April 12 2022
FORTE (Five- or Ten-Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps)(ClinicalTrials.gov NCT05080673)
VisionTree and NRG-CC005/FORTE
Missing data are a significant problem, particularly for quality-of-life (QOL) assessments. Unlike data for traditional endpoints, such as survival, QOL data can never be obtained retrospectively if it is not provided by the participants at the appropriate time point. This limits researchers’ ability to accurately perform QOL statistical analyses and negatively impacts the clinical relevance of this effort. Typically, QOL forms are filled out in hardcopy (paper). To provide a more convenient method of completing participant-completed questionnaires NRG Oncology is working with VisionTree Software, Inc., San Diego, CA.
VisionTree has developed a tool, VisionTree Optimal Care (VTOC), a HIPAA-secure, user friendly, web-based software system. VisionTree offers participants on this study the option of completing the baseline questionnaires from any location that has a device with Internet access, including the participant’s home, and provides reminders to participants to complete the assessments.
Although the use of the VisionTree tool is strongly preferred and encouraged, participants may complete paper questionnaires. If paper questionnaires are used, the data is manually entered into Rave by site staff.
Administration of the baseline questionnaires
All participants enrolled in CC005 who read or understand English, or Spanish must be asked to complete the Participant-Completed Questionnaires related to demographics, family history, health, diet, and lifestyle factors. The one-time baseline Participant-Completed Questionnaires will be completed and submitted within 30 days after the participant has been randomized on the study.
VTOC Information and Instructions
- VTOC Webinar Training Series (schedule and registration) and FAQs for research associates
- Protocol Section 11.2 Optional Online Completion of Participant-Completed Questionnaires
- Protocol Section 11.3 Administration of CC005 Participant-Completed Questionnaires
Questions
For data entry and submission questions contact the CC005 Data Manager, Izabela Frak, NRG Statistics and Data Management Center, at fraki@nrgoncology.org.
If you have other questions about the trial, please contact the Clinical Coordinating Department (CCD) at FORTE@nrgoncology.org or 800-477-7227.