ENACCT's Blog

March 26th, 2010

For the past three years, the Franciscan Health System Cancer Center Community Cancer Program was involved locally with the Tacoma-Pierce County Health Department as part of the ENACCT Pilot Education Program (PEP), a LIVESTRONG funded grant to promote cancer clinical trials enrollment in medically underserved communities. The Franciscan Health System Cancer Center is part of the Cross-Cultural Collaborative; a group representing over 30 local agencies committed to health equity issues in our community. The Cross-Cultural Collaborative has representatives from 6 distinct communities representing groups often affected by health disparities. The six groups of participants are: African American groups, Asian Pacific Islander groups, Native American groups, Spanish-speaking groups, Lesbian/Gay/Transgender/Queer groups and low-income representatives. This is unique to Pierce County and as far as we are aware, this type of collaboration exists no where else in the United States. Several hundred local community leaders and community members were trained in the value of cancer clinical trials and Franciscan Health System had several employees (primarily RN's) who participated in training and then received certification to train other health care providers in the value of cancer clinical trials.

During the course of PEP, national ENACCT staff noted the work that Queens Hospital in New York has been doing in recruiting and retaining medically underserved, non-English speaking patients into cancer clinical trials. During a recent visit to New York, I had the pleasure of talking with Linda Bulone, OCN, CCRC, Director of the Cancer Research Center at Queens Hospital Cancer Center, about her role in the development of this program and what lessons we could learn for minority enrollment in cancer clinical trials here in Pierce County.

Queens Hospital is a publicly funded institution and the bulk of the patient population is low-income or uninsured, composed largely of immigrants; over 108 languages are spoken in the hospital. Queens Hospital hired Linda to develop a cancer clinical trials program 5 years ago. At the time of her arrival, she found the hospital faced barriers to enrolling patients in cancer clinical trials, as oncologists were often seeing a high volume of patients in a short period of time, and lacked sufficient time and resources to recruit patients. Since then, the program has worked on making the enrollment process easier for doctors by consenting patients and spending time with patients to discuss trials prior to enrollment. Currently, Queens Hospital enrolls 85 to 90 non-English speaking cancer patients into treatment trials annually, from a total annual cancer patient population of 500 newly diagnosed cases - almost 25% of the total new cases seen there each year.

One of the goals of their cancer clinical trials program is to assure that hospital has at least one trial open for cancers commonly experienced in their patient population. Additionally, by speaking frequently with providers to remind them about potential protocols and regularly attending tumor boards, trust has been developed with the physicians. They now refer patients automatically, and every single new patient is sent to see the research nurse. In cases where there are language barriers, a Language Line is used. The National Cancer Institute (NCI) does not cover the cost of translating consent forms, so when necessary, Queens Hospital will pay for this through a local certified translation company. Additionally, Linda indicated that the Director of the oncology program at Queens Hospital has developed a special fund to pay for NCI consent form translations using honorarium fees and other donations. Interestingly, while Queens Hospital is not allowed to use short form consent for a cancer clinical trial at their hospital, Franciscan Health System has been approved to use a short form consent, approved by the local IRB through the ENACCT grant efforts in our community. Franciscan Health System's ability to use the short form locally reduces the cost of translation for NCI grants considerably.

Ultimately, despite the time and effort involved in engaging patients and providers, Linda believes it is worthwhile. Benefits include increased trial compliance, trust and enhanced communication. This is a win-win situation for patients and the Cancer Center at Queens Hospital. They have succeeded in removing or overcoming many of common barriers and belief systems that keep researchers from enrolling non-English speaking patients into cancer clinical trials, and are poised for continued success. I was pleased to have the opportunity to learn about their accomplishments, and I am certain their story will encourage other institutions across the country to do the same.

(For information on Language Line Services: http://www.languageline.com/)

Special thanks to Tricia Sinek RD, CD and Linda Bulone RN as contributors for this posting

January 26th, 2010

A Washington Post op-ed by Georgetown University's John L. Marshall, MD, and a letter published in response, outline just some of the difficulties in making progress against cancer-not least of which is persuading adult cancer patients to take part in clinical trials.

