Understanding patient preferences regarding toxicities is crucial to the enhancement of shared decision-making, according to data presented at the Society of Gynecologic Oncology's (SGO) 2017 Annual Meeting on Women's Cancer (Abstract 47).
“Patients are No. 1,” David E. Cohn, MD, Director of the Division of Gynecologic Oncology at the Ohio State University College of Medicine, told Oncology Times. “Understanding what patients' preferences are at baseline will help ensure that we are addressing decisions in a shared fashion.”
Lari Wenzel, PhD, is Principal Investigator of the study, and Dana B. Mukamel, PhD, Director of the iTEQC Research Program at the University of California, Irvine, devised the study design and patient decision aid.
Decision Tool Design
Prior to the initiation of the randomized study, Cohn and his team set out to design the decision aid that would be utilized.
“We initially convened focus groups that involved patients to ask them what their interests were about shared decision-making with ovarian cancer,” noted Cohn. “Additionally, we involved the physician focus groups to determine their interest in having a decision aid for this purpose.
“The decision aid was then populated with information regarding side effects of treatment and survival of treatment that was calculated from the randomized controlled trial GOG 252, and when that wasn't available, we used an Expert Consensus Panel,” he continued. The team then put together the technology to create the decision tool, which was either web-based or IOS-based for the iPad.
The Patient Centered Outcome Aid (PCOA), supplements, but does not replace, counseling, investigators noted during the SGO presentation. According to the research team, the tool is utilized to educate and facilitate knowledge and understanding of the best available evidence of the risks and benefits across all available options, while incorporating patient values.
The randomized control trial, “Ovarian Cancer Patient-Centered Decision Aid,” included newly diagnosed ovarian cancer patients facing a decision on the route of administration of chemotherapy of either intravenous (IV) or intraperitoneal (IP)/IV,” according to researchers.
Patients were randomized into one of two cohorts, either utilizing standard-of-care discussions of IV versus IP/IV therapy or the computer-based PCOA. Standard-of-care discussions involve the typical conversation with the provider about treatment options, which may or may not involve shared decision-making based on the individual provider, noted Cohn.
The PCOA outlines the major side effects patients are likely to experience during chemotherapy: nausea and vomiting, neuropathy, fatigue, and abdominal pain. It includes three severity levels for each: mild, moderate, and severe.
Investigators then had patients rank the four side effects and the three possible severity levels on a visual analog scale from 1 (preferred) to 100 (not preferred). “We sought to determine what the patients' preferences were regarding possible side effects,” said Cohn.
“We then assessed the participants with general quality of life instruments, as well as those related to fatigue and abdominal pain.” The instruments utilized, included FACT (Functional Assessment of Cancer Therapy)-O-TOI (general), FACT-fatigue, and FACT/GOG-AD (abdominal pain).
PCOA and quality-of-life surveys were administered to candidates for IV or IP/IV chemotherapy at the first visit after optimal cytoreduction. The average age of participants was 58 years, and 93 percent were Caucasian, according to researchers. Eighty percent of patients were deemed “healthy” and less at risk for toxicity.
The data presented at SGO were the results of the baseline survey completed by 123 women with ovarian cancer.
In general, patients who participated in the PCOA were most concerned about nausea, followed by pain, and then sensory neuropathy. They were least concerned by fatigue. These concerns varied across individuals.
“When determining baseline quality of life, we found that overall this patient population had decent functional and physical well-being, and relatively modest fatigue scores and low abdominal discomfort at baseline,” Cohn noted.
Researchers reported a mean TOI score of 66 (SD=17), a fatigue score of 33 (SD=9), and an abdominal discomfort of 11 (SD=4).
Cohn acknowledges the biggest limitation of the study was the small sample size. Additionally, a second limitation was that a small subset of patients had already received neoadjuvant chemotherapy IV treatment. “As a result, this has the potential to bias the results because those patients already know their preferences from experiences whereas the chemotherapy-naïve patients may be a very different population,” explained Cohn.
This study sheds light on the importance of patients in the decision-making process and the need for physicians to understand a patient's expectations.
“We, as physicians and providers, might, for example, believe that patients are most interested in avoiding neuropathy, but it may be that patients are more concerned about avoiding nausea,” noted Cohn. “This is one very important implication to consider; knowing what our patients' preferences are will help in the process of shared decision-making.”
Data collection beyond baseline is ongoing to establish the relationship between PCOA and decision-making satisfaction. “While we are still collecting data as patients go through the remainder of the study, our hope is that we will find that the decision aid improved satisfaction with decision-making,” Cohn concluded. “However, even if it doesn't show that, it still sets up the opportunity to design decision aides for other populations of women with ovarian cancer because, as hard as the decision is for IV or IP chemotherapy, I believe employing shared decision-making and understanding patient preferences is critical to effective treatment in the recurrence setting, where patients are not curable.”
“When cancer patients face difficult treatment decisions, shared decision-making can offer important advantages. These include education about treatment options, their potential consequences, and potential risks and benefits,” Wenzel added. “We hypothesize that our shared decision-making model facilitated an understanding of preferences in the treatment choice decision, vis a vis potential side effects and their severity.
“With the opportunity to participate in a shared decision-making process will believe that patients will feel ownership of the decision, will be more satisfied with the decision, and will likely perceive themselves to have better treatment outcomes,” she concluded.
Catlin Nalley is associate editor.