Bridging Gaps, Expanding Outreach: Identifying the Unmet Needs of Women Living with Metastatic Breast Cancer

The purpose of this Priority Report is to raise awareness of metastatic breast cancer (MBC), identify some of the obstacles women living with this disease face, and understand how we as a community can address the unique informational and support needs of these women. The narrative is told primarily by individuals involved with the support of women with MBC.Little did former First Lady Betty Ford, wife of the late President Gerald Ford, know she would start a revolution of sorts by discussing breast cancer so openly and frankly in public back in 1974.

By speaking forthrightly about her disease and her subsequent radical mastectomy, Mrs. Ford, who turned 90 in April, hoped to raise awareness about the disease and the importance of breast exams, and put a face on what was once a woman’s disease, spoken about in hushed, embarrassed tones. Seventeen years later, Mrs. Ford’s efforts had evolved into one of the most successful brand symbols of all time: the pink ribbon. Although many ribbons of various shapes and sizes had existed before—from yellow ribbons tied on trees in support of soldiers overseas to red ribbons on the lapels of celebrities against AIDS in the late 1990s— pink ribbons replaced pink visors at the 1991 annual Susan G. Komen “Race for the Cure,” and a movement began. Today, the pink ribbon’s symbol and color are still a successful representation of the fi ght against breast cancer.

After more than one-quarter century of the pink ribbon movement, however, some wish the pink ribbon would lengthen its reach and wrap itself around more women and families whose lives have been changed by breast cancer, namely, those with MBC.

Breast cancer remains the leading cause of cancer death among women worldwide—close to 500,000 women will die of the disease annually, and an estimated 1.3 million new cases will be diagnosed internationally.¹ In the US, an estimated 182,460 new cases of breast cancer are expected to occur among women in 2008,2 and 30% of these cases will eventually develop into metastatic disease.³ Yet despite these numbers, some women with MBC say they feel invisible compared to women with less advanced forms of breast cancer.

“When we are remembered, we are recognized as losing the battle,” one patient with MBC poignantly says. “We are what the pink ribbon crowd wants to forget, because we are the painful reminders of what can happen.”

Feelings of isolation can become particularly intense in October (Breast Cancer Awareness Month in some countries). Women with MBC say the media prefers to cover “happy endings,” stories of women detecting breast cancer early, having the tumor removed, and going on their way. They may be right.

“Every October, the pink ribbons come out, and every October, women with metastatic disease are not spoken about in a very tailored or personalized manner,” said Elyse Caplan, MA, Education Director of Living Beyond Breast Cancer (LBBC), a patient advocacy organization headquartered in Haverford, Pennsylvania. Women with MBC want information and resources that speak to the challenges of their stage of disease. Why is it so hard, they wonder, to find survival statistics? What are their clinical trial options? How do they navigate an often confusing and confl icting sea of information?

Breast cancer professionals from all disciplines are trying to answer these questions, starting with the basics: identifying the needs and wants of women with MBC; developing ways for those most closely involved with these women (doctors, nurses, caregivers) to meet those needs and wants; conveying information more cohesively to both medical professionals and patients; and changing the perception of clinical trials—from one of a “last chance” to one of an additional tool in living with the disease.

Women with Metastatic Breast Cancer

In 2006, LBBC conducted a U.S.-based “Needs Assessment Survey,” which concentrated on learning the needs of women with MBC with a focus on how the women gathered information and how they applied it to their lives.⁴ Ms. Caplan expressed surprise at the number of women who responded to the survey and believes it spoke volumes about the subject.

“Much to our surprise, even though we did pare it down to only 64 questions, it still took about 40 minutes to complete,” said Ms. Caplan. “We had expected about 200 respondents; we had well over 600 (online). So that proved my personal point that, if you ask women with MBC what they want, they will take the time to tell you.” The responses, according to Ms. Caplan, are testaments to “isolation, feeling alone, and the need to have their voices heard.”

