Duke Cancer Center
Durham, North Carolina, 27710, United States
NCT Number: NCT03506451
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27710, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months post radiation therapy
Time frame: 6 months post radiation therapy
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.
Time frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Time frame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
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
Time frame: 5 years post completion of radiation treatment
Time frame: 5 years post completion of radiation treatment
Time frame: 5 years post completion of radiation treatment
Duke University
Other
Acronym: PaRTNer
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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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