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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

PaRTNer Trial 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.Check my eligibility

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.See study design

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.

PaRTNer Trial 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.

PaRTNer Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)

Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC

Secondary outcome measures

Change in quality of life, as measured by FACT-H&N score

Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score

Perceived quality of care

Other outcome measures

Disease status

Overall survival

Progression free survival

PaRTNer 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,009 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this research ongoing?

"This trial, which was initially posted on June 19th 2018 and last updated November 1st 2022 is no longer recruiting patients. However, 491 other medical studies are currently in search of volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study

2018. "PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03506451.

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