Virtually all of the women surveyed placed great value on access to information related to the treatment of MBC, such as side-effect and symptom management, stated Ms. Caplan. To them, information means support and established control in coping with their disease. This also included a desire to know about clinical trials available to treat their disease. Some 84% of the women said they thought information about clinical trials was “important,” yet less than half (39%) sought information on them.⁴

Additionally, many who completed the LBBC survey said they didn’t know where to fi nd information about MBC educational programs either in the community or on the Internet. Those who did, cobbled their information together from a variety of sources like books, brochures, handouts, government websites, and articles from medical journals. “Here we have women who highly value information about MBC, but they can’t find it,” Ms. Caplan said. “This is striking, because demographically the survey respondents generally had higher levels of education. So, you’ve got knowledge-seeking women not knowing where to go. We need to do better.”

Along with this desire to have more accessible information about their disease, women with MBC who participated in the LBBC survey shed insight on another potential hurdle in information access—reaching women at the right time. More than one-half (56%) said they are most likely to seek information when they are experiencing discomfort and side effects from their disease, but less than one-half (44%) do so when they feel worried or sad.⁴ This would seem to strongly indicate a need for information providers— doctors, advocates, and other healthcare information providers—to try to predict not only the kind of information women with MBC are likely to seek, but when and where they are likely to seek it.

A Team of Their Own Reaching the right women at the right time is challenging. Most professionals acknowledge that large, well-funded campaigns like the Susan G. Komen for the Cure (formerly known as Susan G. Komen Foundation’s Race for the Cure) and the Avon Walk for Breast Cancer have gone a long way toward raising awareness about breast cancer in general, removing the taboo of discussing it, and urging women to be more vigilant about their own health. The next step, however, needs to be to tailor awareness and information to women who are at different stages of breast cancer, including those with advanced disease.

“The initial launch of the pink ribbon campaign [raised] awareness of the disease and [gave] it a face,” said Pat Kelly of the Campaign to Control Cancer in Canada. “But now there’s a second phase of the campaign, and that is to recognize that this is a chronic disease and there are transcendent issues around clinical trials and patient navigation that would be appropriate for women at any stage. We’re not just asking people to give money, or wear a ribbon— we’ve got a little bit more for them to do in terms of accrual to clinical trials and systematic improvements in ensuring access to [patient] quality care.”

Chronic, not Cured

“I’ve been a MBC survivor for eight years, but breast cancer policy discussions all seem to focus on fi nding a cure,” said Lilla Romeo of the Metastatic Breast Cancer Network, based in New York City. “That would be wonderful, but we also want to hear more talk about extending lives, because anyone with MBC has gone beyond fi nding a cure. We need to know about drugs that will extend our lives—that is what every single person with MBC is seeking.”

Facing this reality makes women with MBC more interested in quality of life issues when deciding whether to enroll in potentially life-extending trials. When looking at a clinical trial, a patient is likely to ask many questions that pertain to quality of life and side effects. The medical community, advocacy groups, clinical trial coordinators, and corporations that provide the funding for outreach must work together to answer these types of questions. New ways to identify and bridge these gaps are getting attention, and many of them involve taking advantage of the Web and other emerging media—like interactive video chat and social networking websites—and offline resources to give women information when they need it and want it. Dr. Marisa C. Weiss, president and founder of Breastcancer.org and a practicing oncologist in the Philadelphia area for over 20 years, said the Web has become an essential 24/7 resource for many women with MBC. “There are relatively few support groups for women with MBC, but at breastcancer.org there are thousands of conversations going on in community discussion boards, day and night, all around the world. That online connection ends up being the most common source of support groups for women with MBC.”

Navigating the Journey from Many Directions

A cancer navigator assists patients and their families throughout the entire cancer care continuum, including directing patients to resources for diagnosis, treatment, and recovery.

Navigation programs also offer support to meet each person’s specifi c needs. “A woman who has just been told her breast cancer has returned or has metastasized wants information that speaks to her phase of this experience,” said Ms. Caplan.

Navigators will become even more important as cancer care becomes more and more personalized, according to Dr. Weiss. “When we talk about the world of breast cancer, we realize how many different groups there are within that one term. Particularly women with metastatic disease— each one is an individual.”

Navigators also help patients understand their diagnosis. Many groups of breast cancer advocates, health care professionals, and others have the information they seek about their care decisions—but how do women know which group to go to? To quote one advocate: “Patients have enough to deal with getting through the ‘day to day.’ They shouldn’t have to work hard to access the information they need.”

