Sharon Davis

Evaluation of Factors Affecting Awareness of and Willingness to Participate in Cancer Clinical Trials

PURPOSE Annually, only 3% of patients participate in cancer clinical trials (CCTs). Barriers to accrual include lack of CCT awareness and uncertain third-party payer coverage. In January 2002, a California law (Senate Bill 37 [SB37]) required all third-party payers to reimburse patient care costs related to CCTs. We evaluated the level of awareness of patients and/or their family members/friends regarding CCTs and SB37. METHODS We used both a written survey for patients and/or their family members and friends seen in oncology clinics, and a verbal telephone version for Cancer Information Service callers. We tested for correlations between CCT awareness and SB37 knowledge, and willingness to participate in CCTs. RESULTS Of 1,188 respondents, 59% were aware of CCTs, 19% knew of SB37, and 36% were very likely to consider a CCT. There were significant positive correlations between CCT awareness and willingness to participate (P < .001, Spearman), and between SB37 knowledge and willingness to participate (P = .001, Pearson chi2). Reduced awareness was seen in respondents who were either black or African American (odds ratio [OR], 0.44; P = .004), Hispanic (OR, 0.56; P = .03), had an annual income less than 25,000 dollars (OR, 0.38; P < .001), or had less than a college degree (OR, 0.12 to 0.53; P < .001 to .013). Reduced willingness to participate in CCTs was seen in black or African American participants (OR, 0.38; P < .001), Asians (OR, 0.44; P < .006), or respondents aged 18 to 24 years (OR, 0.35; P = .002). CONCLUSION These results support the hypothesis that improving CCT awareness and SB37 knowledge especially among lower income, less educated, and minority patients, may potentially overcome barriers to participation and subsequently increase accrual in California.

Overcoming Barriers to Cancer Clinical Trial Accrual : Impact of a Mass Media Campaign

Annually, only 3% of adult patients participate in cancer clinical trials (CCT). Accrual barriers include lack of CCT awareness and uncertain third‐party coverage. In 2002, a California law (SB37) required all insurers to reimburse costs related to CCT. The objective of the current study was to increase awareness of CCT and SB37 through a mass multimedia campaign (MMC) in the University of California (UC) Davis (UCD) Cancer Center catchment area. The authors assessed willingness to participate in and accrual to CCT.

Asian Americans and cancer clinical trials: a mixed-methods approach to understanding awareness and experience.

Cancer clinical trials have been based on low accrual rates. Barriers to recruitment of minority populations affect the generalizability and impact of trial findings for those populations. The authors undertook a mixed‐methods approach to understanding levels of awareness and experiences with cancer clinical trials. A survey was administered to new cancer patients and their caretakers (family, close friends, or other social support) at outpatient oncology clinics. Field observations of the trial accrual process also were conducted by employing the grounded theory approach in qualitative methods. Comparison of survey results for Asian‐American respondents and non‐Asian respondents indicated that Asians were less likely to have heard the term “clinical trial” and were more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” than non‐Asians. Asians were more likely to have employer‐based insurance and to report understanding issues related to cost reimbursement. Asians were less likely to have been involved in or to know someone in a trial and reported less willingness than white respondents to consider trial participation. Qualitative observations suggested that Asians who presented for a potential trial were interested in the availability of a novel cancer therapy but were not eligible for available trials. Multiple strategies will be necessary to enhance awareness of and experience with accrual to cancer clinical trials for Asians, including richer understanding and increased involvement of Asians in cancer clinical trials and greater attention to the location and diversity of the Asian population in structuring study centers and evaluating trial results. Cancer 2005. Published 2005 by the American Cancer Society.

Adjuvant colon cancer care quality, risk, value, and level one data and guideline compliance among the elderly privately insured in southeastern USA.

249 Background: Oxaliplatin-containing regimens are among the most efficacious adjuvant treatments for locally-advanced colon cancer, although significant toxicity can occur. Because of relevant level I data, the NCCN revised its guidelines in 2012, recommending omission of oxaliplatin from combination adjuvant chemotherapy regimens for older patients (>70yo) with colon cancer. We examined prescribing behavior of oncologists between 2009 and 2014 to evaluate how rapidly NCCN guidelines were adopted into practice. METHODS This is a retrospective observational study of chemotherapy request data from more than 2,000 community oncologists in the southeastern United States. We examined 57 consecutive months of chemotherapy requests for stage II and III colon cancer patients 70 years and older, based on three epochs. During the middle epoch, one phase III trial evaluating oxaliplatin-containing regimens as adjuvant chemotherapy (NSABP C-07), and a revised 2012 NCCN guidelines, each supported omission of oxaliplatin from adjuvant chemotherapy regimens for older persons with colon cancer. Multivariate analyses evaluated associations among patient characteristics (age, gender, and performance status), disease stage, and time-period, with the odds of receiving oxaliplatin-containing regimens as adjuvant chemotherapy. RESULTS Among 266 persons with stage II or III colon cancer 70 years of age and older, over the six-year span, most adjuvant chemotherapy requests (184/266, 69.2%) contained oxaliplatin. Older age, male gender, and poor performance status were associated with significantly lower odds of receiving oxaliplatin-containing adjuvant chemotherapy regimens (p<0.05), while time period (epoch) was not significantly associated with temporal changes in patterns of use. CONCLUSIONS Use of oxaliplatin containing adjuvant chemotherapy regimens among older persons with colon cancer did not decrease following publication of phase III clinical trial data and revised NCCN guidelines recommending against oxaliplatin use in this setting. Focused quality improvement initiatives for this population of cancer patients may be helpful.

