Clinical Trial Summary

---

Phase

Phase 4

---

Funding Agency/Sponsor

Externally Peer-Reviewed

---

Disease

Population Sciences

---

Enrollment Eligibility

Inclusion Criteria:
1. Must meet the criterion of a score of >14 on the Impact of Event Scale-Intrusion scale
(IES-I48) for cancer-specific distress or self-report at least moderate distress
(score of 4 or greater) on a screening question, "How would you rate your distress
level, over the past week, on a scale of 0 to 10, with 0 meaning no distress and 10
being extreme distress"
2. No prior history of cancer (with the exception of non-melanoma skin cancer)
3. Life expectancy of > 12 months.
4. No diagnosis of major psychiatric condition or mental disorder (i.e. schizophrenia,
psychosis, and/or bipolar disorder) or active (in the past 12 months) Major Depressive
Disorder (MDD), panic disorder, Post Traumatic Stress Disorder (PTSD) diagnosis or
history of suicide thoughts, attempts or plans.
5. No substance dependency in the past 12 months.
6. No acute or chronic co-morbid medical condition with known effects on the immune
system (e.g., HIV infection, autoimmune diseases)
7. No prior neo-adjuvant therapy
8. No current medications that act as direct immunomodulators (e.g., Granulocyte
Macrophage Colony Stimulating Factor (GM-CSF), interferons)
9. No significant cognitive impairment, must score <31 on the Telephone Interview for
Cognitive Status (TICS)49.
10. At least a 6th grade reading level in English and be available for follow-up
11. Women age 50 and older diagnosed with stage 0-III breast cancer.
Exclusion Criteria:
- Does not meet all Inclusion Criteria.

---