
The PaRTNer study is examining the financial burden of HNC treatment on patients. It uses questionnaires to measure out-of-pocket costs and how these expenses affect quality of life and decisions about treatment from the patient's viewpoint during definitive cancer care.
What are the potential side effects?
Since this trial involves completing surveys rather than testing a medical intervention, there are no direct physical side effects associated with participating in this research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have head or neck cancer and will undergo radiation or chemo with radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer has spread to other parts of my body.
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My condition has come back after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post radiation therapy, 6 months post radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post radiation therapy, 6 months post radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)
Secondary study objectives
Perceived quality of care

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single arm non-therapeutic interventional studyExperimental Treatment1 Intervention
All subjects who enroll on study will be asked to complete questionnaires at baseline before treatment starts; the questionnaires are repeated at one month, three and six months after radiation therapy has been completed. the demographics questionnaire is completed at baseline only; the FACT-HN is completed at all four time points.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,389 Total Patients Enrolled
David Brizel Brizel, MDPrincipal InvestigatorDuke University Health System (DUHS)
Yvonne Mowery, MD PhDPrincipal InvestigatorDuke University Health System (DUHS)
1 Previous Clinical Trials
120 Total Patients Enrolled

Media Library

Single arm non-therapeutic interventional study Clinical Trial Eligibility Overview. Trial Name: NCT03506451 — N/A
Head and Neck Cancers Research Study Groups: Single arm non-therapeutic interventional study
Head and Neck Cancers Clinical Trial 2023: Single arm non-therapeutic interventional study Highlights & Side Effects. Trial Name: NCT03506451 — N/A
Single arm non-therapeutic interventional study 2023 Treatment Timeline for Medical Study. Trial Name: NCT03506451 — N/A
~8 spots leftby Dec 2025