What if each group talked to each other and worked together to increase support and access to information that could reduce anxiety for women with MBC and, hopefully, help them continue with their “everyday” lives? Greater efforts to synchronize and streamline that information— whether from the Internet or elsewhere—could go a long way to make information easier to get to. It is reported that 73% of women with MBC seek disease information on a daily or weekly basis,⁴ and 86% said better use of Web-based educational and support materials would be helpful.⁵

Collaboration, not duplication or competition on the Web, is getting more attention from smaller breast cancer groups. With each group struggling for limited resources, “best practices” are being sought and copied in a spirit of cooperation. “Several years ago we created a section on our website on MBC,” says Jackie Manthorne, Executive Director of the Canadian Breast Cancer Network, based in Ottawa, Ontario. “It is quite highly used, and I know that other organizations in Canada have done the same thing. I think we need to grow these and I think we need to share information. We’ve always said ‘take what you want, just don’t create our site over again.’”

Online Options

Not everyone is “online” these days, but those who are possess different levels of Internet literacy. Some information is written for medical professionals, some for patients, and some for a little of both.

“Many women in the metastatic population are older... and do not use the Internet as much as many of us who are sitting here today,” said Ms. Romeo. One possible solution: a printed guidebook for use on and off the Internet, including where to fi nd information about enrolling in clinical trials. Some medical centers and pharmaceutical companies have already developed “navigation” tools that people without Internet access can obtain, “like a one-on-one coach” whether online or off.

“One of the greatest sources of information besides the Internet is nurses,” said Pat Spicer, Breast Cancer Program Coordinator for Cancer Care, based in Woodbury, New York. “When we send out information, they are the ones who are the most active in handing out our pamphlets and promoting our programs. We need them to be a greater part of this, because they’re really good at it.”

One-on-one interaction with health care professionals, including nurses, varies greatly, however, because—like their patients—nurses possess different levels of knowledge or may be affected by the particular culture of their offi ce. Access does not always equal accessibility, according to one MBC survivor.

Ms. Romeo, who has been receiving chemotherapy for eight years to treat her MBC (with only an 8-month break in between) speaks from experience: “I live in New York City, so there’s no problem with access. Still, the doctor has about 15 minutes to see you, and as you’re walking out the door you remember you didn’t ask him this or he didn’t answer that. But you know that while you’re sitting in the infusion room for the one hour, two hours, five hours, depending on what treatment you’re on, there will be plenty of time to ask the nurses those questions.”

Ms. Caplan, who was diagnosed with early stage breast cancer, agrees. “I was diagnosed with breast cancer 16 years ago...my oncologist spent 45 minutes with me. That doesn’t happen today. It hasn’t happened for years. The nurses who administer treatment are the ones who are face-to-face with you for longer periods of time.”

Even within one country or province, the information chain can vary greatly. For example, breast cancer networks in several Canadian provinces have created breast cancer kits that are given out to the newly diagnosed by family doctors, oncologists, or pathologists. In addition, patient navigators working in some provincial breast screening programs, cancer centers or hospitals automatically contact newly diagnosed women to communicate what resources are available to her while navigating her treatment plan. “It isn’t the patient who actually must find out about the navigator,” said Ms. Manthorne. “The navigator automatically finds out about the patient.”

The telephone is still an effective way to reach and teach women with MBC what their options are. In fact, the telephone becomes a particularly important tool of communication—if not the only tool—for many women with MBC who do not live in Westernized nations.

“There were more than 1,600 people listening in on the last educational call we did,” said Ms. Spicer. “Those calls extend all over the world...we’ve had people from Thailand, from Africa, and from the more developed countries. Women gather in groups to listen on one phone occasionally.” Phone “support groups” can also be a valid alternative to women in Westernized countries as well, simply because they may not feel well enough to leave home.

Clinical Trial Enrollment

If reaching and teaching women with MBC about the disease and their treatment options is a challenge, enrolling them in clinical trials is even more so. This problem has been studied by leading cancer researchers for several years now, and the cancer community is seeking ways to encourage people, including those with MBC, to enroll in trials to test potentially life-extending treatments.

