Acronym alert! Chroniclers of cancer organizational changes need to update their glossaries to include one of the newest entries created to meet yet another unfilled need—effective community accrual and retention of patients to cancer clinical trials by increasing community literacy.
The Education Network to Advance Cancer Clinical Trials, (ENACCT) is the latest nonprofit organization founded by an advocate who left an established entity to work on similar projects outside what was perceived as the confines of a more bureaucratic structure.
The Silver Spring, Maryland-based ENACCT was launched earlier this year by Margo Michaels, MPH, former Branch Chief of Survivor and Public Education in the National Cancer Institute's Office of Education and Special Initiatives.
The organization was founded with seed money from the Lance Armstrong Foundation (LAF), said LAF's Associate Director of Public Health, Andy Miller, MHSE, CHES, who noted that LAF has not had a specific program devoted to clinical trials, and ENACCT was a good match since it would address clinical trials issues related to LAF's mission of survivorship.
Ms. Michaels, ENACCT's Executive Director and President, has spent the last decade developing educational programs about policy and scientific issues related to cancer and cancer clinical trials for cancer advocates, community leaders, and health care professionals at the NCI, the Susan G. Komen Breast Cancer Foundation, and the National Breast Cancer Coalition.
During a telephone interview, Ms. Michaels explained the rationale behind ENACCT.
“We're unique and different from other organizations in our approach to cancer clinical trial education,” she said. “Today, only 3% to 5% of adult cancer patients participate in clinical trials. There are many issues dealing with why we can't get enough people to accrue to trials, especially people of color, and there are many reasons for that.
“Resources for local support aren't usually available, NCI doesn't support them, and most local institutions don't or can't support them.”
Although virtually all discussions on the topic call for increased education of both the public and physicians, little money has been available, and Ms. Michaels said that previous efforts had been inadequate.
“I don't believe the kind of education that needs to happen should be through big PR campaigns,” she said. “I believe access to clinical trials and education about clinical trials is a trust issue. It's a local issue, and peers need to talk to peers about it at the local level if attitudes about clinical trials are to change.”
Ms. Michaels is merging her background in community organizing and adult education with her experience in clinical trials education to create what she considers a new model to help change those attitudes.
She said community members need to talk to other community members, doctors to doctors, and social workers to social workers, and that it's important to enhance clinical trials awareness before a diagnosis takes place, since there's a very narrow window of time between diagnosis and treatment.
To that end, ENACCT, through funding by LAF, has started a pilot education program—“a comprehensive, community-centered outreach and education effort to address the issues of community literacy around clinical trials,” Ms. Michaels said. The goal is to change knowledge, attitudes, and beliefs and intention among both health care providers and community leaders in a way that will ultimately enhance and increase accrual to clinical trials.
“In the spectrum of clinical trials education, community response has never been attempted,” Mr. Miller said. “The existing programs are mostly national in scope, and there's a growing movement around cancer control coalition work in every state, with many community-based coalitions serving as adjuncts.”
The pilot program will run for five years, with the first year devoted to implementation, and the fifth to evaluation. Three grants of $150,000 a year for the middle three years, the intervention component—totaling $1,350,000—will be awarded through a national competitive award process by ENACCT, which will provide awardees with ongoing technical assistance, evaluation, and training services.
The deadline for preliminary applications has already passed, and the three successful applicants will be notified by December, with funding to begin in January.
Summit Series on Cancer Clinical Trials
I first learned about ENACCT's partnership with LAF from a joint news release issued this spring announcing the pilot program, and I knew Margo Michaels in her NCI role as a participant in the annual Summit Series on Cancer Clinical Trials.
Since starting in 1998, the public awareness campaign sponsored by the Summit has increased enrollment in NCI cooperative group trials by 30%, said Carolyn “Bo” Aldige, President and Founder of the Cancer Research and Prevention Foundation, and one of the original conveners of the ongoing Summit Series.
