OBJECTIVES: Regulatory agencies are increasingly recognizing improvement in patient reported outcomes (PROs) assessing quality of life, physical functioning, and tumor-related symptoms as direct evidence of clinical benefit when evaluating cancer therapeutics. This study examines breast cancer patient perspectives on the benefit of reporting symptoms, type of symptoms to report, and the importance of doctor review of PRO data.

METHODS: 52 participants aged 34-79 (M= 58.33, SD= 10.28) with a self-reported history of breast cancer diagnosis, completed an online survey to assess preferences and opinions regarding reporting of symptoms during a clinical trial. Responses were provided in a multiple-choice format. Demographic information were also recorded.

RESULTS: When asked about the benefit of reporting symptom information on a daily basis, 75.5% of participants indicated there is “very much (49.1%) or “quite a bit” (26.4%) of benefit. The majority of participants indicated that the most important information they can provide to researchers includes physical symptoms (64.2%), although 20.8% chose ability to perform every day activities, 9.4% chose impact on personal and social relationships, 3.8% chose mood, and 1.9% chose self-care as most important. Finally, 98% of participants reported that it is “very important” (68%) or “important” (30%) that doctors review this information.

CONCLUSIONS: The majority of participants with a history of breast cancer feel that it is beneficial to provide daily symptom information to their study doctors and nearly all participants indicated that it is important their study doctors review such symptom information. Changes in physical symptoms were considered the most important type of information to provide to study doctors, however ability to perform everyday activities (such as household chores, hobbies, and leisure activities) was also frequently identified. Breast cancer patients’ perspectives on symptom reporting aligns with growing regulatory emphasis on PROs in oncology studies.