There are several points of disconnect between the importance of clinical trials and patient participation. According to a study published in the Journal of Clinical Oncology, a majority of cancer patients say they are receptive to the idea of enrolling in clinical trials, yet only 2%—4% actually do so.⁶ One reason may be because patients are not aware of them. Many physicians—who are in the best position to recommend patients for enrollment—say they support clinical trials. Yet, a patient survey found 85% of patients were unaware clinical trials were even an option for them.⁷ This seems to indicate a large communication gap between doctors who are aware of trials and the patients who would like to be made aware of them.

“One of the things I hear is that doctors don’t explain clearly what the trial is about,” said Ms. Spicer. “Their doctors say ‘Here, take this consent form home, read it, sign it,and bring it back to me.’” Change is beginning, however. One European-based MBC support group, for example, is developing a DVD for patients enrolling in an especially complicated trial, complete with a written consent form.

Clinical Trials: What’s In It For Me?

Women with MBC can get information about clinical trials on their own, from such websites as clinicaltrials.gov, the clinical trials page of the National Cancer Institute, and others, but the presentation of information varies greatly and can confuse and overwhelm even highly educated women. Women who do successfully uncover and decipher information about clinical trials may still have misgivings about enrollment.

Clinical trials, especially for cancer, still have an air of a “last resort” choice for many people. Potential enrollees are also concerned about being placed in the placebo arm (or, as in the case of cancer, only receiving the “standard” care and not the investigative treatment or becoming a “guinea pig”), according to studies from The Lancet and others.8 Overwhelmingly long and confusing consent forms or diffi culty with physical access to the trial site can also prevent even the most motivated women from enrolling.^8,9 In the U.S., there are currently an estimated 56 Phase 3 studies that are open and enrolling women with stage 4 breast cancer, and some 30,000 patients are needed to fi ll them.¹⁰

Addressing the gaps and disconnects is one thing, but convincing women with MBC that their participation in clinical trials is worth their precious time is another. One advocate sums it up in three simple words: “Extend my life,” Ms. Romeo said. “That’s the message women want to hear about clinical trials for MBC, but many of these trials have too many limitations for entry. Your expectation of hope is raised, and then you discover that if you’ve been through eight types of chemotherapy, or even just three, you don’t qualify for any trials.”

Care must be taken, advised Ms. Kelly, to have other options ready for those women who don’t qualify for clinical trial entry and to make sure these options are clearly and sincerely conveyed to them. “Rejection is really a tough issue when you have advanced disease.”

The lack of clinical trial participants is affecting research as well. The Center for Information & Study on Clinical Research Participation, located in Dedham, Massachusetts, estimates that if enrollment in clinical trials increased by just 10%, most could be completed in one year instead of three years or more.¹³ The quicker a drug can be determined effi cacious or dropped, the faster resources can be released to pursue more studies.

Removing Barriers, Building Bridges The good news is that people involved with patients who have MBC—from health care professionals to support groups and patients themselves—are not only recognizing the barriers women with MBC face, but they have many ideas on how to break them down and make these women feel more in control of their destinies.

One of the first orders of business, MBC advocates say, is to establish a unique presence among people battling cancer and among patients with MBC in particular. This means putting a “face” on the disease in both a literal and figurative sense. Elizabeth Edwards (wife of former presidential candidate John Edwards) has been public about her battle with MBC, and serves as one example of how a person can lead a productive life with the disease. It also means getting the attention and fi nancial support of large corporate foundations and political leaders who have already demonstrated their commitment to breast cancer awareness through the pink ribbon campaigns, marathons, and other initiatives.

“They [corporations] are not going to listen if we just have a meeting and sit around a table,” said Donna Sheehan of Willow Breast Cancer Support in Canada. “They want to see that something is happening. They need to see there’s a movement, that something is starting, and they’ll have no choice but to jump on.” This would be easier, she said, if a position statement existed among advocacy groups that is general and broad but clearly points to the need to consider the issue of MBC.

Such a statement must bring new awareness of MBC to groups who may not have previously been as involved or invested in it. Care must be taken to convey that, while a diagnosis of MBC does not mean a near-term death, it is still a serious, incurable condition. The message must be one of realistic hope for women with MBC but at the same time not strike fear into the hearts of those with earlier or less-serious forms of breast cancer.

