As a feasibility study to assess whether patients with locally advanced head and neck cancer would be willing to provide data regarding their finances, we approached patients within a clinical trial (Everolimus Versus Placebo in Head and Neck Cancer). Due to factors related to the therapeutic clinical trial (trial was on hold), patients were not enrolled from June to September 2012, which limited our ability to enroll patients in our study.

However, as we learned and developed methods and survey instruments to collect costs and data, including web data collection instruments, given our limitation in enrolling only patients within one clinical trial, we expanded our study to ALL patients with locally advanced head and neck cancer who are treated at the University of Chicago. The University of Chicago IRB approved this protocol amendment in December 2012 and we are about to start the expanded data collection. Data presented below is the results of our brief feasibility study within the protocol.

As part of the 10-069 protocol, eleven patients had complete cost data collected at three protocol time points (Baseline, Post-Induction, and Post-CRT).  At the baseline time point of this study, participants were asked to provide answers to 50 questions, (97 individual fields of information) regarding their income, home ownership, financial status, healthcare costs, and healthcare compliance, healthcare usage, and demographics. The question of whether participants would be willing to complete the form, and answer questions regarding personal finances and housing should be addressed in order to evaluate the feasibility of continuing data collection. Of the initial 11 participants who completed the baseline interview, all participants (100%) answered questions regarding their employment status, out-of-pocket costs, and insurance status. Moreover, all participants provided an estimate of their 2011 individual income (Range: $14,000 – 425,000) and their 2011 household income (Range: $35,500 – 440,000). In regards to answering questions about housing, 100% of participants provided household size (Range: 1 – 4 people). All participants provided data regarding home ownership: 9 (81.8%) participants owned, 1 (9.1%) participant rented, and 1 (9.1%) participant answered ‘Other.’  Of the participants who owned their residence, 90.9% reported an estimate of home value (Range: 130,000 – 1,000,000). All participants were able to complete the questionnaire during a visit to the University of Chicago Medical Center. No participants refused to provide financial information after having consented to participate.  Participants were asked to provide feedback about the questionnaire. No participants mentioned length of the questionnaire as too lengthy or difficult to complete. Likewise, no participants stated that the topics addressed in the questionnaire were inappropriate to query.

At the 2^nd and 3^rd data collection time points, data was collected for all eleven patients. The follow-up questionnaire consisted of 54 questions, regarding out-of-pocket costs, utilization of health services and financial burden and quality of life. Patients completed surveys at all time points, during clinic visits to the University of Chicago Medical Center. We collected data about patient’s cost of transportation (travel expenses, mode of travel, and distance from the medical center), with 77% of patients taking a private car to clinic. Parking cost patients an average of $4.80 per visit (Range: $0-$8). For patients who took alternate methods of transportation, the range of money spent on transportation per visit averaged $14.50 (Range: $2 – $27). Perhaps more significant is the 81.8% of patients were accompanied to clinic by a caregiver, typically their spouse (90%), whose loss of time or income, has not been estimated yet (Age of caregiver Range: 34 years – 64 years, Mean: 51.5; % Female = 90%). 40% of the caregivers endorsed taking time off from work to attend clinic visits, and 18.2% needed to secure childcare during these visits (Cost of childcare Range: $0 – $60; Mean: $20).

In regards to the impact of cost on quality of life, on 63.7% of the surveys patients reported that their cancer/treatment had reduced their satisfaction with their financial situation. Patients also reported a significant out-of-pocket expense between each time point. Mean out-of pocket costs per patient were $1,956 (Range: $0 – 6,000). Patients were asked to consider all out-of-pocket costs incurred by treatment-related expenses. A large portion of patient expenses were spent on medications (Range:  $0 – 700; Mean: $205.5). Patients did not report a substantial amount of cost incurred by specialist visits or homecare. However, for many patients utilizing insurance, the cost of care to date was still unknown, because they had not yet received medical bills. In terms of resource utilization, 45.5% of patients reported 1-3 visits to the emergency room, and 63.6% of patients had been admitted to the hospital since last interview. 72.7% of patient surveys reported utilizing at home healthcare or nursing aides (Range: 1 – 7 visits).

