PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
| Status: | Recruiting |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | June 19, 2018 |
| End Date: | June 2025 |
| Contact: | Bijal Shah, MS |
| Email: | shah@neuro.duke.edu |
| Phone: | 919 6683726 |
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.
(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.
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.
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.
Inclusion Criteria:
1. Adult (18 years or older) patients
2. Diagnosed with HNC with treatment plan including definitive radiation therapy or
chemotherapy/radiation therapy
3. English-speaking
4. Able to give informed consent and complete survey materials
Exclusion Criteria:
1. Recurrent disease
2. Metastatic disease
3. Prior radiation courses must be approved by PI prior to approaching patient for
enrollment (prior systemic therapy is not an exclusion to study enrollment).
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