Study concept and design: Pisansky, Greenberg, Bruner.
Acquisition, analysis, or interpretation of data: Pisansky, Pugh, Greenberg, Pervez, Reed, Rosenthal, Mowat, Raben, Buyyounouski, Kachnic, Bruner.
Drafting of the manuscript: Pisansky, Pugh, Bruner.
Critical revision of the manuscript for important intellectual content: Pisansky, Pugh, Greenberg, Pervez, Reed, Rosenthal, Mowat, Raben, Buyyounouski, Kachnic, Bruner.
Statistical analysis: Pugh, Bruner.
Obtained funding: Bruner.
Administrative, technical, or material support: Pugh.
Study supervision: Pisansky, Pugh, Greenberg, Bruner.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Raben reported that he received consultancy and lecture payments from Bristol-Myers Squibb. Dr Buyyounouski reported that he received personal fees from Augmenix and General Electric Healthcare, and royalties from Amersys and Up-to-Date. Dr Kachnic reported that she gave expert testimony for Andrew Skinner Inc; received grants from the National Cancer Institute and lecture fees from the American Society for Radiation Oncology, American Society of Clinical Oncology, and Chartrounds TM; and earned royalties from Up-to-Date. Dr Bruner reported that she received grants from the National Cancer Institute and Eli Lilly & Co and travel support from the Community Clinical Oncology Program. No other disclosures were reported.
Funding/Support: This trial was conducted by the Radiation Therapy Oncology Group, which was supported by grant U10 CA21661 and by grant U10 CA37422 (Community Clinical Oncology Program) from the National Cancer Institute and by Eli Lilly & Co.
Role of the Sponsors: The study was approved and sponsored by the National Cancer Institute. The Radiation Therapy Oncology Group is solely responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication.
Disclaimers: The views presented herein are those solely of the Radiation Therapy Oncology Group and of the authors, who accept no liability for the consequences of any actions taken on the basis of information provided. This article’s contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
Previous Presentations: Presented in part at the Annual Meeting of the American Society of Clinical Oncology, Chicago, Illinois, May 31-June 4, 2013; and at the International Society for Quality of Life Research 20th Annual Conference, Miami, Florida, October 9-12, 2013.
Additional Contributions: Substantial contribution by nonauthors Snehal Deshmukh, MS, supporting statistician, for identifying and resolving data inconsistencies and providing data analysis; Roseann Bonanni, senior research associate, for developing report forms, Internet logistics, and data inquiries and validation; Dana Robinson, MEd, protocol associate, protocol development and regulatory compliance, for protocol development and management; and Denise Manfredi, BS, RT(T), radiotherapy dosimetry, for radiation therapy quality assurance, all of whom were compensated through the funding sources supporting this trial.