Mille Guldager Christiansen

Systematic nurse-led consultations based on electronic patient-reported outcomes for women with endometrial or ovarian cancer during chemotherapy—a feasibility study

Abstract Purpose This study aimed to investigate the feasibility of nurse-led consultations based on ePRO for women with endometrial or ovarian cancer receiving chemotherapy. Methods This was a prospective single-cohort feasibility study. The patients responded to weekly ePRO using the Elekta Kaiku platform, which was adapted to Danish. At selected time points during chemotherapy, nurses conducted nurse-led consultations replacing physicians. The primary outcome was the patient completion rate of ePRO reporting in the Elekta Kaiku platform. Secondary outcomes included assessing safety, acceptability, practicability, usability, patient satisfaction with ePRO, and patient symptom burden. Results Twenty patients were included, with a mean age of 59 years. A total of 320 ePRO reports were received, equivalent to an ePRO response of 18 times per patient during six cycles of chemotherapy. The results showed a high weekly completion rate (87%), high patient satisfaction with ePRO, and a continuous high symptom burden. Nurse-led consultations achieved a success rate of 55% in adhering to scheduled appointments. The primary contributing factors to this issue were the inadequate internal workflows and the complex symptom burden experienced by the patients. Conclusion This study indicates that weekly ePRO reporting in conjunction with nurse-led consultations may be feasible in this population. The use of ePRO revealed a high level of symptoms reported by patients throughout the treatment cycles. The results emphasize the importance of clinicians in proactively and systematically intervening at an early stage to prevent symptom escalation. However, the small sample size limits the generalizability of this study. Trial registration This study was registered at the Capital Region of Denmark (P-2021–179) and approved the 10/03/2021. ClinicalTtrials.gov ID: NTCC04945187.

SystematiC nurse-led cONsultations based oN Electronic patient-reported outcome among women with ovarian- or endometrial Cancer during chemoTherapy – protocol for the CONNECT study

A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy

Abstract Background Women with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute’s measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin. Methods A two-phase, sequential multi-methods approach was applied. In phase one, a comprehensive literature search was done to map the toxicity of the applied chemotherapeutics and phase III clinical studies. Phase two, which comprised selecting the PRO-CTCAE items, included discussions with and feedback from a patient advisory board, an additional literature search, and focus group interviews with senior oncologists and specialized oncology nurses. A national expert panel facilitated both phases in terms of carefully select items from the PRO-CTCAE library. Results Phase one identified 18 symptoms and phase two, three additional ones, leading to the inclusion of 21 PRO-CTCAE symptoms in the final PRO tool. Since PRO-CTCAE also contains one to three sub-questions on the frequency, severity, and interference with daily activities of symptoms, there were 44 potential items. Conclusions This study describes taking a multi-method approach to selecting items from the PRO-CTCAE library for use in a population of women with endometrial or ovarian cancer undergoing chemotherapy. By systematically combining diverse approaches, we carefully selected 21 clinically relevant symptoms covered by 44 items in the PRO-CTCAE library. Future studies should investigate the psychometric properties of this PRO tool for women with endometrial or ovarian cancer.