Radiation Clinical Trials Must Evolve to Include Patient-Reported Outcomes

October 14, 2020

Prostate cancer is one of the most common cancers treated with radiotherapy (RT). Conventional RT (CRT) for low-risk patients usually involves 40–45 treatments given over eight or nine weeks. Several studies suggest (http://www.doi.org/10.1200/JCO.2016.67.0448) that hypofractionated RT (HRT)—fewer treatments but with a higher dose per treatment—may produce a similar survival benefit. When two treatments have similar survival outcomes, the decision process looks at symptom profiles, quality of life (QOL), and cost.

Deborah Watkins Bruner, RN, PhD, FAAN, is the senior vice president of research and professor in the school of nursing and department of radiation oncology at Emory University in Atlanta, GA, and a presenter at the 2020 ONS Bridge™ virtual conference.
Deborah Watkins Bruner, RN, PhD, FAAN, is the senior vice president of research and professor in the school of nursing and department of radiation oncology at Emory University in Atlanta, GA, and a presenter at the 2020 ONS Bridge™ virtual conference.

One clinical trial exemplifies the importance of including patient reported outcomes (PROs) as well as survival. Lee et al. randomized (http://www.doi.org/10.1200/JCO.2016.67.0448) 1,092 men to receive either 73.8 Gy of CRT in 41 fractions over 8.2 weeks or 70 Gy of HRT in 28 fractions over 5.6 weeks. In men with low-risk prostate cancer, HRT was similar to CRT in terms of five-year disease-free survival and prostate cancer-specific symptoms related to bowel, bladder, and sexual function; general health-related QOL; and measures of anxiety and depression. However, investigators found an increase in late gastrointestinal and genitourinary clinician-reported adverse events in the patients treated with HRT.

The trial included the secondary endpoints of symptoms and QOL, and investigators looked at both survival and PROs, which provided evidence to affirm (http://www.doi.org/10.1001/jamaoncol.2018.6752) HRT as a practice standard for men with low-risk prostate cancer.

It also exemplified some of the recent progress seen in RT clinical trials, particularly the comprehensive assessment of patient experience with validated PRO measures. Researchers must look beyond biologic endpoints like tumor size or years of survival and include the patient perspective about the quality of their survival. We have made great strides in recent years, but still have far to go. Sadly, not all clinical trials assess outcomes from the patient perspective.

Nurses at all levels of practice are critical to improving the process. Nurse scientists can design trials that consistently incorporate PROs, whereas clinical nurses can critically review literature and identify deficits in trials that lack patient perspectives, especially when sharing information with patients. All nurses can:

Advise the patient advocacy groups they work with to support including the patient perspective in clinical research.

Advocate in our professional societies for PROs to become standard measures of adverse event reporting to complement standard clinical reporting.


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