March 14, 2011— -- Haralee Weintraub of Portland, Ore., was 48 when a routine mammogram changed her life forever.
Textbook breast cancer, her doctor called it.
"She literally showed me a textbook and my mammogram side-by-side," Weintraub, 58, said. "There was no need for a second opinion."
Surgery revealed that the tumor was bigger than anticipated and had already spread to nearby lymph nodes. The standard treatment, Weintraub was told, was chemotherapy. But she wanted to know how she could help, and "be an active participant rather than a passive patient."
"My doctor said there were some clinical trials and asked if I would be interested," Weintraub said. "I said yes."
Weintraub enrolled in a trial testing the effectiveness of a new chemotherapy drug. And in the 10 years since, she has participated in four more.
"My reasoning was it could help me as well as other women," Weintraub said.
Weintraub's motives are common among clinical trial participants, said Dr. Susan Love, president of the Dr. Susan Love Research Foundation, a nonprofit organization based in Pacific Palisades, Calif., that promotes and funds breast cancer research.
"I think, in general, the people who participate are altruistic," Love said, adding that she thinks women with breast cancer are particularly generous. "If they can help someone else, they're willing to do it."
But across cancers and a range of other life-threatening diseases, researchers struggle to recruit enough patients for trials to generate meaningful results.
"I think there's a fear that you might get a placebo or that the treatment might have adverse effects," Weintraub said.
Clinical trials are a crucial step in the search for disease treatments, tests and causes. But fears, misconceptions and a lack of awareness -- among patients and doctors -- are major barriers that researchers across all fields are working hard to overcome.
"In just about every major disease, less than 10 percent of patients are enrolling in trials," said Dr. Richard Bedlack, director of Duke University's Amyotrophic Lateral Sclerosis Clinic in Durham, N.C.
Bedlack said only 5 percent of people with ALS (or Lou Gehrig's disease) -- a fatal neurological disease with no cure and only one treatment that extends the average 3-to-5-year survival only slightly -- enroll in clinical trials.
Breaking Down Barriers
Bedlack has been studying what motivates people to participate in trials and what dissuades them from signing up. Patients worry that participating in trials will spur out-of-pocket expenses, impose heavy time burdens and possibly expose them to dangerous or unethical procedures, according to a survey he presented in December at the 21st annual International Symposium on ALS-Motor Neuron Disease in Orlando.
Websites touting bogus treatments and trials abroad also hinder research efforts in the United States.
"I'm trying to compete with a so-called 'clinic' in India professing to cure someone with stem cells by saying I have a trial that might modestly slow down someone's disease," Bedlack said.
In addition to the chemotherapy trial, Weintraub has participated in studies investigating the role of genetics and exercise in cancer recovery, and the effects of chemotherapy on vision and falling.
"When you're in a trial, you get followed so closely that it's just like having your own personal health team," Weintraub said. "I think if people saw it that way, it would take out some of the fear."
Many trials cover the cost of expensive tests and treatments, and even subsidize travel to and from the trial centers. Weintraub said the trials actually helped mitigate her out-of-pocket expenses (which could have reached $10,000) by covering the cost of expensive drugs and frequent tests.
"All that data is all sent to my primary care doctor, my oncologist," she said. "Everyone is on board with the program. You're so closely monitored."
So much so that her primary care doctor once said a routine exam was unnecessary.
"He told me there was no need, and to save my money," she said. "Thank you, clinical trial."
As for the time commitment, Weintraub said, one trial (studying genetics) required that she fill out a few forms and give some blood. Another (studying vision) had her take eye drops and come in for two check-ups.
"Usually, it's not that big a deal," Weintraub said, adding that she often had to give blood for other tests anyway.
Importance of Doctor Support
Weintraub said her doctor's enthusiasm about the trials made her confident in her decision. But not all doctors are so keen.
"Doctors generally don't like to admit that we don't know the right answer," researcher Love said. "And a 'trial' implies that we don't know the right answer."
Lack of awareness and worries about time burdens and paperwork dissuade doctors from recommending trials, too, Bedlack said. Many doctors go with the standard treatments, and don't even mention trials unless asked.
"When you're first diagnosed, you're scared to death and you'll pretty much do whatever anyone tells you," Love said. "You desperately want the doctor to have the answer, but the way medicine progresses is by us continuously doing these kinds of studies."
Certain websites, such as clinicaltrials.gov and cancer.gov, have information about ongoing trials and how to get involved. But women diagnosed with breast cancer have limited time to make a treatment decision, and searching for a trial might not be at the forefront of their minds, Love said.
To make it easier to get involved, Love teamed up with Avon to launch the Army of Women; an effort to recruit 1 million women of every age and ethnicity, including breast cancer survivors and women at high-risk for the disease, to participate in breast cancer research.
"What we're hoping to do is develop a way that if they're diagnosed, they let us know and we can let them know about opportunities," Love said. "That way the information gets out there in more of a 'push' way as opposed to women having to search it out."
Weintraub now designs, manufactures and sells Cool Garments for Hot Women -- moisture wicking sleepwear for women who have night sweats because of breast cancer or menopause. She uses other breast-cancer survivors as models, and donates a portion of every sale to breast-cancer research.
She said she'll continue to help move medicine forward by participating in trials and encourages others to do the same.
"It's so important," she said.