FIRE Project Shows Walking Program Decreases Fatigue in Breast Cancer Patients

BALTIMORE—What is safe, efficacious, and cost-effective, not swallowed or taken intravenously, and improves a breast cancer patient’s quality of life? Exercise, according to a group of researchers who conducted a multi-institutional, prospective, randomized controlled trial examining the effects of a supervised walking regimen on breast cancer patients.

The results showed that breast cancer patients who take part in a regular walking program have lower levels of fatigue, increased physical performance, increased functional capacity, and decreased psychological stress.

Lead investigator Victoria Mock, DNSc, RN, AOCN, presented the results at a symposium on the FIRE (Fatigue Initiative Through Research and Education) Project at the Oncology Nursing Society’s 26th Annual Congress in San Diego.

Dr. Mock is director of nursing research, Johns Hopkins Comprehensive Cancer Center; associate professor, Johns Hopkins University; and American Cancer Society Mid-Atlantic Division Professor of Oncology Nursing.

Dr. Mock began her research into the relationship between exercise and symptom management in 1994. She began with a pilot project of 14 breast cancer patients undergoing chemotherapy randomized to usual care or a rehabilitation exercise program and support group. The pilot study (Oncology Nursing Forum 21:5, 1994) found decreased fatigue in the exercise group.

She next studied 50 breast cancer patients receiving radiation therapy after breast-conserving surgery. The women were randomized to an exercise program or usual care, and, again, the results showed a decrease in fatigue in the exercise group (

Oncology Nursing Forum

24:6, 1997).

FIRE Project Funding

The exercise intervention trial described by Dr. Victoria Mock at the ONS Annual Congress was funded by the ONS Foundation and Ortho Biotech Products, LP as part of the Fatigue Initiative Through Research and Education (FIRE) Project.

Dr. Mock was the recipient of the largest competitive grant ever given by the ONS Foundation.

This year, Dr. Mock received a National Institutes of Health RO1 award, funded jointly by the National Cancer Institute and the National Institute of Nursing Research, to continue her research in a new study titled "Mitigating Cancer-Related Fatigue by Exercise," which will extend the investigation to other cancer populations.

Next came a pilot study through the FIRE Project, which established a network of fatigue researchers and tested the methods used in the larger trial reported at the ONS congress (Cancer Practice 9:3, 2001).

The Main Lesson

Dr. Mock said that the main lesson of her research is that recommendations of rest for cancer patients undergoing treatment are not sufficient in themselves to prevent fatigue and other cancer-related and treatment-related symptoms.

"When patients are told to rest, they tend to decrease their usual activity and consequently may develop more symptoms, including fatigue, over the course of their treatment. Through increasing their activity instead of decreasing it, we have been able to demonstrate a reduction in the symptoms that breast cancer patients experience during treatment," Dr. Mock said.

The current clinical trial, conducted at five eastern United States cancer centers, looked at a total of 111 women, ages 30 to 70, who took part in the walking regimen study. The vast majority, 97%, had stage I or II breast cancer, and 3% had stage III disease. Women with bone metastases were not admitted to the study.

The women were randomized to a usual treatment group or to a group that took part in the walking exercise. The intervention, a progressive program of moderate, brisk walking, was developed with the aid of an exercise physiologist and was individualized based on a participant’s age, current and previous activity, and type of cancer treatment (radiotherapy or chemotherapy).

Trained study staff taught the walking exercise intervention, which consisted of 20 to 30 minutes of walking 5 to 6 days a week, preceded by a 5-minute warm up and followed by a 5-minute cool down. The women were asked to engage in a level of exercise that increased their heart rate to between 60% and 80% of their maximum heart rate.

The regimen started concurrently with adjuvant chemotherapy or radiation therapy and continued through the duration of the initial adjuvant treatment—6 weeks for radiation therapy, 4 to 6 months for chemotherapy.

Monitoring

The staff monitored the women for safety, provided encouragement, and increased the exercise prescription or made adjustments as needed. Women were monitored by phone, at scheduled clinic appointments, and via diaries in which they recorded pre- and post-walking heart rates, total time walked, and level of perceived exertion. (The women in the nonwalking groups were also asked to keep an activity diary.)

Those in the exercise group were given a booklet with information about safety, including instructions to carry ID cards and money when they went walking. They were instructed to wear appropriate footwear, to drink plenty of water before walking, and to exercise with care on hot or cold days.

They were also told not to walk when they were nauseous or had fever or other symptoms, and to report abnormal responses to exercise such as extreme tachycardia, shortness of breath, or chest pain. (None of these symptoms were actually experienced during the study, the researchers reported.)

The outcomes measured included fatigue; physical functioning; sleep and mood using a variety of assessment scales and questionnaires; a 12-minute walking test; and a daily fatigue rating scale.

The symptom assessment scales that were employed consistently gave the same results. The findings suggested that a home-based walking exercise program during 6 weeks of radiotherapy and 4 to 6 months of chemotherapy can decrease fatigue, sleep disorder, and mood disturbance during adjuvant therapy for breast cancer.

In addition, women who exercised had a significantly higher level of sleep quality. Lower levels of sleep quality correlated with higher levels of fatigue and mood disturbance.

Other findings were that women about to initiate chemotherapy had a much higher level of mood disturbance than those beginning radiation therapy.

Dr. Mock cautioned that since the study was conducted on breast cancer patients, it is not possible to say how safe and effective such a program would be for patients with other cancer diagnoses.

"I think we have reason to believe that it may be effective in some other patients with solid tumors, but I would be hesitant to recommend exercise for any diagnosed leukemia patient, a patient with a brain tumor, or other patients who have high levels of disease. So we need to do a lot more work with this intervention with other cancer diagnoses."

Site investigators were Ruth McCorkle, PhD, Yale University; Mary Ropka, PhD, University of Virginia; Mary Pickett, PhD, University of Pennsylvania; and Barbara Poniatowski, MS, Greater Baltimore Medical Center.

A Paradigm Shift

Dr. McCorkle called the recommendation for exercise rather than rest "a paradigm shift in oncology care." If the evidence continues to mount that exercise has beneficial effects on cancer patients, she said, "exercise prescriptions may become part of standard care, with insurers and managed care companies providing coverage."

Dr. McCorkle, professor and director of the Center for Excellence in Chronic Illness Care, Yale University School of Nursing, called for more specific research-based protocols for recommending exercise to cancer patients.

"The effect of exercise on different cancers also needs to be investigated, plus the timing of exercise in the course of treatment," she said.

Other areas in need of study, she said, are the effects of exercise on immune response, survival, hospital readmissions, cost of care, menopausal symptoms, loss of bone density, and changes in body image. She noted that it is also important to find strategies to help patients adhere to their exercise program.