Patient Related Outcome Measures (May 2023)

Patient-Reported Outcomes in Ovarian Cancer: Facilitating and Enhancing the Reporting of Symptoms, Adverse Events, and Subjective Benefit of Treatment in Clinical Trials and Clinical Practice

  • Campbell R,
  • King MT,
  • Stockler MR,
  • Lee YC,
  • Roncolato FT,
  • Friedlander ML

Journal volume & issue
Vol. Volume 14
pp. 111 – 126

Abstract

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Rachel Campbell,1 Madeleine T King,1 Martin R Stockler,2 Yeh Chen Lee,2– 4 Felicia T Roncolato,2,5 Michael L Friedlander3,4 1University of Sydney, Faculty of Science, School of Psychology, Sydney, NSW, Australia; 2University of Sydney, NHMRC Clinical Trials Centre, Sydney, NSW, Australia; 3School of Clinical Medicine, Faculty of Medicine and Health, University of New South Wales, Sydney, NSW, Australia; 4Department of Medical Oncology, Prince of Wales and Royal Hospital for Women, Sydney, NSW, Australia; 5MacArthur Cancer Therapy Centre, Campbelltown Hospital, Sydney, NSW, AustraliaCorrespondence: Rachel Campbell, University of Sydney, Room 325, Brennan-Maccallum Building, Sydney, NSW, 2006, Australia, Tel +61 2 8627 7631, Email [email protected]: Patient-reported outcomes (PROs) provide a valid, standardized way of assessing symptoms, adverse events and the subjective benefit of treatment from the patient’s perspective. Assessment of PROs is critical in ovarian cancer due to the high morbidity of the disease and its treatments. Several well-validated PRO measures are available to assess PROs in ovarian cancer. Their inclusion in clinical trials can provide evidence on the benefits and harms of new treatments based on patients’ experiences to guide improvements in clinical practice and health policy. Aggregate PRO data collected in clinical trials can be used to inform patients about likely treatment impacts and assist them to make informed treatment decisions. In clinical practice, PRO assessments can facilitate monitoring of a patient’s symptoms throughout treatment and follow-up to guide their clinical management; in this context, an individual patient’s responses can facilitate communication with their treating clinician about troublesome symptoms and their impact on their quality of life. This literature review aimed to provide clinicians and researchers with a better understanding of why and how PROs can be incorporated into ovarian cancer clinical trials and routine clinical practice. We discuss the importance of assessing PROs throughout the ovarian cancer disease and treatment trajectory in both clinical trials and clinical practice, and provide examples from existing literature to illustrate the uses of PROs as the goals of treatment change in each setting.Keywords: ovarian cancer, patient-reported outcomes, clinical trials, clinical practice

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