In a 2009 Research!America poll of the general public, 30 percent of Americans say that they would be very likely to participate in a clinical trial, yet just six percent say their doctor has ever suggested it. Willingness in concept and actual participation may be vastly different things, but for cancer patients, whose incentive to participate in clinical research should be strong, the numbers are disconcertingly low. Although 20 percent of all cancer patients are eligible, fewer than five percent take part in cancer clinical trials-and the numbers are even lower among minorities and medically underserved populations. ^{1, 2, 3, 4} Nearly 40 percent of National Cancer Institute cooperative group trials close early.⁵

As Dr. Marshall wrote in the Post, "Our understanding of cancer therapies comes from the five percent of patients who enroll in trials, a tiny database when we consider the highly variable nature of the disease." Given this, our slow rate of progress against cancer may be less surprising, but frustration with that pace should be a wake-up call.

Proven solutions do exist. Trial participation can be enhanced through community-driven education and advocacy efforts, by helping to change attitudes and behaviors of providers and patients. ENACCT is the only national organization solely focused on identifying community-centered approaches to cancer clinical trials education. ENACCT's well-regarded training programs have helped community leaders, primary care providers and cancer research staff break down some of the complex barriers to getting more patients involved in research. Implementing such programs on a broader scale is a crucial step to making greater strides against all types of cancer and particularly in reducing the disproportionate impact on some of the most vulnerable Americans.

Special thanks to ENACCT Board Member Heather Jameson of Research!America for her work on this posting

October 8th, 2009

In a recent NCI commentary, (http://www.cancer.gov/ncicancerbulletin/090809/page4) the Associate Director of the NCI's Division of Cancer Control and Population Sciences outlined the critical role that primary care providers can and should play in helping their patients with cancer.

Dr. Rachel Ballard-Barbash noted that as the array of cancer treatment options becomes increasingly complex, we need to be able to count on primary care providers who can play a role in the appropriate coordination and delivery of care. In fact, as her commentary noted, a recent NCI study indicated that some primary care providers are already actively engaged in coordination of their patients' cancer care and management of co-morbid conditions.

At ENACCT, we share the concerns of Dr. Ballard-Barbash-and in addition, believe that primary care providers have an important role in helping facilitate patient understanding of broad treatment options, including clinical trials, as they make their first referrals to the local oncologist. Yet, only 2% of primary care providers routinely discuss cancer trials with their patients; thirty-seven percent lack awareness of local trials for patients (Crosson J Cancer Educ, 2001).

If we are to make further advances and help patients to fully benefit from the growing ranges of treatment options that continue to be discovered, we believe that all primary care providers must be committed to sharing information about cancer clinical trials. Recognizing the different time/resource commitments that exist, ENACCT's training programs propose provider engagement along a continuum, from "low intensity" involvement through placement of patient education materials in office waiting rooms to higher levels of involvement through basic discussions of cancer clinical trials with patients to referrals to trial-participating oncologists.

It is imperative that we promote greater primary care provider education about cancer clinical trials; however, ENACCT has been challenged in promoting this goal. Some providers feel it is not their responsibility to discuss treatment options, and prefer to leave that discussion to the oncologist. Others simply lack knowledge or awareness about clinical trials, or share common myths about their appropriateness for all cancer stages. A 2004 article by Sherwood et. al ('To Refer or Not to Refer: Factors that Affect Primary Care Provider Referral of Patients with Cancer to Clinical Treatment Trials', Journal of Cancer Education, 19:1, 58 - 65) confirmed the importance of educating primary care providers about cancer clinical trials; the more training they had the more likely they were to make a patient referral to providers conducting clinical trials.

ENACCT is pleased to offer an introductory online workshop "Your Role in Cancer Clinical Trials: Why They Are Important for My Practice" to help address this important need. A free one-hour course, offering free continuing education credits for physicians, nurses and social workers, the course focuses on prompting primary care provider action on referral to local oncologists who participate in clinical trials; educating patients about the importance of clinical trials as an option for first line treatment; and encouraging patients to ask about clinical trials when meeting with oncologists. To learn more about the course for primary care providers and how to register, please visit www.enacct.org/yourrole.

September 21, 2009

Authors of a recent article published in the Journal of Clinical Oncology (Breslin TM, Morris AM, et al. Hospital factors and racial disparities in mortality after surgery for breast and colon cancer; JCO, Vol. 27, No. 24, pp. 3945-3950) offer up a thought-provoking rationale for why some disparities in cancer survival may exist among different groups of patients. Using SEER, the authors analyzed data from over 25,000 breast cancer patients and over 22,000 colon cancer patients across 436 hospitals. Their analysis revealed that patients, regardless of race, who received treatment in facilities serving predominantly black patients, experienced a 32 % higher mortality risk after five years for breast cancer and a 27% higher mortality risk after five years for colon cancer.

