Head and Neck CancerPaRTNerNCT03506451
PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
A study testing Demographics questionnaires and the FACT HN questionnaire in people with Head and Neck Cancer, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Demographics questionnaires and the FACT HN questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2018to 13 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed description
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Demographics questionnaires and the FACT HN questionnaire
- Keywords
- Financial toxicity
- Medical subject headings
- Head and Neck Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Demographics questionnaires and the FACT HN questionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm non-therapeutic interventional study | Other | 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. Receives: Other: Demographics questionnaires and the FACT HN questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
Measured: 3 months post radiation therapy
Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
Measured: 6 months post radiation therapy
Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)
Financial toxicity will be measured using the comprehensive score for financial toxicity (COST). The range of the COST score is 0-44.
Measured: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary outcomes (3)
Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score
Measured: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Change in quality of life, as measured by FACT-H&N score
Measured: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Perceived quality of care
Patients will be asked to rate the quality of care as excellent, good, fair, poor, or very poor
Measured: 3 months post radiation therapy, 6 months post radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start19 Jun 2018
- Primary completion29 Nov 2021
- Study completion13 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pooja Karukonda, MD, Principal investigator, Duke University Health System (DUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506451
- Sponsor's protocol ID
- Pro00092590
- Acronym
- PaRTNer
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2018
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karukonda P, Chino F, Niedzwiecki D, Wan Z, Duffy E, Gaston J, Kaye D, Brizel DM, Mowery YM. Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer: A Nonrandomized Clinical Trial. JAMA Oncol. 2026 Sep 24:e263615. doi: 10.1001/jamaoncol.2026.3615. Online ahead of print.
PubMed 42783378