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Psychosocial impact associated with a multicancer early detection test (PATHFINDER): a prospective, multicentre,
Lincoln Nadauld1, Charles H McDonnell2, Christina A Dilaveri3
1Culmination Bio, St George, UT, USA.
Multicancer early detection (MCED) testing showed minimal patient distress, with negative effects from positive cancer signal detected (CSD) results being small and temporary. The study indicates potential clinical benefits of MCED for early cancer detection with acceptable patient-reported outcomes.
Area of Science:
- Oncology
- Genomics
- Public Health
Background:
- The PATHFINDER study investigated multicancer early detection (MCED) testing in an outpatient ambulatory setting.
- Patient-reported outcomes (PROs) were collected as secondary and exploratory measures.
Purpose of the Study:
- To assess patient-reported outcomes and perceptions following MCED testing.
- To evaluate the impact of MCED test result disclosure on distress, anxiety, quality of life, and satisfaction.
Main Methods:
- A prospective, multicentre cohort study enrolled 6621 adults aged 50+ without clinical suspicion of cancer.
- PRO instruments included MICRA for distress, PROMIS Anxiety for anxiety symptoms, and SF-12v2 for quality of life.
- Exploratory objective assessed adherence to guideline-recommended screening.
Main Results:
- Of 6621 participants, 92 had a cancer signal detected (CSD) and 6529 had no cancer signal detected (NCSD).
- Mean general anxiety scores increased transiently in true-positive and false-positive groups post-disclosure, returning to baseline within 12 months.
- High satisfaction (97.1%) reported with MCED testing, with 95.6% likely to adhere to future screening recommendations.
Conclusions:
- Negative patient-reported effects from CSD results were small and temporary, returning to baseline within 12 months.
- MCED testing demonstrates potential clinical benefit for early cancer detection with minimal patient distress.
- Findings support the clinical utility of MCED testing in an ambulatory population.
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