Funding

A research assistant was hired to attend clinics, interview patients, and collect their financial and quality of life data. As a trained clinical psychologist, this research assistant has been fundamental in developing surveys and approaching patients.

Expansion Plans

Currently, we have two CTRC/IRB approved protocols to prospectively collect cost data from patients with locally advanced head and neck cancers over the course of their treatment, and to improve an instrument to measure patient’s experience of financial burden and its impact on quality of life.

Summary of Project Expansion

This project focuses on prospectively assessing the incurred costs of head and neck cancer patients. The primary objectives are to fully describe the direct medical costs, indirect costs and cost-of-illness from a societal perspective in head and neck cancer, as well as the out-of-pocket costs incurred by patients. Additionally, a comparison of two data collection methods (a paper-based cost collection and a web-based method) will be performed. Secondary objectives are to prospectively determine changes in work status and household income in patients with head and neck cancer and to identify patient subgroups that are at a higher risk of experiencing financial burden. Expected patient outcomes of this research include understanding and identifying the financial impact and burden of disease incurred by patients aggressively treated for a curable malignancy. Additionally, we plan to develop and validate a method that enables patients to enter their own data, including out-of-pocket costs, via the web.

Project: Measuring Financial Burden in Locally Advanced Head and Neck Cancer Running Title: The Development of the Chicago Assessment of Social Health Outcomes (CASH) Database Objectives • To develop a comprehensive database to facilitate assessment of potentially modifiable social and financial variables for patients with locally advanced head and neck cancer (LAHNC). Brief Background: • Locally advanced squamous cell carcinoma of the head and neck (LAHNC) is a potentially curable disease. Yet, its multimodality treatment carries significant morbidity, including not only physical, but also social and financial issues. Therefore, we are prospectively assessing this selected group of patients for potentially modifiable social factors. Brief Methods: • Patients with LAHNC at an academic medical center (University of Chicago) • Longitudinal survey data assessing: o Out-of-pocket costs o Loss of productivity o Healthcare utilization o Potentially modifiable social factors o Loneliness o Social support o Healthcare utilization variables included emergency room encounters, hospital admissions, out-of-pocket costs, and scheduled outpatient visits. o Financial toxicity was measured by use of personal savings and credit card loans. o Social demographic variables included age, gender, education, race, and income. o Patients are assessed with monthly surveys from the start of the treatment. o Spearman¹s correlation coefficients were used to assess the strength of relationships. • Total number of enrolled patients: 65, followed over 18 months. Results (Patients are still being followed within the database) • We report the preliminary results of 50 patients followed for 3 months from start of treatment. • Higher out-of-pocket costs were associated with: o Lower level of healthcare utilization (as measured by the following variables): o Fewer return patient visits (r = -0.32, p < 0.05) o Fewer emergency room encounters (r = -0.32, p < 0.05) o Higher levels of financial toxicity (as measured by the following variables): o Use of personal savings to pay for cancer care (r = 0.34, p < 0.05) o Borrowing from credit cards to pay for cancer care (r = 0.38, p < 0.001). • Baseline assessments of loneliness and social support were associated with increased likelihood of “no show” for clinical encounters (r = 0.31, p < 0.05). • The “no show” variable was associated with missing prescription medications (r = 0.32, p < 0.05). Changes in Care Delivery Resulting from Research: • Loneliness and Social Support Scale to be used for social workers in pilot programs to screen patients who may need a cancer navigator. • Increasing awareness of patient’s financial toxicity. Budget: • Funds used to hire a research assistant to go to clinics and interview patients. • Two tablets for data collection. • Mailing survey to patients. • Presented at a Head and Neck Surgery Meeting in the Winter of 2015. Investigator Gains • Jonas de Souza been recognized as one of the pioneers of the concept of patient’s financial burden (or toxicity) Plans: • Continue follow-up of 65 patients over 18 months. • Extend the period of follow-up to further clarify the strength of our initial data. • Develop specific interventions to modify these social variables and improve outcomes for these patients. • Developing the website www.costofcancercare.org with the University of Chicago. Release during ASCO (June 2015). • Submit the paper by end of 2015. • Preliminary data for a K-grant to be submitted in October 2015.