Analyzing outcomes
Studying patients' quality of life after cancer therapies
By Richard Saltus
Stephanie Lee, MD, MPH, finds most patients' lives return to normal following bone marrow transplants.
It seems to be a no-brainer. Surely a high-tech "minimally invasive" operation for colon cancer, using long-handled tweezer-like instruments inserted through small holes in the abdomen, would be easier on patients than the traditional method requiring a large incision in the belly for the surgeon's hands.
Less pain, smaller doses of painkillers, a shorter hospital stay: that's the rationale for the new and popular "laparoscopic-assisted colectomy" that many surgeons are using to cut out colon cancer. But no one had put these assumptions to a rigorous test.
Now Jane Weeks, MD, MSc, head of Dana-Farber's Center for Outcomes and Policy Research, has published a "quality-of-life" study comparing the two methods — and the results are surprising. Patients who underwent the less-invasive procedure had only slightly less discomfort and shorter hospital stays than those undergoing traditional "open" surgery, Weeks found. The supposed advantage of the minimal procedure was not statistically significant. There are also some doubts about whether it is as effective for cancer removal as the standard surgery.
"Many surgeons who do this procedure are distressed by what we found," says Weeks, whose paper, co-authored by Mayo Clinic researchers, was published in the Jan. 16 issue of the Journal of the American Medical Association. "It was a big surprise, and it is a real threat to this cool procedure they believe in." The researchers concluded that the minimally invasive operation shouldn't be offered except in clinical trials until it is shown to be equally effective at eliminating the cancer.
The procedure "is used routinely throughout eastern Massachussetts, but the new findings clearly dampen enthusiasm for it," comments Robert Mayer, MD, director of the Center for Gastrointestinal Oncology at DFCI. "In my judgment, it is an experimental approach until it's proven as effective in eliminating cancer as traditional surgery," he adds.
The recent surge in quality-of-life research "is a testament to the successes of treating cancer."
— Julia Rowland, director of the Office of Cancer Survivorship, National Cancer Institute
For Weeks, unexpected results like these aren't troubling — in fact, they're gratifying. "People think they know the answers to these questions, and over and over again they've been surprised, which suggests that the research is worth doing," she says.
The center Weeks heads includes Joanne Wolfe, MD, MPH; Stephanie Lee, MD, MPH; Steven Joffe MD, MPH; and Craig Earle, MD.
Outcomes research can mean many things, but generally it evaluates variations in medical care and differences in people's access to health care. It scrutinizes not only the effectiveness of treatments but also their impact on patients' quality of life: their physical, psychological, and even financial well-being.
As a cancer specialist, Weeks sees her mission as assessing "the whole process of decision-making, including how to make sure the patient's wishes are known and honored and that there is respect for the patient as a partner in cancer care. The questions I ask [in outcomes research] are derived from my experience with patients," says Weeks, who trained in medical oncology at Dana-Farber from 1987 to 1991, and continues to hold clinical appointments at DFCI and Brigham and Women's Hospital. When her medical colleagues' assumptions about treatments are challenged or overturned, they may not be pleased, but Weeks says she doesn't mind the heat. "I like being provocative," she admits. "I think it should be our goal to change patient care to make it better."
Robert Mayer, MD
Until recently, cancer specialists were focused on trying to cure or control disease, and the long-term consequences of treatment got little attention. Today, however, many clinical trials in cancer now include a quality-of-life component, like Weeks' study that evaluated the minimally invasive colon cancer operation.
The recent surge in quality-of-life research "is a testament to the successes of treating cancer," says Julia Rowland, director of the Office of Cancer Survivorship at the National Cancer Institute, adding that about 9 million Americans are now living after cancer treatment.
Sometimes, an outcomes-related finding emerges from a study collecting data for other questions. That was the origin of a report in 1999 in which Weeks, along with Harold Burstein, MD, PhD, of Adult Oncology, found that women who turned to alternative medicine after a new diagnosis of breast cancer tended to be more fearful, depressed, and less satisfied with their sexual lives. She took pains to say this link was only an association, not necessarily cause and effect, but the report stirred controversy and a backlash.
"It was seen by some as an attack on the complementary-therapy community," she says. It wasn't: "We hope our findings encourage doctors to open a dialogue with patients about the use of complementary therapies, and to be more attuned to the distress it may signal," Weeks says. "This gives us a new opportunity to be sure that all patients receive the most effective therapies available to help them cope with the stresses of serious medical illness."
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