Utilizing patient input in rectal cancer trial design Journal Article
| Authors: | Alvarez, J.; Zambare, W.; George, M.; Garcia, R.; Gallagher, P.; Kitchens, C.; Bercz, A.; Kim, M. J.; Romesser, P. B.; Cercek, A.; Garcia-Aguilar, J.; Sanoff, H.; George, T. J.; Hong, T. S.; Yothers, G.; Philip, P. A.; Al Baghdadi, T.; Alese, O. B.; Shergill, A.; O'Reilly, E. M.; Meyerhardt, J. A.; Horvat, N.; Dasari, A.; Hall, W. A.; Shi, Q.; Schrag, D.; Smith, J. J. |
| Article Title: | Utilizing patient input in rectal cancer trial design |
| Abstract: | Background The treatment of locally advanced rectal cancer now includes "watch-And-wait"(WW) management for patients who exhibit a clinical complete response (cCR) to total neoadjuvant therapy (TNT). We assessed patients' knowledge and preferences regarding WW with the goal of incorporating patient input into clinical trial design. Methods Rectal cancer patients in advocacy groups (COLONTOWN/Rectalburgh and Fight CRC) were surveyed regarding perceptions about treatment strategies, tolerable risks of treatment failure, and preferences on clinical trial design. Surveys were initially distributed in 2019, with the shift toward WW prompting re-survey of select questions in 2023. Results All respondents preferred enrollment in trials that incorporated patient input. Most respondents (76%) preferred treatment that incorporated chemotherapy escalation over radiation escalation. Furthermore, when presented with a hypothetical patient who developed a cCR after chemoradiation (without the option for WW), 58% of patients chose surgical treatment (with 100% risk of permanent ostomy and 80% chance of cure) over omission of surgery (with <80% chance of cure). In contrast, when the hypothetical patient developed a cCR after TNT (with an option for WW), 82% of patients opted for selective WW over surgery. Conclusions This work successfully integrated patient advocacy groups as a resource for obtaining patient input. Surveys revealed patients had a strong preference for chemotherapy escalation, for selective WW when offered, and for incorporation of input into future clinical trial design. These findings describe how well-informed patients approach complex medical decision-making and serve as a starting point for future studies seeking to incorporate patient voices. © 2025 Oxford University Press. All rights reserved. |
| Keywords: | adult; aged; middle aged; treatment failure; clinical trial; clinical trials as topic; cancer patient; neoadjuvant therapy; research design; methodology; medical decision making; pathology; health care utilization; questionnaire; patient participation; watchful waiting; patient decision making; informed consent; personal experience; decision making; rectal neoplasms; rectum cancer; rectum tumor; therapy; chemoradiotherapy; support group; patient preference; clinical trial (topic); procedures; ostomy; patient advocacy; humans; human; male; female; article; surveys and questionnaires; advocacy group; patient recruitment |
| Journal Title: | JNCI: Journal of the National Cancer Institute |
| Volume: | 117 |
| Issue: | 7 |
| ISSN: | 0027-8874 |
| Publisher: | Oxford University Press |
| Date Published: | 2025-07-01 |
| Start Page: | 1421 |
| End Page: | 1428 |
| Language: | English |
| DOI: | 10.1093/jnci/djaf074 |
| PUBMED: | 40108482 |
| PROVIDER: | scopus |
| PMCID: | PMC12229457 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed and PDF -- MSK corresponding author is J. Joshua Smith -- Source: Scopus |
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