NCT03321149 - 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)

Arain M, Campbell MJ, Cooper CL, Lancaster GA
What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol. 2010 Jul 16;10:67. doi: 10.1186/1471-2288-10-67. Review.
Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al
The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9.
Esper P, Mo F, Chodak G, Sinner M, Cella D, Pienta KJ
Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument. Urology. 1997 Dec;50(6):920-8.
Gilson ND, Faulkner G, Murphy MH, Meyer MR, Washington T, Ryde GC, Arbour-Nicitopoulos KP, Dillon KA
Walk@Work: An automated intervention to increase walking in university employees not achieving 10,000 daily steps. Prev Med. 2013 May;56(5):283-7. doi: 10.1016/j.ypmed.2013.01.022. Epub 2013 Feb 13.
Kuijpers W, Groen WG, Aaronson NK, van Harten WH
A systematic review of web-based interventions for patient empowerment and physical activity in chronic diseases: relevance for cancer survivors. J Med Internet Res. 2013 Feb 20;15(2):e37. doi: 10.2196/jmir.2281. Review.
Leon AC, Davis LL, Kraemer HC
The role and interpretation of pilot studies in clinical research. J Psychiatr Res. 2011 May;45(5):626-9. doi: 10.1016/j.jpsychires.2010.10.008. Epub 2010 Oct 28.
Mitchell MS, Goodman JM, Alter DA, John LK, Oh PI, Pakosh MT, Faulkner GE
Financial incentives for exercise adherence in adults: systematic review and meta-analysis. Am J Prev Med. 2013 Nov;45(5):658-67. doi: 10.1016/j.amepre.2013.06.017. Review.

RiseTx: Testing the Feasibility of a Web Application for Reducing Sedentary Behavior Among Prostate Cancer Survivors Receiving Androgen Deprivation Therapy

Details for clinical trial NCT03321149

Clinical trial NCT03321149 - References