Women’s Intervention Nutrition Study (WINS)

We conducted a randomized clinical trial with 2,437 women, aged 48 to 79, from 37 clinical centers in the United States. They all received standard breast cancer management, including surgery and radiation therapy, if indicated. Patients with hormone receptor-positive disease received adjuvant tamoxifen for five years, and they could also receive chemotherapy, while patients with hormone receptor-negative disease received one of the protocol-defined chemotherapy regimens as adjuvant therapy (Chlebowski 2005; [3.1]).

After the women received standard therapy, they were randomly assigned in a 40-to-60 ratio to a dietary change group, which targeted dietary fat intake reduction, or a control group, which focused only on nutritional adequacy. The women were given a fat-gram intake goal and were instructed how to keep score daily.

The intervention was surprisingly effective in changing dietary behavior. In terms of the percentage of calories coming from fat, the women went from 29 percent at baseline, which was the same in both groups, to about 20 percent at one year, which was maintained. In terms of fat grams, they went from about 57 fat grams per day at baseline to around 31 fat grams per day.

Additionally, women in the intervention group lost about four pounds. So there was a four-pound difference, which wasn’t much, but it was three standard deviations, suggesting that dietary change had occurred (Chlebowski 2005).

Our primary study endpoint was relapse-free survival, which included all breast cancer recurrence sites, including contralateral breast cancer. We found the dietary intervention group had a longer relapse-free survival than the control population — 12.4 percent of the patients in the control group had a relapse compared to 9.8 percent in the dietary intervention group. This was 2.6 percent absolute difference at five years, or a 21 percent reduction in the risk of recurrence (Chlebowski 2005).

— Rowan T Chlebowski, MD, PhD

Implications of the results from WINS for clinical practice

We recognize the need for further follow-up, a peer-reviewed publication and probably a confirmatory study. Having said that, the diet was associated with nutritional adequacy, can be recommended for other health reasons and would have, really, no appreciable side effects. The American Cancer Society, for instance, right now offers recommendations for dietary changes after cancer diagnosis: they’re all based on inference. We have a signal that there might be a cancer benefit also. I believe we wouldn’t tell every patient that she has to make the dietary changes. If somebody wanted to do something, you’d say, “Here’s something that you could do. It may inf luence your breast cancer, but it has these other potential benefits.”

— Rowan T Chlebowski, MD, PhD

Women want to be in charge, and our job is to be their advocates and to empower them. Our community is well informed, and as soon as patients hear about something new, they want to know how it relates to them. One example is the new data on the impact of a low-fat diet on the risk of breast cancer recurrence. When this information was released, our patients were just waiting to see how we would respond. We are developing a program where patients will be provided a low-fat diet sample. We hope they will embrace this and change their diets accordingly.

— Nancy Sokolowski, RNC, OCN

Evaluating cancer patients’ satisfaction with healthcare

More and more major healthcare systems are conducting patient satisfaction surveys, because they consider doing so one of the primary indicators of a quality care institution. Patients, as you know, are only too willing to speak up if someone asks them.

When one starts to tease out what makes patients comfortable and satisfied with their care, one discovers that receiving the very best care according to the latest protocols matters. Patients are more inclined to rely on the healthcare team to help them make decisions about the newest chemotherapeutic agents. What they’re left to examine and, I believe, what they feel they have some control over is the nature of their interaction with the professionals, setting aside decisions about care. So they look very carefully at whether the individuals providing that care actually see them as persons who have feelings and concerns, not just as disease entities, and whether they are willing not only to listen, but also to say and do the right thing.

— Karen J Stanley, RN, MSN, AOCN, FAAN

Oral versus parenteral treatment

In the healthcare profession, we probably spend a lot of time assuming things, and we don’t really know whether a patient would prefer a pill to an injection or other method of parenteral administration. However, it occurs to me that if a patient receives a parenterally administered therapy, he or she is going to have an interaction with the healthcare provider. We do know, from those patients who have finished their course of care, that it’s terribly frightening to be cut loose from the healthcare team, because there’s nobody watching anymore, nobody checking to see if the disease is going to return. Patients have told us repeatedly that it is a frightening time, so it’s almost as though the visit to the office is for support as well as treatment.

As we extrapolate into the future a bit — let’s say five years from now — and look at reimbursement for cancer services in the outpatient setting, and consider the costs of administering an oral agent versus a parenteral agent, all things being equal, my belief is that over a period of time, oral agents may be reimbursed more fully than parenteral agents because they would cost Medicare less money. If indeed that scenario proves to be true, then we need to be considerate about meeting all of the needs of those patients who are receiving parenteral treatment.

The administration of an oral agent removes the physician somewhat from the patient. In community practices, I believe the nature of the relationship between oncology healthcare teams and patients is a bit different than in an academic setting. I wouldn’t go so far as to say that the care is more personal, because I don’t have evidence for that. However, my bias is that it may be true, because it’s easier to develop a relationship with those for whom you care in a community setting. In an academic setting, the oncologist is a little more removed because there are likely to be multiple physicians involved in caring for the patient, so no one physician has as close a relationship with the patient as might be true for the community oncologist.

— Karen J Stanley, RN, MSN, AOCN, FAAN