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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

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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:

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My cancer has spread to other parts of my body.

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My condition has come back after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post radiation therapy, 6 months post radiation therapy

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.

0 / 3Eligibility criteria met