Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence in Patients Diagnosed With Early-stage Breast Cancer and Ovarian Cancer in Remission
The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.
∙ 1, Aged ≥ 21 2. Diagnosis of:
• early-stage breast cancer at low risk of recurrence
‣ defined as clinical stage 1 or 2
⁃ completed primary treatment (surgery, chemotherapy \[adjuvant, patients may continue to be treated with neoadjuvant\], and/or radiation) \> 6 months ago
⁃ oncologist reported risk of recurrence at 10 years \< 20%
• late-stage ovarian cancer at high risk of recurrence
‣ defined as Clinical stage 3 or 4
⁃ currently in remission
⁃ oncologist reported risk of recurrence at 10 years \> 80% 2. Functional Status defined as:
• Eastern Cooperative Oncology Group (ECOG) ≤1
• Palliative Performance Scale (PPS) ≥60%
• Ability to tolerate PO medication administration 4. Fear of recurrence at screening and baseline 5. Have an identified support person
• Agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing 6. Participants of childbearing potential must agree to practice an effective means of birth control throughout the duration of the study.