Message to NCI Consumer Advocates in Research and Related Activities
However, my interest in ENACCT piqued considerably in June when I received an e-mail message from NCI to members of its Consumer Advocates in Research and Related Activities (CARRA) program.
The e-mail told CARRA members of a unique opportunity to apply their expertise in community outreach, community partnerships, community-based participatory research, or clinical trials education as proposal reviewers for ENACCT's pilot project.
It was one of the few times NCI had alerted CARRA members about participating in projects with organizations with missions that overlapped with the Institute.
Ms. Michaels said that the Lance Armstrong Foundation had called a meeting this past May to discuss the pilot program with NCI Director Andrew von Eschenbach, MD, who was very supportive and made it possible for ENACCT to disseminate information about the program to all NCI grantees, including cancer centers and Community Clinical Oncology Programs, and to CARRA members, with the idea that in addition to serving as possible proposal reviewers, they could share the information with their sponsoring advocacy organizations.
Mr. Miller said that Dr. von Eschenbach's response was a validation that the program was going in the right direction.
Mr. Miller added that when LAF and its partners were involved in promoting Bristol-Myers Squibb's “Tour of Hope” initiative, each of the organizations that benefited from the fundraising efforts had to use the funds to advance cancer clinical trials through education or intervention. So when Ms. Michaels brought her proposal regarding the creation of ENACCT to LAF's attention in February 2004, the Foundation was interested.
Applicants for the pilot program grants must have proven track records of collaborative partnerships with community members, health care providers, and people affected by cancer for at least three years.
ENACCT uses a model developed by the New York Academy of Medicine that defines a community as a meaningful self-identified entity, more county-sized than statewide. Partnerships must be preexisting, and made up of community-based organizations that provide particular services such as social service agencies, food banks, and faith-based organizations.
This is the latest nonprofit organization founded by an advocate who left an established entity to work on similar projects outside what was perceived as the confines of a more bureaucratic structure.
“It's more important that they have the infrastructure in place than experience with clinical trials, which we can teach,” Ms. Michaels said.
“You can't build a coalition or partnership over night, and we don't have the luxury or time to help them get their act together during those three years; they have to have their act together before they start.”
ENACCT also believes you can't just throw educational materials at a community, but have to provide technical support as well, she added.
Losing Sight of Big Picture?
According to Ms. Michaels, many projects focusing on increasing accrual in cancer clinical trials are losing sight of the big picture by looking at just one particular trial or hospital or doctor, rather than increasing community awareness about the concept that quality care is not possible without an informed consumer, who knows that there is the option of participating in clinical trials.
The educational network is also planning to offer fee-for-service technical assistance and training programs to institutions interested in appropriately developing community relationships.
“You have great scientists and doctors thinking about the trial, but when it comes to getting patients involved, it's often left to nurses and clinical research associates,” she said. “Accrual and retention have never really been given very serious attention at the cooperative group level or NCI.”
The genesis for ENACCT grew out of a discussion between Ms. Michaels and Ellen Stovall, President and CEO of the National Coalition for Cancer Survivorship (NCCS) and a member of OT's Editorial Board; Kim Thiboldeaux, President and CEO of the Wellness Community; and Jane Reese-Colbourne, past Executive Director of the National Breast Cancer Coalition and a cancer organizational consultant, all of whom now serve on ENACCT's Board of Directors, as does Mr. Miller.
In fact ENACCT rents its office space from the NCCS, and shares its potential, partial, nonprofit, fee-for-service structure with the Wellness Community, which has developed an on-line Virtual Wellness Community model it has begun to export to other organizations for a fee.
“ENACCT has a multidisciplinary, diverse board [the names are posted on the Web site, www.enacct.org] made up of partners in cancer advocacy rather than fundraisers,” Ms. Thiboldeaux noted. “It's not a me-too organization, and with its partnership- and evidence-based model, ENACCT is structured to truly meet a need that is not duplicative—raising community awareness about the importance of clinical trials.”