Tamoxifen's impact on breast cancer provides hope - and misinformation
Health care professionals help patients sift through media hype
Some of the biggest news in breast cancer research hit the national media recently, provoking numerous questions - as well as misinformation - among women. Initial results of a five-year study of the drug tamoxifen showed a 45% reduction in breast cancer incidence among women who were at high risk for developing the disease.
Currently used to treat breast cancer, tamoxifen (Zeneca Pharmaceuticals, Wilmington, DE) was taken as a preventive measure for the study. More than 13,000 women participated. Half took tamoxifen daily, and half took a placebo. Forty percent of participants were ages 35-49; 30% were ages 50-59; and 30% were 60 and older. All age groups showed similar reductions in breast cancer. The National Surgical Adjuvant Breast and Bowel Project, in Pittsburgh, conducted the study, with support from the Bethesda, MD-based National Cancer Institute.
Because of the study's positive findings - and the resulting media hype - women are turning to women's health centers to explain information that has been unclear in the press. Can they take tamoxifen now? When will it be available? Can anyone take it? (See answers to these questions enclosed in this issue.)
The good news has overshadowed possible adverse side effects. Although rare, three life-threatening health problems - endometrial cancer, pulmonary embolism, and deep vein thrombosis - could result from taking the drug.
Some women's health centers are responding by educating women in their community or by connecting women to national resources, such as the Breast and Bowel Project or National Cancer Institute.
Sifting fact from fiction
According to Karen Kramer, RN, BSN, MHA, director of The Women's Center Breast Care Clinic of Cox Health Systems in Springfield, MO, the media's coverage of tamoxifen hasn't always been balanced or thorough.
"In fact, the announcements may have led people to believe that the medical community is ready to prescribe tamoxifen to any person for the prevention of breast cancer. At this time, it's not," she says.
Kramer says that medical professionals who are committed to helping women lead healthier lives need to be cognizant of "medical information overload."
"When women turn on the television, pick up a magazine, or log on to the Internet, they are barraged with information," she says. "It's a challenge for all of us in the medical field to get accurate information [out]. And it's a challenge to take new medical information and apply it to an individual women's medical history and personal needs.
To educate the public, the breast care center has summarized the study in its community health newsletter and press releases and presented information at its breast cancer support meetings.
"Our approach has been to make the community aware of the study and its significance to breast cancer research," says Kramer.
Centers also are involved in recruiting women in the community to participate in cancer research. Kramer says her center has encouraged women to consider participating and has referred them to a regional program, the Ozarks Regional Community Clinical Oncology Program, which was involved in the tamoxifen study. Also located in Springfield, the Ozarks Oncology Program is supported by Cox Health Systems and St. John's Health System for expenses not covered by the National Cancer Institute.
Securing 13,000 participants
Barbara Connolly, RN, clinical research coordinator at the University of Pittsburgh Cancer Institute, who has been working with the tamoxifen study since its inception, explains what's involved in conducting clinical trials. The Comprehensive Breast Center is a joint venture between the cancer institute and MaGee-Women's Hospital in Pittsburgh, which referred patients to the trial.
Pittsburgh Cancer Institute was one of 300 medical centers throughout the United States involved in the research, which included recruiting participants and following up with medical exams. Its recruitment efforts included running a national ad in Good Housekeeping magazine, running ads in local publications, contacting community organizations, and notifying physicians to refer patients. Women were asked to participate for seven years - taking pills for five years, with two more years of follow-up.
After securing 82 participants, the cancer institute's role was to make sure patients took the pills daily and conduct a medical exam every six months. Participants who lived too far to travel to Pittsburgh would see their local gynecologist for a checkup, then Connolly would follow up by calling participants. Connolly asked about the participants' general health, any health problems they had experienced and resulting treatment, and any side effects during this time. She also encouraged women to get endometrial biopsies yearly since endometrial cancer was a potential side effect.
Benefits and side effects were recorded throughout the time period, with findings reviewed every few months. After the primary study was completed and showed a reduction in breast cancer with tamoxifen, officials with the Breast and Bowel Project decided to release the information in early April. Connolly said she tried to reach all her participants before the news hit the press.
Now that information is out about the initial results, the Pittsburgh Cancer Institute will continue to follow its research group, because some participants still need to complete their five years of tamoxifen.
"We will continue to follow them until we understand what's going to happen in the long run. There is no closed date to the study," says Connolly.
The next steps on tamoxifen research include another Breast and Bowel Project study starting this fall - which points to the need to recruit more women. That's where women's health centers come in, she adds.
"Women's health centers play a vital role in encouraging women to participate in breast cancer research - that's where [the Breast and Bowel Project] was able to find 13,000 participants," Connolly says.
Both women's health centers and participants benefit from getting involved in research, Connolly maintains. Women's health centers are ultimately increasing the body of knowledge and advancing science, she says. And, by offering patients the chance to participate in research trials, women's centers are giving their patients another option in their health care needs, Connolly adds.
Participants may get free exams - which for some women is the best primary care they will receive, she says. In addition, prevention programs focus on keeping participants healthy, such as encouraging patients to do breast exams.
Women's health centers can help recruit women by presenting information about studies in newsletters, placing recruitment pamphlets in hospital waiting areas or bulletin boards, and announcing studies through their educational programs, Connolly suggests. Find out locations of the nearest participating centers for research by calling 800-4-CANCER (800-422-6237).
"Helping recruit women participants for breast cancer research is such a simple thing for women's health centers to do, and it greatly contributes to women's health," Connolly adds.
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