NCT01986725 - 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)

Gafner D, Eicher M, Spirig R, Senn B
[Between anxiety and hope: the experiences of women with vulval intraepithelial neoplasia during their illness trajectory - a qualitative approach]. Pflege. 2013 Apr;26(2):85-95. doi: 10.1024/1012-5302/a000273. German
Senn B, Eicher M, Mueller MD, Engberg S, Spirig R
[Needs based nursing care in gynecology. "My symptom diary"]. Krankenpfl Soins Infirm. 2012;105(5):32-3. German.
Senn B, Eicher M, Mueller MD, Gafner D, Engberg S, Spirig R
[Development and validation of a patient reported outcome instrument for women with vulvar cancers and surgical treatment - a mixed method study]. Pflege. 2013 Feb;26(1):65-8. doi: 10.1024/1012-
Senn B, Eicher M, Mueller MD, Hornung R, Fink D, Baessler K, Hampl M, Denhaerynck K, Spirig R, Engberg S
A patient-reported outcome measure to identify occurrence and distress of post-surgery symptoms of WOMen with vulvAr Neoplasia (WOMAN-PRO) - a cross
Senn B, Mueller MD, Cignacco EL, Eicher M
Period prevalence and risk factors for postoperative short-term wound complications in vulvar cancer: a cross-sectional study. Int J Gynecol Cancer. 2010 May;20(4):646-54. doi: 10.1111/IGC.0b013e3181d92723.
Senn B, Mueller MD, Hasenburg A, Blankenstein T, Kammermann B, Hartmann A, Donovan H, Eicher M, Spirig R, Engberg S
Development of a postsurgical patient-reported outcome instrument for women with vulvar neoplasia. Oncol Nurs Forum. 2012 Nov;39(6):E489-9

The Impact of the Self-management Intervention "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence: A Mixed-Methods Project

Details for clinical trial NCT01986725

Clinical trial NCT01986725 - References