NCT01675505 - 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)

Jimmie C
Holland, William S. Breitbart, Paul B.Jacobsen, Marguerite S. Lederberg, Matthew J. Loscalzo, Ruth McCorkle. Psycho-oncology, second edition, Oxford University Press, 2010 National Comprehensive Cancer Network. Distress management. Clinical practice guidelines. J Natl Compr Canc Netw. 2003;1:344-74. Ward WL, Hahn EA, Mo F, Hernandez L, Tulsky DS, Cella D. Reliability and validity of the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) quality of life instrument. Qual Life Res. 1999;8:181-95. Watson M, Law M, dos Santos M, Greer S, Baruch J, Bliss J. The Mini-MAC: further development of the Mental Adjustment to Cancer Scale. J Psychosoc Oncol1994;12:33-46.

Psychological Well-being Outcomes in Disease-free Survivors of Colorectal Cancer Following Curative Surgery

Clinical trial NCT01675505 - References