Changing how information on MBC is delivered is another way, advocates say, to elevate awareness of the disease in the general population and specifi cally reach women with MBC. Using both new and traditional ways of communicating this information, including education about clinical trials, is key, as is a unified statement of purpose.

“A consensus guideline with specific targets—inclusive of both patients and professionals, nurses, grassroots organizations, Komen and all of us involved in raising awareness about breast cancer—is needed,” said Ms. Kelly. “[We need to raise] awareness specifi cally about the need for a full range of standards and guidelines for the treatment and care of MBC. Once consensus has been reached, we need to have a broad-based communication venue among ourselves to let everyone know what the consensus is.”

When it comes to one-on-one recruitment for clinical trials, even the most powerful consensus statement will not draw women with MBC in. For this part of the equation, a push/pull strategy must be in place—a “pull” from the professionals on the front lines, and a “push” from the patients.

“One of the biggest drivers of clinical trial enrollment is the patients themselves,” says Dr. Weiss. “Women have to ask for them and may even have to be pushy and speak up about enrollment when they think about what is at stake.”

When the patients do speak up, Dr. Weiss said, the medical team should be ready with answers. “The number one item that will help in the accrual and recruiting process is for the physicians, the nurses, and whoever is going to really have the direct contact with the patients to be trained to do so properly so that information about clinical trials doesn’t come across with the wrong kind of impression,” said Dr. Weiss, who stated that professional lectures, continuing medical education and listening to patients are all ways community oncologists can stay on top of clinical trials just as well as any major medical university.

“I always like to stick to the facts to dispel myths and supply understandable, relevant information and facts to encourage people to participate in clinical trials,” she said. “These facts are then distributed through people, breast cancer organizations, and the media. [Also] the fact is people tend to do better on clinical trials than off. They have the opportunity to get better than average care. These types of facts are very encouraging and get the patient to drive the process by asking the doctor and making sure she gets good answers to her questions.”

If doctors do not have the time to tell each patient about clinical trials they may be eligible for, it is up to his or her support staff to deliver the information in person as well as provide comprehensive, easy-to-understand, take-home materials for patients to review when considering a clinical trial.

Speaking from experience, Susan Knox, Executive Director of Milan, Italy—based Europa Donna, the European Breast Cancer Coalition, agreed. “The physician will not have time, so in one of our programs we specified physicians had to have at least trained research nurses or research fellows on teams that would introduce material [on clinical trials] and initially explain it to patients with a nurse or the physician present.” This takes into account what most health care professionals and patients know: with their minds racing on a million different things, patients often can’t remember or absorb everything they need to know when they have the doctor sitting in front of them. Take-home materials reinforcing the information are essential.

Health care professionals, advocates, and patients agree: women with MBC face many challenges, both physically and mentally, which women with earlier forms of breast cancer do not. Furthermore, whereas breast cancer awareness is higher than it has ever been, women with MBC sometimes feel that they are not part of this group.

Things are starting to change, however, not just for patients with MBC, but for many patients with complex diseases who need guidance and support during their journey. The Patient Navigator, Outreach and Chronic Disease Prevention Act of 1995 allocated $25 million to help medical centers develop patient navigation programs for those with chronic illnesses, including those with MBC, and positive results are already emerging.¹⁴ Funding and support is beginning to come from both pharmaceutical companies and other corporations that have taken early leadership roles in raising breast cancer awareness, including the Ralph Lauren Center for Cancer Care and Prevention in New York City.

Women with MBC want to concentrate their precious time and energy on maintaining their health, quality of life, and everyday living. Finding information on how to take control of their disease, including information about clinical trials, should not take up any more of their time than necessary. With creative collaboration between the medical and advocacy fi elds, there is more hope than ever that barriers will be become bridges to help women with MBC lead fuller, longer lives.

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References Global Cancer Facts & Figures 2007Cancer Facts & Figures 2008Current Challenges in Clinical Trial Patient Recruitment and EnrollmentBreast Cancer Facts & Figures 2007-2008CISCRP’s 101 Facts about Clinical ResearchASBD Advisor