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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the financial burden of cancer treatment for people with head and neck cancer undergoing radiation therapy, possibly combined with chemotherapy or surgery. Researchers seek to determine how these costs affect patients' quality of life and treatment decisions. Participants will complete several questionnaires, including demographics questionnaires and the FACT HN questionnaire, over time to share their experiences. This trial may suit adults who have head and neck cancer, are set to start radiation therapy, and can read and write in English. As an unphased trial, this study offers participants the chance to provide valuable insights into the financial challenges of cancer treatment, potentially improving future care.

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.

What prior data suggests that these questionnaires are safe for participants?

This study does not test a new treatment. Instead, it examines the costs associated with receiving treatment for head and neck cancer. Participants will complete surveys about their finances and quality of life. Since no new drugs or procedures are being tested, there are no safety concerns. The focus is on understanding how paying for cancer treatment impacts patients' lives.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover the impact of financial toxicity on patients with head and neck cancer. Unlike typical treatment options that focus solely on physical symptoms, this study uses detailed questionnaires to explore the financial burden patients experience during and after treatment. By understanding these financial challenges, the trial could lead to more comprehensive care strategies that address both medical and economic aspects of patient well-being.

What evidence suggests that this study's questionnaires are effective for assessing financial toxicity in head and neck cancer patients?

This study does not test a new treatment for head and neck cancer and will not provide information about treatment efficacy. Instead, it focuses on understanding the financial strain, or "financial toxicity," of cancer care. Through questionnaires, the study examines how treatment costs affect patients' lives and their treatment decisions. It aims to gather information on how paying for treatment impacts patients' quality of life. This can help doctors and researchers understand the financial challenges patients face during cancer treatment.

Who Is on the Research Team?

Pooja Karukonda, MD

Principal Investigator

Duke University Health System (DUHS)

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations