NCT02948413 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Cella DF, Mahon SM, Donovan MI
Cancer recurrence as a traumatic event. Behav Med. 1990 Spring;16(1):15-22.
Gurevich M, Devins GM, Rodin GM
Stress response syndromes and cancer: conceptual and assessment issues. Psychosomatics. 2002 Jul-Aug;43(4):259-81. Review.
Zabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S
The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28.

Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials

Clinical trial NCT02948413 - References