Table A1.

Selected activities of patient early engagement in research proposal development for the RadComp study.

Pre-engagement activity	Impact
Seven conference calls with individual patients and investigators	Refined research question to breast and lung cancer with focus on HRQOL and major cardiovascular events Enfranchised patients, trustworthiness of study
One focus group with patients and patient advocates	Refined HRQOL metrics and outcomes Refined short- and long-term end points Enfranchised patients, trustworthiness of study
Multi-stakeholder conference at the National Cancer Institute	Confirmed importance of HRQOL and major cardiovascular events, and NIH’s particular interest in cardiotoxicity of cancer treatments Removed registry from study design based on NCI Radiation Research Branch Chief feedback Feedback from RADCOMP providers, manufacturers, professional societies and payers
Conference calls with the Center for Medicare and Medicaid Services	CMS attended multistakeholder conference at NCI CMS stated specific attention to coverage and evidence approaches for proton therapy across malignancies
Patient engagement infrastructure: weekly calls with patient advisors	Discussed data capture and transparency; development of patient-friendly ‘give backs’; and dissemination strategies
The PATIENTS Program External Advisory Board Calls	Feedback regarding appropriate time commitment and compensation for Stakeholder Advisory Committee members

CMS: Center for Medicare and Medicaid Services; HRQOL: Health-related quality of life; NCI: National Cancer Institute.