EFFECT OF MULTI-CANCER EARLY DETECTION (MCED) TESTING ON PARTICIPANT-REPORTED OUTCOMES FOR MENTAL HEALTH-RELATED QUALITY OF LIFE (MHRQOL) IN PATHFINDER 2
Author(s)
Charles McDonnell III, MD, FACR1, Dax Kurbegov, MD2, Karthik V. Giridhar, MD3, Kevin C. Oeffinger, MS4, Marc R. Matrana, MD5, Benjamin Rybicki, PhD6, Cora N Sternberg, MD7, Raymond H. Kim, MD, PhD, FCCMG, FACMG8, Roland Matthews, MD9, Alan R. Roth, DO, FAAFP, FAAHPM10, Raevti Bole, MD MA11, Philip A. Kovoor, MD12, Margaret McCusker, MD, MS13, Margarita Lopatin, MS13, Anuraag Kansal, PhD13, Nima Nabavizadeh, MD14.
1Sutter Health Research Institute, Sacramento, CA, USA, 2Healthcare Sarah Cannon Cancer Network, Nashville, TN, USA, 3Mayo Clinic, Rochester, MN, USA, 4Duke University Health System, Durham, NC, USA, 5Ochsner Clinic Foundation, New Orleans, LA, USA, 6Henry Ford Health, Detroit, MI, USA, 7Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA, 8University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada, 9Morehouse School of Medicine, Atlanta, GA, USA, 10Jamaica Hospital Medical Center, Queens, NY, USA, 11Cleveland Clinic, Cleveland, OH, USA, 12Texas Oncology-Plano West, Dallas, TX, USA, 13GRAIL, Inc., Menlo Park, CA, USA, 14Oregon Health & Science University, Portland, OR, USA.
1Sutter Health Research Institute, Sacramento, CA, USA, 2Healthcare Sarah Cannon Cancer Network, Nashville, TN, USA, 3Mayo Clinic, Rochester, MN, USA, 4Duke University Health System, Durham, NC, USA, 5Ochsner Clinic Foundation, New Orleans, LA, USA, 6Henry Ford Health, Detroit, MI, USA, 7Englander Institute for Precision Medicine, Weill Cornell Medicine, New York, NY, USA, 8University Health Network, Princess Margaret Cancer Centre, Toronto, ON, Canada, 9Morehouse School of Medicine, Atlanta, GA, USA, 10Jamaica Hospital Medical Center, Queens, NY, USA, 11Cleveland Clinic, Cleveland, OH, USA, 12Texas Oncology-Plano West, Dallas, TX, USA, 13GRAIL, Inc., Menlo Park, CA, USA, 14Oregon Health & Science University, Portland, OR, USA.
OBJECTIVES: Participant-reported MHRQoL and perceptions of an MCED test following MCED testing were investigated in the prospective, interventional PATHFINDER 2 study (NCT05155605).
METHODS: PATHFINDER 2 enrolled adults aged ≥50y without clinical suspicion of cancer. Short Form 12-Item Health Survey (SF-12v2) mental component summary (MCS) and subscale scores were assessed before MCED testing (pretest), after result disclosure (posttest), at diagnostic resolution (resolution; for participants with positive MCED results), and at 12m. An adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire was administered posttest. Single-item questions measured MCED test satisfaction and attitudes towards future MCED testing posttest and at 12m. True-positive/false-positive/true-negative/false-negative MCED results were defined using cancer status at 12m.
RESULTS: Of 35,350 analyzable participants, 305 had positive MCED results. For participants with true-positive MCED results, mean (SD) SF-12v2 MCS scores decreased from pretest (53.3 [7.9], n=166) to posttest (49.5 [10.3], n=108) and resolution (48.9 [11.3], n=74), and improved by 12m (51.8 [8.3], n=101). Scores remained mostly consistent for those with false-positive (pretest: 54.2 [7.1], n=129; posttest: 53.7 [8.3], n=81; resolution: 55.4 [5.7], n=61; 12m: 54.0 [7.2], n=69) or true-negative (pretest: 54.1 [7.0], n=33,218; posttest: 53.8 [7.3], n=25,334; 12m: 53.4 [7.4], n=20,849) MCED results. Scores of participants with false-negative MCED results were lower at 12m (pretest: 54.7 [6.9], n=250; posttest: 54.0 [7.8], n=201; 12m: 52.0 [9.3], n=173). Subscale scores followed similar patterns across groups/timepoints. All scores remained within the average general population range (50 [10]). MICRA scores were higher (greater negative impact) for participants with positive vs negative MCED results (27.6 [15.8] vs 7.8 [7.2]). 96.5% of participants were satisfied with MCED testing; 94.6% were likely/very likely to undergo subsequent MCED testing.
CONCLUSIONS: MCED testing and related activities affected MHRQoL of participants with true-positive MCED results, with improvement by 12m. Patterns are consistent with published studies of single-cancer screening program participants.
METHODS: PATHFINDER 2 enrolled adults aged ≥50y without clinical suspicion of cancer. Short Form 12-Item Health Survey (SF-12v2) mental component summary (MCS) and subscale scores were assessed before MCED testing (pretest), after result disclosure (posttest), at diagnostic resolution (resolution; for participants with positive MCED results), and at 12m. An adapted Multidimensional Impact of Cancer Risk Assessment (MICRA) questionnaire was administered posttest. Single-item questions measured MCED test satisfaction and attitudes towards future MCED testing posttest and at 12m. True-positive/false-positive/true-negative/false-negative MCED results were defined using cancer status at 12m.
RESULTS: Of 35,350 analyzable participants, 305 had positive MCED results. For participants with true-positive MCED results, mean (SD) SF-12v2 MCS scores decreased from pretest (53.3 [7.9], n=166) to posttest (49.5 [10.3], n=108) and resolution (48.9 [11.3], n=74), and improved by 12m (51.8 [8.3], n=101). Scores remained mostly consistent for those with false-positive (pretest: 54.2 [7.1], n=129; posttest: 53.7 [8.3], n=81; resolution: 55.4 [5.7], n=61; 12m: 54.0 [7.2], n=69) or true-negative (pretest: 54.1 [7.0], n=33,218; posttest: 53.8 [7.3], n=25,334; 12m: 53.4 [7.4], n=20,849) MCED results. Scores of participants with false-negative MCED results were lower at 12m (pretest: 54.7 [6.9], n=250; posttest: 54.0 [7.8], n=201; 12m: 52.0 [9.3], n=173). Subscale scores followed similar patterns across groups/timepoints. All scores remained within the average general population range (50 [10]). MICRA scores were higher (greater negative impact) for participants with positive vs negative MCED results (27.6 [15.8] vs 7.8 [7.2]). 96.5% of participants were satisfied with MCED testing; 94.6% were likely/very likely to undergo subsequent MCED testing.
CONCLUSIONS: MCED testing and related activities affected MHRQoL of participants with true-positive MCED results, with improvement by 12m. Patterns are consistent with published studies of single-cancer screening program participants.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR76
Topic
Clinical Outcomes, Medical Technologies, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology