Deborah Watkins Bruner, R.N., Ph.D., F.A.A.N., is credited as one of the key cancer researchers to usher in a paradigm shift from medicine’s traditional survival and toxicity focus as interpreted by the clinician, toward the patient-centered focus in which patient reports of their own health status are systematically collected.
As a clinical trialist, Dr. Bruner’s research concentrates on patient-reported outcomes, symptom management, and comparative effectiveness of different types of radiation treatments. She was the first and to date only nurse to lead a national clinical trials group, a leadership position long dominated by male physicians.
Active in NCI’s community oncology programs for nearly 30 years, Dr. Bruner was involved in the first studies of symptom management and quality of life. As the principal investigator for the NRG Oncology Research Base of the NCI Community Oncology Research Program (NCORP), she studies cancer treatment and symptom management endpoints in community settings. Her research team has investigated multiple factors involved in symptom science, such as optimal radiation therapy, reduction of pain from bone metastases, prevention of cognitive loss from whole-brain radiotherapy, the impact of cancer treatment on male sexual function, and evaluations of patient-reported outcomes in cancer trials. Current research efforts are looking into the role of the human microbiome in carcinogenesis and cancer treatment outcomes.
A member of the National Academy of Medicine, Dr. Bruner has won many awards for her research as well as her mentorship of nurses, physicians, and behavioral scientists. She serves on the NCI National Cancer Advisory Board. She is the Senior Vice President for Research at Emory University and holds the Robert Woodruff Chair in the School of Nursing.
May 12, 2021 By Vivian Sheidler, RN, MS
Southeast Clinical Oncology Research Consortium, Inc. NCORP
You know that pesky eligibility criteria in nearly all clinical trials that is easy to miss – performance status (PS)? Well, performance status tools have a very rich and impressive history.
The earliest PS measure was developed in 1948 by Drs. David Karnofsky, Walter Abelman, Lloyd Craver, and James Burchneal. Named the Karnofsky Performance Status (KPS), the primary purpose of the development of the scale was to allow physicians to evaluate a patient’s ability to survive chemotherapy for cancer in a more objective manner.
A little more than a decade later in 1960, Dr. Charles Zubrod, who initiated the first NCI cooperative group (“Acute Leukemia Group B”), published the Zubrod scale. This scale is the forerunner of the ECOG Performance Status, which was first published in 1982.Sometimes you may see studies us the term “Zubrod/ECOG” to describe performance status.
In addition to KPS and ECOG, there is a version for children < 16 years of age. Named after Dr. Shirley Lansky, the Lansky Play-Performance Scale is a modification of the KPS and offers an approachable method for describing functional status in children. It was derived and internally validated in children with cancer to assess response to therapies and overall status.
Finally, if you have worked in hospice and palliative care, you are familiar with the Palliative Performance Scale (PPS). The PPS, which was originally developed in Canada in 1996, is a modification of the KPS and is designed specifically for measurement of physical status in palliative and hospice care settings. It is a validated and reliable tool used to assess a patient’s functional performance and to determine progression toward end of life. PPS measures include ambulation, self-care, intake, level of consciousness, activity, and evidence of disease.
Even though each of these scales have objective criteria for the numerical assignments, there is certainly a degree of subjectivity on the part of the clinician performing the assessment. As performance status is a measure of how well a person is able to carry on ordinary daily activities, it also provides an estimate of what treatments a person may tolerate.
Karnofsky D, Burchenal J, The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod C, ed. Evaluation of Chemotherapeutic Agents. New York, NY: Columbia University Press; 1949:191–205.
Zubrod C, Schneiderman MA, Frei E, et al. Appraisal of methods for the study of chemotherapy in man: Comparative therapeutic trial of nitrogen mustard and thiophosphoramide. Journal of Chronic Diseases; 1960:11:7-33.
Lansky DA, List MA, Lansky LL, et al (1987). The measurement of performance in childhood cancer patients. Cancer 60 (7): 1651–6.
Anderson F, Downing GM, Hill J. Palliative Performance Scale (PPS):a new tool. J Palliat Care. 1996; 12(1): 5-11
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Clinical trial outcomes can help inform our understanding of cancer and improve prevention, diagnosis, treatment, and care. But this progress could not happen without the people who choose to participate in and those who connect people with trials. These individuals also work to ensure that trial access is equitable, with the goal of helping all people benefit from studies and their outcomes.
Today’s Clinical Trials are Tomorrow’s Standard of Care
Adine Usher felt a bump on her left breast. Her mammogram just 2 months earlier was negative, but she still had a sinking feeling. It was breast cancer.
