Editor: Deborah Sesok-Pizzini, MD, MBA, adjunct professor, Department of Clinical Pathology and Laboratory Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Study of the psychosocial impact of a multicancer early detection test
July 2025—A large number of cancers remain undetected until later stages, including lung, colorectal, cervical, ovarian, pancreatic, and prostate cancers. The U.S. Preventive Services Task Force recommends screening based on age and other risk factors. It is estimated that more than 4 million cancers have been avoided due to early screening methods. Efforts are being made to develop cancer-screening tests that are easier to perform and less invasive and that detect multiple types of cancer, with the intent of reducing cancer-related morbidity and mortality. Multicancer early detection (MCED) assays depend on circulating cell-free DNA to detect a shared single cancer signal. The large prospective cohort study PathFinder assessed the extent of diagnostic testing performed for cancer detection and the time to diagnostic resolution after a cancer signal-detected (CSD) result from an MCED test. The MCED testing, which was performed on a healthy outpatient ambulatory population, detected several types of cancer for which there are no standard screening tests, such as liver, ovarian, and pancreatic cancers. However, there is concern that positive findings from this type of MCED cancer screening can have adverse psychosocial effects on recipients. Furthermore, feelings of anxiety, distress, or worry may further reduce adherence to recommended screenings. Conversely, a negative MCED test result may lead to positive psychological feelings and reassurance. The authors of the study featured herein expanded on previous research that showed that the negative psychological effects following an indeterminate or false-positive result are only transient and return to baseline levels months after cancer screening. For this study, the authors, several of whom were involved in the earlier phase of PathFinder, evaluated patient-reported outcomes (PROs) in PathFinder participants who did and did not have CSD after a follow-up 12-month period. The PathFinder study had hypothesized that MCED testing would be associated with negligible short-term effects on PROs. The study had been conducted on healthy ambulatory outpatients at seven U.S. health networks, including hospitals, academic medical centers, and integrated health systems. The participants were 50 years or older and had no clinical suspicion of cancer. They did or did not have additional cancer risk factors, such as smoking, genetics, or prior cancer diagnosis. Between Dec. 12, 2019 and Dec. 4, 2020, 6,662 participants were enrolled. Of that group, 6,621 had MCED test results that could be analyzed at the end of the 12-month study. Ninety-two of the evaluable participants had CSD and 6,529 had no CSD (NCSD). The majority of participants were women and white (63.5 and 91.7 percent, respectively). The 12-month PathFinder study reported herein assessed PROs and perceptions of MCED testing, including the effects of MCED test result disclosure, general anxiety symptoms, health-related quality of life, and satisfaction with the MCED test. The PRO measurements included an adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) for distress, uncertainty, and positive anxiety symptoms and Short Form 12-Item Health Survey (SF-12v2) for health-related quality of life. Intentions toward adherence to guideline-recommended screening were also assessed. Among participants who completed the MICRA at results disclosure, the mean total score was 28.4 for the patients with a CSD result and 8.8 for those with an NCSD result. As expected, mean general anxiety scores increased in true-positive and false-positive groups at results disclosure. The PRO Measurement Information System (PROMIS) anxiety true-positive group baseline score of 46.2 increased to 48.7, and the score in the false-positive group increased from 47.3 to 49.7. However, the mean scores in both groups returned toward baseline by the end of the study. The mean SF-12v2 mental component summary and scale scores were within the average range for the general population at all time points. The majority (97.1 percent) of patients responded that they were satisfied, very satisfied, or extremely satisfied with the MCED test. Moreover, most (95.6 percent) indicated they were likely or very likely to adhere to health care providers’ future cancer screening recommendations at the end of the study. The authors demonstrated that the patient-reported effects associated with a CSD result from MCED testing were small and returned to baseline within 12 months with or without a cancer diagnosis. They noted that the results from the PathFinder study show the potential early benefit of cancer detection, with minimal patient psychological impact with MCED testing.
Nadauld L, McDonnell CH, Dilaveri CA, et al. Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre cohort study. Lancet Oncol. 2025; 26:165–174.
Correspondence: Dr. Donald L. Patrick at donald@uw.edu
Use of a patient-navigation program to improve colonoscopy completion after an abnormal stool test result
Stool testing, such as fecal immunochemical testing, is a cost-effective strategy for colorectal cancer screening. Improving such screening could reduce mortality from colorectal cancer by more than 50 percent, but only if patients with abnormal stool test results undergo follow-up colonoscopies. The U.S. Multi-Society Task Force on Colorectal Cancer set a target of 80 percent for completing follow-up colonoscopy. A few integrated health systems have met this goal, but many fall far short. Delays in follow-up increase the risk for such cancer and detection at a later stage. National efforts are focused on establishing completion of colonoscopy as a standardized quality measure for health care systems. Patient-navigation programs can help patients overcome colorectal cancer screening barriers. The Centers for Disease Control and Prevention’s Community Preventive Services Task Force recommends such programs, but there is insufficient data on whether they improve colonoscopy completion for adults who have abnormal stool test results. The authors conducted a study to determine if patient navigation delivered to people with an abnormal stool test result could increase completion of follow-up colonoscopy at one year. The Predicting and Addressing Colonoscopy Non-Adherence in Community Settings (PRECISE) study assessed the impact of a patient-navigation program compared with usual care outreach on follow-up colonoscopy among patients with an abnormal fecal immunochemical test result. The study was conducted at a federally qualified health center that operated 32 clinics serving approximately 220,000 patients in western Washington. Fifty percent of study participants were identified as Hispanic or Latino. Using electronic health record data, the authors identified patients between 50 and 75 years old who received an abnormal fecal immunochemical test result in the previous month. Patients were excluded if they had life-limiting comorbid conditions. Patients were identified for the study between July 2019 and April 2022, with a pause from March 2, 2020 to Aug. 24, 2020 related to COVID-19 and an EHR conversion. The patients participated in a six-topic telephone-based patient-navigation program operated by navigators fluent in English and Spanish. Of 985 patients, 967 were included in the primary trial and randomized to receive patient navigation or usual standard of care. Receipt of follow-up colonoscopy was higher in the patient-navigation group than in the usual care group (55.1 and 42.1 percent, respectively; risk difference, 13.0 percentage points). The intervention effect was unchanged by patients’ probability of obtaining a colonoscopy without navigation. Patient probability was based on a predictive risk model to calculate participants’ probability of obtaining a colonoscopy without navigation services. The authors noted that despite the program’s success, a long time delay to colonoscopy (more than 220 days overall) remained. This suggests that additional efforts may be needed to expedite the procedure to avoid worse outcomes. The authors concluded that the study findings support the effectiveness of patient navigation for follow-up colonoscopy. However, they noted that a limitation of the study was that it spanned the COVID-19 pandemic, which created some additional barriers to receiving a follow-up colonoscopy.
Coronado GD, Petrik AF, Thompson JH, et al. Patient navigation to improve colonoscopy completion after an abnormal stool test result. Ann Intern Med. 2025. doi.10.7326/annals-24-01885
Correspondence: Dr. Gloria D. Coronado at gdcoronado@arizona.edu