@article{c7478af79a964c3aa3a93eb74390ed53,
title = "Patient familiarity with, understanding of, and preferences for clinical trial endpoints and terminology",
abstract = "Background: Although there is increased attention to designing and explaining clinical trials in ways that are clinically meaningful for patients, there is limited information on patient preferences, understanding, and perceptions of this content. Methods: Maximum difference scaling (MaxDiff) methodology was used to develop a survey for assessing patients' understanding of 19 clinical terms and perceived importance of 9 endpoint surrogate phrases used in clinical trials and consent forms. The survey was administered electronically to individuals with metastatic breast cancer affiliated with the Metastatic Breast Cancer Alliance. Analyses were performed using Bayesian P values with statistical software. Results: Among 503 respondents, 77% had a college degree, 70% were diagnosed with metastatic disease ≥2 years before survey completion, and 77% had received ≥2 lines of systemic therapy. Less than 35% of respondents reported understanding “fairly well” the terms symptomatic progression, duration of disease control, time to treatment cessation, and endpoints. Income level and time since onset of metastatic disease correlated with comprehension. Patients who had received ≥6 lines of therapy perceived that time until serious side effects (P <.001) and time on therapy (P <.001) were more important compared with those who had received only 1 line of therapy. Positively phrased parameters were associated with increased perceived importance. Conclusions: Even among educated, heavily pretreated patients, many commonly used clinical research terms are poorly understood. Comprehension and the perceived importance of trial endpoints vary over the course of disease. These observations may inform the design, discussion, and reporting of clinical trials.",
keywords = "breast cancer, clinical trial, comprehension, endpoints, outcomes, patient-reported outcomes, quality of life",
author = "{von Itzstein}, {Mitchell S.} and Elda Railey and Smith, {Mary L.} and White, {Carol B.} and Sledge, {George W.} and Howell, {John R.} and Wendy Lawton and Marinucci, {Donna M.} and Nisha Unni and Gerber, {David E.}",
note = "Funding Information: Elda Railey reports grants from Celgene, the Eastern Cooperative Oncology Group‐American College of Radiology Imaging (ECOG‐ACRIN) Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. Mary L. Smith reports grants from the American Society of Clinical Oncology (ASCO) Conquer Cancer program, Celgene, the ECOG‐ACRIN Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. Carol B. White reports personal fees and other support to her firm (CBWhite) from the Research Advocacy Network and other support to CBWhite from Genentech, the Metastatic Breast Cancer Network, and Genentech during the conduct of the study; personal fees from the Research Advocacy Network outside the submitted work; and other support from the ASCO Conquer Cancer program, Celgene, the ECOG‐ACRIN Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. The remaining authors made no disclosures conflicts of interest. Funding Information: This work was funded in part by the Metastatic Breast Cancer Network and Novartis (grant NCG31570 to the Research Advocacy Network), by Genentech (grant G‐51105 to the Research Advocacy Network), and by a National Cancer Institute Midcareer Investigator Award in Patient‐Oriented Research (K24 CA201543‐01 to David E. Gerber). Funding Information: This work was funded in part by the Metastatic Breast Cancer Network and Novartis (grant NCG31570 to the Research Advocacy Network), by Genentech (grant G-51105 to the Research Advocacy Network), and by a National Cancer Institute Midcareer Investigator Award in Patient-Oriented Research (K24 CA201543-01 to David E. Gerber). Elda Railey reports grants from Celgene, the Eastern Cooperative Oncology Group-American College of Radiology Imaging (ECOG-ACRIN) Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. Mary L. Smith reports grants from the American Society of Clinical Oncology (ASCO) Conquer Cancer program, Celgene, the ECOG-ACRIN Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. Carol B. White reports personal fees and other support to her firm (CBWhite) from the Research Advocacy Network and other support to CBWhite from Genentech, the Metastatic Breast Cancer Network, and Genentech during the conduct of the study; personal fees from the Research Advocacy Network outside the submitted work; and other support from the ASCO Conquer Cancer program, Celgene, the ECOG-ACRIN Medical Research Foundation, Foundation Medicine Inc, Genentech, Genomic Health Inc, the Metastatic Breast Cancer Network, Novartis, and Seattle Genetics, outside the submitted work. The remaining authors made no disclosures conflicts of interest. Publisher Copyright: {\textcopyright} 2020 American Cancer Society",
year = "2020",
month = apr,
day = "15",
doi = "10.1002/cncr.32730",
language = "English (US)",
volume = "126",
pages = "1605--1613",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "8",
}