A Phase 1b study of Psilocybin Assisted Psychotherapy to address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission

Primary Objective

Measure the preliminary effect of psilocybin assisted psychotherapy on fear of recurrence.

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Description

A study conducted to determine if a single dose of 25 mg. of psilocybin, in combination with therapy, will address fear of recurrence in patients diagnosed with early-stage breast cancer and ovarian cancer in remission

Details
Age
Adult
Eligibility
Female adults with early-stage breast cancer or late-stage ovarian cancer who have a fear of recurrence. **Target population: Female adults with early-stage breast cancer at low risk for recurrence and late-stage ovarian cancer at high risk for recurrence. **Patients with diagnosis of cancer who may have recently completed surgical or chemotherapy. Given the significant functional disability (e.g., unable to carry out work activities), but participants cannot be so functionally impaired (e.g., bed bound and unable to care for self) or near death that they would be unable to adequately participate in the trial. **Screening and baseline score on the Fear of Recurrence Inventory > 20.
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of STACY FISCHER

STACY FISCHER

Study ID

Protocol Number: 23-1455

More information available at ClinicalTrials.gov: NCT06430541

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