The authors suggest there may be certain factors at play in the facilities serving mostly Black patients that somehow translates into poorer survival rates for all patients of these hospitals. They speculate that it could be the result of poorly delivered or limited care. Such a conclusion would support previous findings in the literature which note that minorities and the poor are often more likely to receive no treatment, or treatment that does not meet current standards of care. The 1999 Institute of Medicine report, Unequal Treatment, also points out how lack of equal treatment may lead to disparate outcomes. While no single institutional factor was blamed in the study as the culprit, clearly there are a number of system factors that can either help or hinder the delivery of quality cancer care to all patients. One area that is not explored is whether the facilities serving predominantly black patients provide access to cancer clinical trials to these patients.

The availability of, and access to, cancer clinical trials is regarded as an established standard for the provision of quality comprehensive cancer care according to the American College of Surgeons' Commission on Cancer (ACOSCOC). In fact, some studies have suggested that research participation may be associated with improved clinical outcomes; leading some researchers to recommend trial participation as a means to better treatment. Yet, we are still faced with a simple fact: racial/ethnic minorities with cancer are less likely to be offered the option to participate in a clinical trial. And if they are coming to a health care site that doesn't participate in clinical trials at all, whether due to lack of institutional capacity or other factors, the opportunity to access clinical trials may be completely closed off.

We must find ways to address this disparity. One potential approach is to encourage partnerships between institutions that offer cancer clinical trials and those that do not so that the treatment access pathway experienced by patients is not limited. Such an approach can be mutually beneficial- first, for non trial-participating organizations, as it offers an additional resource for their patients, as well as for the institutions offering trials, who very often experience low rates of minority participation.

ENACCT, using a multipronged approach of working with communities, health care providers and cancer research teams, also works to enhance trial access by educating community members to advocate for themselves in asking their doctor about cancer research studies; encouraging providers to refer patients to sites offering clinical trials; and training cancer clinical trial teams to improve their recruitment strategies and infrastructure to improve participation rates among minorities and medically underserved.

August 17, 2009

ENACCT recently attended a conference entitled, Health Equity: Through the Cancer Lens, jointly sponsored by the American Cancer Society's Office of Health Disparities and the National Medical Association. A highlight of the meeting was the release of the ACS-NMA consensus report: Cancer in Minorities and the Underserved.

The purpose of the report was to identify key trends in the national response to cancer disparities and put forth recommendations for future efforts and activities. The report covers a range of cancer issues, including prevention and screening, treatment, clinical research, and public policy.

We were pleased to see that the ACS-NMA report contains some of the same principles and strategies contained in the ENACCT-CCPH landmark report, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy, which includes detailed recommendations for engaging communities in specific and meaningful ways throughout the cancer clinical research process, with the goal of increasing participation of ethnic and racial minority groups in cancer clinical trials.

For example, the ACS-NMA report states:

• There remains a continuing need for the greater inclusion of minorities and/or low-income groups in clinical trials, so that new treatment options are fully tested using multiple ethnicities.
• ... One much-cited factor that leads to the continuation of health disparities across ethnic groups is the insufficient representation of ethnic/racial groups in clinical trials. In some cases, this insufficiency is expressed by the under-representation of minorities... Such outcomes suggest a need for a more intensive and effective recruitment of minorities into clinical trials.
• Outreach and education are needed to better inform health disparity populations not only about clinical trials, but about cancer as a general risk factor...Efforts are being made to address the inadequate participation of minorities in clinical trials. [Selected studies have] experienced exceptional success in the recruitment of both Latinos and African Americans into clinical trials through community-based strategies.
• Primary areas of [research] investigation must include healthcare system structure, clinical and basic science, and state and community assessment. The community-based research model should be more widely adopted.

It's encouraging to see another high-level report calling for action to improve cancer clinical trial participation, especially among minorities and the underserved. And more national groups advocating for community-based approaches to cancer research - as ENACCT and CCPH have done - is a step in the right direction.

August 5, 2009

The recent article, "Lack of Study Volunteers May Hobble Cancer Fight" by Gina Kolata, discusses the challenge of making progress against cancer in the face of low participation rates among adult cancer patients. However, there are important aspects of this issue that were not sufficiently addressed.

