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Psilocybin-assisted Psychotherapy to Treat Fear of Cancer Recurrence in Early- Stage Breast Cancer

Award Number: R01CA312541
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/08/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Psilocybin-assisted Psychotherapy to Treat Fear of Cancer Recurrence in Early- Stage Breast Cancer - Project Summary/Abstract Fear of cancer recurrence (FCR) is a significant component of anxiety experienced almost universally by breast cancer survivors and is arguably the number one unmet need of cancer survivors following initial oncologic treatment. Up to 70% of women with early-stage breast cancer experience moderate to severe FCR. Current treatment options for FCR include only psychosocial treatments of limited efficacy, and no effective medications. The lack of effective psychosocial and pharmacologic treatments for FCR is a critical shortcoming in the care of women who are survivors of early-stage breast cancer, representing an unmet need in the care of FCR. Recent pilot randomized trials suggest that single-dose psilocybin-assisted psychotherapy (PAP) for people with both early and late-stage breast cancer-related psychiatric and existential distress, is safe, producing rapid, robust, and sustained (e.g., months to years) improvements in anxiety and depression, as well as sustained benefits in existential distress and quality of life. A qualitative study identified reduced FCR as one of the most common phenomenological themes of PAP in people with cancer. With most of the research to date of psychedelic therapies in cancer focusing on advanced cancer, there has not yet been a well-designed RCT of PAP specifically targeting a homogenous group of patients with early stage cancer, and none that has specifically targeted FCR. We propose to assess the strength and durability of therapeutic effects of PAP on clinically significant FCR, among 100 women with early-stage breast cancer following initial cancer treatment. This will be a double-blind, parallel-design, placebo-controlled, two-center RCT comparing a single 25mg dose of psilocybin to active placebo (psilocybin 5mg), both delivered in conjunction with a psychotherapy platform adopted from our prior work. This study will have the following aims: 1) To assess the short- and long-term effects of PAP on FCR and other mental health outcomes (e.g., anxiety, depression, and existential distress); 2) To assess the effects of psilocybin on QOL; and 3) To study potential psychological therapeutic mechanisms of PAP, we will assess mediational influences of self-reported acute psilocybin-induced experiences (ego dissolution, psychological insight) and sub-acute post-dosing changes (psychological flexibility, avoidance, rumination, hopelessness, death anxiety) on short- and long- term FCR.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2027 ( Subtotal = $0 )
2027	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Cancer Treatment Research	000	1	10/14/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2026 ( Subtotal = $693,638 )
2026	2026	NEW YORK UNIVERSITY	550 1ST AVE	NEW YORK	NY	10016	NEW YORK	USA	Cancer Treatment Research	000	1	9/8/2026	NEW	$693,638
														Subtotal = $693,638

Grand Total All Awards = $693,638

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Psilocybin-assisted Psychotherapy to Treat Fear of Cancer Recurrence in Early- Stage Breast Cancer

Award Number: R01CA312541

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/08/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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