Clinical trial NCT03506451: PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
Official title: PaRTNer: Patient Reported Outcomes and Financial Toxicity in Head and Neck Cancer A Pilot, Survey Based Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Financial toxicity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: 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. Be able to read and write in English
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).

Primary outcomes:
measure: Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
timeFrame: 3 months post radiation therapy
measure: Financial toxicity, as measured by out of pocket (OOP) costs for a definitive course of treatment for HNC
timeFrame: 6 months post radiation therapy
measure: Financial toxicity, as measured by change in Comprehensive Score for financial Toxicity (COST)
timeFrame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
Secondary outcomes:
measure: Change in symptom burden, as measured by Functional Assessment of Cancer Therapy-Head and Neck (FACT-H&N) score
timeFrame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
measure: Change in quality of life, as measured by FACT-H&N score
timeFrame: Baseline, 3 months post radiation therapy, 6 months post radiation therapy
measure: Perceived quality of care
timeFrame: 3 months post radiation therapy, 6 months post radiation therapy
Other outcomes:
measure: Disease status
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Progression free survival
timeFrame: 5 years
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke University Health System (DUHS)
name: David Brizel Brizel, MD
role: PRINCIPAL_INVESTIGATOR
References: