Survey Study on Financial Toxicity for Head and Neck Cancer

(PaRTNer Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Recurrent, Metastatic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

60 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems focused on financial aspects rather than treatment changes, so you likely won't need to stop them.

Is the financial toxicity survey study safe for participants?

The survey study involves answering questions about financial stress and quality of life, which is generally safe for participants. There are no physical risks involved in completing questionnaires like the Demographics and FACT HN. ^{1 2 3 4 5}

How does this treatment for head and neck cancer differ from other treatments?

This study focuses on the financial impact of head and neck cancer treatments, which is a unique aspect compared to other studies that typically focus on medical outcomes. It highlights the financial burden patients face, which can affect their quality of life and survival, making it an important consideration in treatment planning. ^{1 2 6 7 8}

What is the purpose of this trial?

The purpose of this single institution, pilot study is to explore the out of pocket (OOP)costs and financial toxicity of cancer care for patients during definitive treatment of head and neck cancer with radiation therapy with or without chemotherapy and surgical resection. The study team will assess how the financial burden of cancer care impacts quality of life as well as treatment-related decision-making from a patient perspective.

Research Team

David Brizel Brizel, MD

Principal Investigator

Duke University Health System (DUHS)

Eligibility Criteria

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.

Inclusion Criteria

Be able to read and write in English

Able to give informed consent and complete survey materials

I have head or neck cancer and will undergo radiation or chemo with radiation.

Exclusion Criteria

My cancer has spread to other parts of my body.

My previous radiation treatments must be approved by the study leader before I can join.

My condition has come back after treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete a baseline survey assessing socioeconomic household information, baseline symptoms/QOL, and baseline costs/financial toxicity

1 week

1 visit (in-person)

Treatment

Participants undergo definitive treatment involving radiation therapy, with or without chemotherapy and surgical resection

6-8 weeks

Follow-up

Participants are re-surveyed at 3 and 6 months after completion of radiation therapy to assess treatment costs, PROs including QOL, financial toxicity, and self-reported quality of care

6 months

2 visits (in-person)

Long-term Follow-up

Disease status and survival are assessed from standard of care follow-up visits up to five years after completion of radiation treatment

5 years

Treatment Details

Interventions

• Demographics questionnaires and the FACT HN questionnaire

Trial Overview 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.

Participant Groups

Group I: Single arm non-therapeutic interventional study Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Association of significant financial burden with survival for head and neck cancer patients treated with radiation therapy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Association of self-reported financial burden with quality of life and oncologic outcomes in head and neck cancer. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Longitudinal oncology registry of head and neck carcinoma (LORHAN): initial supportive care findings. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Patient-reported financial toxicity and adverse medical consequences in head and neck cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Financial Toxicity in Head and Neck Cancer Patients Treated With Proton Therapy. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Assessment of self-reported financial toxicity among patients with nasopharyngeal carcinoma undergoing radiotherapy: A cross-sectional study in western China. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Understanding financial toxicity in head and neck cancer survivors. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Measuring financial toxicity incurred after treatment of head and neck cancer: Development and validation of the Financial Index of Toxicity questionnaire. [2021]