Quality and value implications of NCCN-compliant use of maintenance rituximab for patients with low-grade NHL.

36 Background: Rituximab maintenance for indolent, incurable non-Hodgkin lymphoma (NHL) remains controversial. NCCN supports maintenance rituximab for a span of up to two years as an alternative to watchful waiting following induction therapy. At least a dozen scientific papers have been published describing rituximab maintenance results; none has demonstrated overall survival benefit. The strongest data support comes from the PRIMA phase III trial which showed an increased PFS but no survival advantage. Increased toxicity, however, is clear and can be serious. Reports of progressive multifocal leukoencephalopathy, a rapidly fatal neurodegenerative disease, should be of especial concern to patients whose disease course can span many years. Oncology Analytics (OA) enhances cancer care quality and value by providing oncology decision-support to providers in SE USA. We hypothesized that the use of maintenance rituximab in this area of the country produces profound cost and real risk for a highly uncertain benefit to this population. METHODS We reviewed all requests for rituximab maintenance for low-grade NHL submitted by oncology practices to a major health insurer in one US region from Jul 2009-May 2014. We calculated the cumulative cost for blanket approval of such requests and the savings associated with our decision-support discussions of this questionable but NCCN-compliant practice. RESULTS 470 requests for maintenance rituximab for low-grade NHL were initiated within this 59-month span. The proportion of maintenance rituximab requests relative to the total chemotherapy requests decreased consistently over time, from 4.5% in the first six months of OA involvement in 2009, down to 1.5% in May 2014. The annual cost of rituximab maintenance, which depends on the dose schedule, ranges from about

Ensuring evidence-based cancer medicine by influencing prescribing behavior.

30,000 to

Understanding Asian American awareness of and experience with cancer clinical trials (CCTs): A mixed methods approach

40,000 per year. Additionally, we discovered many rituximab maintenance requests for durations exceeding two years without evidence-based support, most of which were rescinded after OA intervention. CONCLUSIONS Ongoing OA intervention reduces risk of toxicity and enhances the quality and value of cancer care for these patients.

Use, misuse, and overuse of white cell growth factors (GF) in community oncology practices in southeastern United States.

212 Background: Oncology Analytics, Inc. (OA) promotes evidence-based, guidelines-compliant cancer therapeutic decision-making on behalf of healthcare payers. The OA web-based 1,300 protocol treatment request system screens several hundred applications each month. Evidence-based requests are automatically approvable within seconds (Auto); those needing medical director (MD) review, within hours (Non-Auto). Some 10% of all requests require real-time consultation between OA board-certified medical oncologists/hematologists and the prescribing cancer specialist. Three-quarters of these non-compliant residual requests are rescinded by the treating oncologist. The remainder are either approved because of additional information while about 1% are recommended for an adverse determination. METHODS We hypothesize that OAs presence in a cancer market gradually improves the likelihood of evidence-based oncologist prescribing behavior. We tested this over 44 consecutive months of rapid growth, from May 2009 through December 2012, within a single southeastern US market. Since Auto requests are evidence- and guidelines-based, and Non-Auto requests are either not supported by evidence or have evidence support but with less toxic or less costly alternatives available, we reasoned that any sustained directional change in the ratio of Auto to Non-Auto represents a characteristic change in cancer specialist behavior over that span. The monthly ratios of Auto to Non-Auto were analyzed for trends by least squares and the slopes of each were contrasted by ANCOVA. RESULTS During the first six months, Auto-processed requests approximately equaled Non-Auto-processed request numbers, for a baseline ratio of one. Over the next 38 months, this ratio rose to approximately 1.4, meaning that 40% more requests were eventually approved automatically each month than those requiring MD review. The slopes of this relationship between Auto and Non-Auto approvals are statistically distinct (F = 43.34; p<0.001). CONCLUSIONS This progressive quality improvement reflects malleability of cancer doctor prescribing behavior, results in substantial savings, occurs quickly, persists and grows over time.

Annual rhythm in filgrastim use in southeast Florida.

6052 Background: Barriers to recruitment of minority populations affect generalizability, impact, and use of CCT findings for those populations. Methods: We undertook a mixed-methods approach to understand awareness of and experiences with CCTs. A self-administered survey using convenience sampling was provided in English to new cancer patients and their support persons at outpatient oncology clinics within a 9-county area of an NCI-designated cancer center. Observations of accrual processes to CCTs were conducted using the grounded theory approach. Results: 1006 surveys were completed and 59 unique patients observed. Comparison of survey results for Asian and non-Asian respondents showed Asians less likely to have heard the term “clinical trial” (59% Asian versus 69% all others) and more likely to define a clinical trial as “an experiment” or “a test procedure in a clinic” (n=45, 75%) than Whites (n=570, 61%) or persons of other ethnicities (n=107, 60%). Asians were more likely to have employer-based ins...