202P - Participant perceptions and mammography adherence from DETECT-A: The first prospective interventional trial of a multi-cancer early detection (MCED) blood test

Background

MCED tests may improve early cancer detection, but the impact of MCED testing on anxiety and standard of care (SOC) screening adherence is unknown. The DETECT-A trial evaluated the CancerSEEK MCED test in 9,911 women without a cancer history (Science, 359:6499, 2020). DETECT-A participants without a cancer diagnosis were invited to a follow-up observational study involving annual surveys. Here we report on participant satisfaction, anxiety, intent to adhere to SOC cancer screening, and adherence to breast cancer screening.

Methods

The survey, conducted approximately 3 years after DETECT-A enrollment, assessed: a) whether participants regretted DETECT-A participation or would participate again, b) how likely they were to adhere to routine cancer screenings, and c) how participation affected their anxiety. Adherence to biennial mammography screening was assessed at the month of survey completion for screening-eligible participants with evaluable medical records.

Results

Of the 7573 DETECT-A participants contacted, 3,870 (51%) completed a survey. Of the 3,788 respondents who answered all survey questions, 96.9% indicated no participation regret, 98.8% would participate again, 99.5% reported being equally or more likely to adhere to SOC screening, and 98.7% reported no change in or reduced anxiety. Of 1,053 participants eligible for mammography with available health records, 93.4% (n=984) were adherent with mammography screening. 94.3% of participants with false positive (FP) results who completed a survey (n = 35) reported no change or a reduction in anxiety; 5.7% (95%CI 1.6%-18.6%) reported an increase in anxiety compared to 1.3% (95% CI 0.9%-1.7%) of participants with true negative results (p = 0.07).

Conclusions

A follow-up study of MCED participant survey responses revealed high levels of participant satisfaction, intent to adhere to SOC screening, and mammography adherence. Most participants reported no change or a decrease in anxiety. This data suggest that MCED testing with imaging-based diagnostic resolution does not significantly increase anxiety or negatively impact mammography adherence for most participants, including those with FP results.

Clinical trial identification

Editorial acknowledgement

Medical writing and editorial support was provided by Carolyn Hall, PhD, and Feyza Sancar, PhD (Exact Sciences, Madison, WI).

Legal entity responsible for the study

The authors.

Funding

Exact Sciences Corporation.

Disclosure

N. Papadopoulos: Financial Interests, Personal, Advisory Role: Exact Sciences Corporation, Haystack Oncology; Financial Interests, Personal, Stocks or ownership: Exact Sciences Corporation, Haystack Oncology, ManaT Bio, Personal Genome Diagnostics, NeoPhore, CAGE Pharma; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for Intellectual Property owned and managed by Johns Hopkins University: Johns Hopkins University. A.M. Lennon: Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for Intellectual Property owned and managed by Johns Hopkins University: Johns Hopkins University. P. Elias: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation. S. Rego: Financial Interests, Personal, Full or part-time Employment, travel/accommodation expenses: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation. O. Choudhry: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation. D. Flake: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation. J. Cohen: Financial Interests, Personal, Stocks or ownership: Haystack Oncology; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for Intellectual Property owned and managed by Johns Hopkins University: Johns Hopkins University. C. Douville: Financial Interests, Personal, Advisory Role, Consulting and travel/accomodations expenses: Exact Sciences Corporation; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for Intellectual Property owned and managed by Johns Hopkins University: Johns Hopkins University. A. Honushefsky: Financial Interests, Institutional, Research Funding: Freenome Holdings, Inc, Exact Sciences Corporation. I. Kinde: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for intellectual property owned and managed by Johns Hopkins University: Johns Hopkins University. A. Klein: Financial Interests, Personal, Advisory Role, consulting: Merck; Financial Interests, Personal, Advisory Board, consulting: OptumInsight; Financial Interests, Personal, Funding: OptumLabs. Z. Salvati: Financial Interests, Institutional, Research Funding: Exact Sciences Corporation. C. Tomasetti: Financial Interests, Personal, Advisory Role: Haystack Oncology, PrognomIQ; Financial Interests, Personal, Stocks or ownership: Haystack Oncology, PrognomIQ; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for intellectual property owned and managed by Johns Hopkins University: Johns Hopkins University. E. Wagner: Financial Interests, Institutional, Research Funding: Freenome Holdings, Inc, Exact Sciences Corporation. C. Walter: Financial Interests, Institutional, Research Funding: Freenome Holdings, Inc, Exact Sciences Corporation. E. Fishman: Financial Interests, Personal, Other, Honoraria: GE Healthcare, HipGraphics; Financial Interests, Institutional, Research Funding: GE Healthcare, HipGraphics, GE Healthcare; Financial Interests, Institutional, Other, Honoraria: Siemens Healthineers. K. Kinzler: Financial Interests, Personal, Advisory Role, I also own stock: Haystack Oncology, Exact Sciences Corporation, Cage Pharma, ManaT Bio, Neophore; Financial Interests, Personal, Advisory Board, I also own stock.: Personal Genome Diagnostics; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for intellectual property owned and managed by Johns Hopkins University.: Johns Hopkins University. B. Vogelstein: Financial Interests, Personal, Advisory Role, I also own stock: Cage Pharma, Catalio Capital Management, NeoPhore; Financial Interests, Personal, Stocks or ownership: ManaT Bio, Haystack Oncology, Personal Genome Diagnostics, Exact Sciences Corporation; Financial Interests, Personal, Licencing Fees or royalty for IP, I receive royalties for intellectual property owned and managed by Johns Hopkins University: Johns Hopkins University. T.M. Beer: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation, Salarius Pharmaceuticals; Financial Interests, Personal, Advisory Role, I also own stock: Arvinas; Financial Interests, Personal, Advisory Role: AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Constellation Pharmaceuticals, Dantari Pharmaceuticals, GSK, GRAIL, Janssen, Pfizer, Sanofi, Sapience Therapeutics. A. Buchanan: Financial Interests, Personal, Full or part-time Employment: IMPACT Pharmaceuticals; Financial Interests, Institutional, Research Funding: Exact Sciences Corporation, Freenome Holdings, Inc; Financial Interests, Personal, Licencing Fees or royalty for IP: MeTree and You, Inc.