First, the notion that patients are not interested in clinical trials has been refuted. In fact, a 2003 study of American adults by Comis and colleagues in the Journal of Clinical Oncology found that 32% of respondents indicated that they would be very willing to participate in a cancer clinical trial if asked to do so. An earlier study by Comis and colleagues in 2000 highlighted the importance of patient awareness; eighty-five percent of cancer patients surveyed were unaware that clinical trials were a treatment option. Secondly, while trial participation rates are lower among medically underserved populations, this, too, cannot be attributed primarily to disinterest. A recent analysis (Wendler et al) of research studies indicated that minorities may be as willing to participate in research, but are less likely to be asked.

We believe that the principles of social justice demand that all eligible individuals be offered the opportunity to participate in clinical research, ensuring that both the potential benefit and burdens of research participation are shared among all groups. In ENACCT's experience, one way to address this is through ongoing community based education about cancer clinical trials. Enhanced public awareness--before the point of diagnosis and especially among minority communities--may translate to greater acceptability of a clinical trial when it is presented to a patient as an option. We must also help primary care providers understand more about cancer clinical trials, as they can play a valuable role in proactively making early referrals to oncologists that offer cancer clinical trials.

Ms. Kolata also leaves the impression that clinical trials are most appropriate for those who choose it as a last resort. While some cancer patients may be open to joining a trial when other options are no longer feasible, these should not and need not be the only patients who should be the focus of recruitment efforts. Since all patients in phase III trials receive at least standard treatment, cancer clinical trials can be a quality treatment option to many different kinds of patients-even for those receiving their first treatment.

Finally, the article describes two main options for addressing the challenge of low participation-either offering more incentives for doctors and patients or streamlining studies to result in smaller sample sizes. While we certainly support these ideas, in the communities in which ENACCT has worked, we have found that improving the quality of the patient-provider encounter when discussing the possibility of clinical trial participation is paramount. Clinical trial staff that is well trained in providing culturally competent, patient-centered care can more successfully recruit patients of all backgrounds by adequately addressing the cultural, linguistic, psychosocial and resource needs of the patient as they consider their treatment options. As for the second solution offered, utilization of smaller, later-stage study samples may in fact provide a more efficient means of completing a study, but should nevertheless be considered carefully. Sacrificing more diverse research participation in the name of expediency may result in limited generalizability for the population as a whole.

With recent reports estimating that approximately 40% of NCI's Phase III treatment trials are closing early due to poor accrual, something must be done to change the current paradigm. Improving rates of participation is no doubt a demanding goal, but with greater community engagement, improved health care system infrastructure and sustained commitment by researchers to enhance recruitment strategies, accelerated progress against cancer can be achieved.

July 17th, 2009

A recent article published online in the Journal of the National Cancer Institute suggested that even when African American obtain equal treatment through a cancer clinical trial, they are less likely to survive certain cancers in comparison to whites (Albain KS, Unger JM, Crowley JJ, Coltman CA Jr, Hershman DL. Racial Disparities in Cancer Survival Among Randomized Clinical Trials Participants of the Southwest Oncology Group. J Natl Cancer Inst. 2009 Jul 15;101(14):984-92). Specifically, disparities in prostate, breast and ovarian cancers appeared to remain. No significant outcome differences were observed in cancers of the lung, colon or blood.

Some researchers who have reacted to the study view these findings as significant in advancing the argument that genetics play a major role in worse survival rates. Others are skeptical and express concern that taken at face value, these findings could lend to support to those who believe in genetic inferiority of some groups over others. They note the role that environmental factors and other issues can play upon African American cancer patients long before they present at a patient, but that can have real implications for how well they fare in treatment. So which argument is correct?

It is important to acknowledge the role that external factors can play. Disparities in environmental exposures, rates of obesity and chronic experience of psychosocial stress could indeed make an impact, long before a patient receives "equal treatment". A lingering question, however is why differences in outcomes seem to disappear for certain cancers (such as lung and colon, as noted in the article) but not in the case of prostate, breast and ovarian cancer. Could it be that the variable environmental exposures have a different gene interaction and expression for certain cancers but not others?

And what do we really mean by "equal treatment". It is merely the technical administration of the same drugs or the same surgical procedure? Does it take into account the comprehensive experience of African American cancer patients in the health care system and what variations in interactions may exist in this regard?

It may be too early to say that whether or not genetics are in fact the ultimate source of racial/ethnic differences in outcomes. There is much more to be discovered about whether differences in African American outcomes are due solely to inherent genetic variations, whether its due to the extent to which the genes are impacted by environmental factors leading to changes in outcomes, or both. The bottom line, however, is that findings such as these raise further important research questions that need answers to ultimately lead to completely equal cancer outcomes. Increased participation in cancer clinical trials, including among racial/ethnic populations and the medically underserved is key to making this happen.

A recent article in the NCI Cancer Bulletin titled, "A Sense of Urgency: Rethinking the Clinical Trial Development Process", makes a plea for a drastic overhaul of the cancer clinical trial process. Specifically, the article calls for accelerating the timeframe from trial concept to the opening of a study for patient recruitment. The article refers to findings recently presented by Dr. Steven Cheng at the 2009 American Society of Clinical Oncology Annual Meeting. Dr. Cheng and his colleagues reviewed more than 550 adult treatment trials from the NCI's Cancer Therapy Evaluation Program. Among these, forty percent failed to reach their recruitment goals. Dr. Cheng's study went on to find that trials with shorter activation times (less than a year from concept to study activation) were more likely to be successful in meeting accrual goals) in comparison to start-up times of 1-2 + years in length.

Such delays have serious implications for how quickly we can make progress in cancer care and can needlessly squander valuable research resources. Every effort should be made to examine the challenges that exist in the current paradigm and look for ways "outside the box" to close this gap. Over the last few years, ENACCT has been doing its part to draw attention to the need for this paradigm shift through its efforts such as the "Communities as Partners" project. As a three-year, federally funded project conducted in partnership with Community-Campus Partnerships for Health (CCPH), "Communities as Partners" has explored the potential for integrating Community Based Participatory Research (CBPR) principles into therapeutic cancer clinical research. In September 2007 and March 2008, ENACCT and CCPH assembled a diverse group of stakeholders to develop a strategic plan for improving accrual rates and addressing persistent disparities in multi-site phase III cancer clinical trials. In October 2008, a landmark report on community engagement in cancer clinical research, Communities as Partners in Cancer Clinical Trials: Changing Research, Practice and Policy was released. The report includes more than 50 recommendations for engaging communities in specific and meaningful ways throughout the clinical research process in order to:

• reduce barriers to diverse participation in cancer clinical trials (CCTs)
• build partnerships that utilize innovative approaches to increase recruitment and retention in cancer treatment clinical trials, especially among ethnic and racial minority groups; and
• ultimately increase participation of ethnic and racial minority groups in CCTs.

If you haven't already done so, I invite you to read the report. All of us -- whether community leaders, patient advocates, primary care providers or members of a cancer research team -- can play a critical role in helping advance the process of cancer clinical trials to achieve the highest quality cancer care possible.

June 30th, 2009

Two male cancer patients - similar cancer, background, insurance - visit their doctors for routine care related to their cancer treatments. The insurance company covers the costs of one of the patients but not the other, why?

This past spring, Texas became the 26th state to approve legislation requiring health insurance companies to cover routine patient care costs associated with a clinical trial. These costs do not include procedures conducted for research purposes or include costs that would not normally be covered for patients not enrolled in a clinical trial. Instead, routine costs include doctor visits, hospital stays, x-rays, lab work -- care that would normally be covered for patients but is denied to many due to being enrolled in a clinical trial.

Clinical trials are vital to cancer research; today's clinical trials are tomorrow's standard treatments. Currently, only 3% of all eligible patients are enrolling in trials, resulting in many closing early or never even getting off the ground. With the current economic climate and rising costs of health care, the fear of even routine care not being covered by insurance companies creates a significant barrier to clinical trial enrollment. Legislation such as that recently passed in Texas, greatly reduces this barrier and increases access.

I am proud to say that two of our colleagues from the Tacoma, Washington PEP site are working to achieve similar legislation in Washington. Samantha Yeun and Jay Zatzkin have been working from within the Washington Comprehensive Cancer Control Partnership to educate on the important role cancer clinical trials play in cancer research and treatment development. In part due to their efforts, one of the partnership's current objectives is to advocate for the state of Washington to pass legislation mandating insurance coverage of routine medical costs for those enrolled in cancer clinical trials. We have high hopes that not only Washington, but the other remaining 24 states follow suit and pass similar legislation so that my earlier story becomes that of fiction in all 50 states.