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NCT Number: NCT03506451

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

About this study

This is a prospective, single institution, survey-based study to assess OOP costs, financial toxicity and pateint reported outcomes (PROs') (including QOL, quality of care, and attitudes/perspectives on the role of cost in treatment decisions). Potential participants are new patient consults in Radiation Oncology Head and Neck Cancer Clinic. Patients with an indication for definitive treatment involving radiation therapy will be approached by study staff and, if amenable, enrolled in the study. After signing informed consent, they will complete a baseline survey assessing socioeconomic household information, baseline symptoms/QOL and baseline costs/financial toxicity. They will be followed prospectively and re-surveyed at 3 and 6 months after completion of radiation therapy. Repeat assessments will document treatment costs and PRO including QOL, financial toxicity, and self-reported quality of care. Patients will be asked to collect all treatment-related bills in a provided binder, which will be reviewed at each survey date. Basic demographic data (including age, sex, race, marital status, zip code, and insurance coverage), comorbidities, smoking status, cancer characteristics (stage, site, histology), treatments received, emergency department visits and hospitalization rates at baseline, end of treatment, 3 months and 6 months after radiation treatment will be collected as part of this study. Disease status and survival will also be assessed from standard of care follow-up visits up to five years after completion of radiation treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult (18 years or older) patients
  • Diagnosed with HNC with treatment plan including definitive radiation therapy or chemotherapy/radiation therapy
  • Be able to read and write in English
  • Able to give informed consent and complete survey materials

Exclusion criteria

  • Recurrent disease
  • Metastatic disease
  • Prior radiation courses must be approved by PI prior to approaching patient for enrollment (prior systemic therapy is not an exclusion to study enrollment).

Treatment and study plan

Demographics questionnaires and the FACT HN questionnaire

Other

Patients will complete a baseline survey assessing socioeconomic household information, baseline symptoms, QOL, and financial toxicity, as well as attitudes toward cost conversations and educational handouts.

Primary outcomes

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

    Time frame: 3 months post radiation therapy

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

    Time frame: 6 months post radiation therapy

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

    Time frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy

    Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44.

Secondary outcomes

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

    Time frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy

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

    Time frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy

  3. Perceived quality of care

    Time frame: 3 months post radiation therapy, 6 months post radiation therapy

    Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor

Other outcomes

  1. Disease status

    Time frame: 5 years post completion of radiation treatment

  2. Overall survival

    Time frame: 5 years post completion of radiation treatment

  3. Progression free survival

    Time frame: 5 years post completion of radiation treatment

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: PaRTNer

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Apr 24, 2018
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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