At 68 years old, “all I wanted to do was whatever I could to save my life,” she said. She was working as an advocate for children with cerebral palsy, but “it’s scary being your own advocate and doing everything possible to fight for your survival.” Keenly aware of how breast cancer affects her community (African Americans have the highest mortality rate of any racial group), her first step was to find an oncologist she could trust.
Adine’s friend had been treated by Dr. Joseph Sparano at Albert Einstein Cancer Center through 20 years of late-stage cancer. Adine met with the doctor and they ended up discussing the TAILORx clinical trial, which was enrolling women with early-stage HR-positive, HER2-negative breast cancer. The trial tested whether hormone therapy used alone was as effective as hormone therapy plus chemotherapy based on a woman’s risk of recurrence.
Adine went home and thought about what participating in TAILORx could mean for other women and African Americans. “Being in a clinical trial now could benefit someone like me in the future,” she said. She joined in 2008, and in 2018, results from the trial changed treatment guidelines: 70% of women with this common type of breast cancer do not need chemotherapy after surgery.
Coordinated by a group in NCI’s National Clinical Trials Network (NCTN), “the landmark TAILORx study provided us more clarity about treatment—we’re likely overtreating some patients but undertreating some as well,” said Joseph. Adine was in a group that got chemotherapy, but even now at age 81 and 12 years cancer free, she has never second-guessed her decision. “Doctors don’t make advances or have any kind of impact without patients participating in trials. I knew a trial was important to help others.”
Breaking Old Habits—Expanding Access to Clinical Trials
“They think they’re going to be guinea pigs,” said Dr. Raymond Osarogiagbon, about how rural and minority community members may feel about being in clinical trials. He recalled conversations with one woman’s family about her potential trial participation. “Thirty people came with her, some angry, some scared and wanting to know why I wanted to experiment on their mom,” he said. After he addressed their concerns, the woman did join a trial and is thriving now, more than 10 years later. She even has family members who’ve asked about other trials.
Although clinical trials can provide vital access to treatments, there are “historical moments people recall when the research community has not served people properly, and we continue to be burdened by that,” said Raymond. In his role as director of the multidisciplinary thoracic oncology research program at Baptist Cancer Center in Memphis, TN, he focuses on connecting people diagnosed with lung cancer to a range of treatment options that are sometimes only available through trials.
As an NCI Community Oncology Research Program (NCORP) site, Baptist brings cancer prevention, diagnostics, and care to the traditionally underserved. The center is based in Tennessee but serves much of the Southeast, meaning Raymond sees patients from states with the highest numbers of lung cancer cases and deaths and “some of the worst social determinants of health: high tobacco use, poverty, and poor health care infrastructure.” These communities were left behind, he said, “so let’s stop acting surprised when disparities and mistrust emerge. What’s more important is what we’re going to do about it.”
Clinical trials help broaden access to cancer care, offering patients options like immunotherapy that did not exist 50 years ago. “That’s exciting, but none of it has any value,” said Raymond, “if it doesn’t directly benefit all populations.”
It Takes a Village—Helping the Vulnerable Navigate Cancer
They see around 12,000 patients combined a month, many underserved. It’s challenging but rewarding work for the folks at Pittsburgh’s UPMC Hillman Cancer Center and Birmingham Free Clinic. Dr. Linda Robertson (Lyn), Patricia Andres-Sanmartin (Patty), and Lilcelia Williams (CeCe) are part of a network connecting underserved patients with cancer screenings, clinical trials, and other programs to support their health journeys.
For Patty, a Spanish interpreter and patient navigator at Birmingham, language access is especially crucial. “What good is it to have the most wonderful doctor giving the best advice if you don’t understand it?” she said, adding that patients who are elderly, uninsured, immigrants, or non-English speakers can get overwhelmed by the health care system. She’s driven to help because “if we have screening programs and patients who need them but don’t connect the two, they go to waste.”
While clinical trials can be a viable treatment option, patients of color may still feel apprehensive. As a research specialist, CeCe emphasizes the protections in place for trial participants and discusses how “participation is important now and can lead to better outcomes for our children and grandchildren.” Regardless, she said, “the patient is the expert of their body. They are in control. We’re here to guide them but also support them with whatever they decide.”
Lyn, an associate director at Hillman, echoes this message of support and education. “People think being in a clinical trial means getting a placebo or going off treatment,” but that’s not the case, she said. “We’re constantly breaking down what a trial is, what types there are, and why we call them the gold standard of care” through community sessions or even games. “Many communities know us and trust us, but it takes time to achieve that.”
When asked what motivates them, each of these women lit up and said, “the patients,” who they also help with necessities like securing housing or food. Witnessing and addressing barriers to care can be frustrating, but this team remains dedicated to being there for whoever needs them.
Clinical Trials Help Build the Future of Medicine was originally published on May 3, 2021 by the National Cancer Institute.
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