This study developed, and established the content validity, of a conversation aid tool (CAT) for use in clinical practice with renal cell carcinoma (RCC) patients who receive a curative nephrectomy and are at high-risk of recurrence. The CAT was pilot tested in a sample of RCC patients to establish whether the CAT increases knowledge of RCC, treatment options (such as adjuvant therapy), and care options. A cross-sectional, mixed methods design was used involving initial, exploratory interviews with RCC patients, RCC specialists and a steering group. Further content validation interviews were conducted with RCC patients and specialists. A web-based survey was conducted with RCC patients (N = 60), to compare the CAT versus a standard of care (SOC) consultation comparator tool on patient knowledge. Findings from exploratory interviews were used to develop the CAT. Content validation interviews demonstrated that the CAT was well understood and relevant to RCC patients. The web-based survey demonstrated that viewing the CAT significantly improved participants knowledge of RCC, and care options, when compared to the SOC. The findings highlight that the CAT is a relevant, comprehensive and well-understood tool for use in the post-nephrectomy consultation. Use of the CAT may increase patient knowledge of RCC and care options.
Background: The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) is among the most widely-used patient-reported outcome measures (PROMs) in cancer research and practice. It was developed prior to guidance that content should be established directly from patients to confirm it measures concepts of interest and is appropriate and comprehensive for the intended population. This study evaluated the content validity of the QLQ-C30 for use with cancer patients. Methods: This study included adults undergoing cancer treatment in Europe and the USA. Patients participated in open-ended concept elicitation interviews regarding their functional health, symptoms, side effects, and impacts on health-related quality of life (HRQoL). Thematic analysis of interview transcripts was conducted, and similarities across cancer types, disease stages and countries or languages were explored. Findings: Interviews with 113 cancer patients (85 European, 28 USA) including breast, lung, prostate, colorectal, and other cancers were conducted between 2016 and 2020. Conceptual saturation was achieved. The most frequently reported concepts were included in the QLQ-C30 conceptual framework. QLQ-C30 items were widely understood across language versions and were relevant to patients across cancer types and disease stages. While several new concepts were elicited such as difficulty climbing steps or stairs, weight loss, skin problems and numbness, many were not widely experienced and/or could be considered sub-concepts of existing concepts. Interpretation: In this diverse and contemporary patient sample, QLQ-C30 items were widely understood across language versions and relevant to patients across cancer types and disease stages. Evidence of content validity is in relation to context of use; users should consider if assessment of additional concepts is warranted. The QLQ-C30 demonstrates good evidence of content validity for the assessment of functional health, symptom burden, and HRQoL in patients with localised-to-advanced cancer.Funding Information: This work was supported by the EORTC Quality of Life Group [Grant number 006-2015]. Declaration of Interests: The following authors declare no competing interests: Andrew Bottomley, Neil K Aaronson, Deborah Fitzsimmons, Mogens Groenvold, and Sally Wheelwright . Authors Colin Johnson, Krzysztof Tomaszewski, Michael Koller, Monica Pinto, Simone Oerlemans, and Heike Schmidt’s respective institutions were provided funding from the EORTC Quality of Life Group to conduct the research described in this manuscript. Authors Jane R Wells, Chelsea Finbow, Elizabeth Exall, Chloe Tolley, and Laura Grant are or were at the time of the study employees of Adelphi Values Ltd. Adelphi Values Ltd was provided a grant from the EORTC Quality of Life Group to conduct the research described in this manuscript and to develop this manuscript. Adelphi Values Ltd provides consultancy for a variety of pharmaceutical companies. Author Kim Cocks is an employee of Adelphi Values Ltd. However, the role of Principal Investigator on this study was not funded through the EORTC Quality of Life Group grant. Kim Cocks has received consulting fees from Endomag Ltd. Author Galina Velikova’s institution was provided funding from the EORTC Quality of Life Group to conduct the research described in this manuscript and other research. Galina Velikova also declares that her institution has grants/contracts with Breast Cancer Now, Pfizer, and IQVIA. Galina Velikova discloses relationships with Novartis, Eisai, Seattle Genetics, Sanofi Advisory Board, and Roche Ester Steering Committee.Ethics Approvals: Ethical approval in the US was obtained from Copernicus Independent Review Board (IRB), approval was granted before any research activities began and the IRB tracking number is: ADE1-18-151. UK: Ethical approval in the UK was obtained from the Integrated Research Application System (IRAS) and the Health Research Authority (HRA), approval was granted before any research activities began and the IRAS project ID is: 211835 and Research Ethics Committee (REC) reference is: 17/SC/0305. Italy: Ethical approval in Italy was obtained from Comitao Etico IRCCS Pascale at the Istituto Nazionale per lo Studio e la Cura dei Tumori and approval was obtained before the study began. Germany:The ethical approval was applied for at the ethics commitee of the Medical Faculty of the Martin Luther University Halle Wittenberg.The final ethical approval was received Nov. 22 2018; Identification number: 2018-143Ethical approval in Germany (site Regensburg) was obtained from Ethikkommission an der Universität Regensburg and approval was obtained before the study began. Poland: Ethical approval in Poland was obtained from the Jagiellonian University Medical College Bioethical Commission and approval was obtained before the study began. The registry number for the approval was: KBET/187/B/2017.
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