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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
- ClinicalTrials.gov ID
- NCT03506451
- Acronym / sponsor ID
- PaRTNer / Pro00092590
- Conditions
- Head and Neck Cancer
- Keywords
- Financial toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 13 Apr 2026 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm non-therapeutic interventional study | Other | Other: Demographics questionnaires and the FACT HN questionnaireAll 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Demographics questionnaires and the FACT HN questionnairePatients 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. | Other | Single arm non-therapeutic interventional study |
Primary outcome
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
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
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.
3 secondary outcomes
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
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
Perceived quality of care
Time frame: 3 months post radiation therapy, 6 months post radiation therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Results publication: PubMed 42783378Karukonda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pooja Karukonda, MD principal investigator
Duke University Health System (DUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03506451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.