Clinical trial NCT04541784 - References

Vulvar Neoplasm — Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia

Citation(s)

•   Anders, S
  , Riethdorf, L., & Löning, T. (2001). Neoplasia and pre-neoplasia of the lower genital tract. Der Gynäkologe, 34(7), 590-598. https://doi.org/10.1007/s001290101061
•   Broglia E, Millings A, Barkham M
  Comparing counselling alone versus counselling supplemented with guided use of a well-being app for university students experiencing anxiety or depression (CASELOAD): protocol for a feasibility trial. Pilot Feasibility Stud. 2017 Jan 23;3:3. doi: 10.1186/s40814-016-0119-2. eCollection 2017.
•   Buttmann-Schweiger N, Klug SJ, Luyten A, Holleczek B, Heitz F, du Bois A, Kraywinkel K
  Incidence patterns and temporal trends of invasive nonmelanotic vulvar tumors in Germany 1999-2011. A population-based cancer registry analysis. PLoS One. 2015 May 28;10(5):e0128073. doi: 10.1371/journal.pone.0128073. eCollection 2015.
•   Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance
  Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
•   Creswell, J
  W., & Plano Clark, V. L. (2017). Designing and conducting mixed methods research (3rd ed.). Los Angeles: Sage Publications.
•   Denzin, N
  K., & Lincoln, Y. S. (2011). The Sage handbook of qualitative research (4th ed.). Thousand Oaks: Sage.
•   Dresing, T
  , & Pehl, T. (2011). Praxisbuch Transkription: Regelsysteme, Software und praktische Anleitungen für qualitative ForscherInnen (2. Auflage, Sept. 2011). Marburg: Eigenverlag.
•   Flick, U
  (2014). An introduction to qualitative research (Ed. 5). Los Angeles, Calif.: Sage.
•   Gray HJ
  Advances in vulvar and vaginal cancer treatment. Gynecol Oncol. 2010 Jul;118(1):3-5. doi: 10.1016/j.ygyno.2010.04.011. Epub 2010 May 15.
•   Graziottin A, Serafini A
  HPV infection in women: psychosexual impact of genital warts and intraepithelial lesions. J Sex Med. 2009 Mar;6(3):633-45. doi: 10.1111/j.1743-6109.2008.01151.x. Epub 2009 Jan 13. Review.
•   Grove, S
  K., Burns, N. P. D., & Gray, J. 1. (2012). The practice of nursing research: Appraisal, synthesis, and generation of evidence (7. ed.). Philadelphia Pa., London: Saunders.
•   Hampl, M
  , & Janni, W. (2012). Vulvakarzinom. Der Gynäkologe, 45(11), 865-872. https://doi.org/10.1007/s00129-012-2995-8
•   Jefferies H, Clifford C
  Invisibility: the lived experience of women with cancer of the vulva. Cancer Nurs. 2012 Sep-Oct;35(5):382-9. doi: 10.1097/NCC.0b013e31823335a1.
•   Kaushik S, Pepas L, Nordin A, Bryant A, Dickinson HO
  Surgical interventions for high-grade vulval intraepithelial neoplasia. Cochrane Database Syst Rev. 2014 Mar 4;(3):CD007928. doi: 10.1002/14651858.CD007928.pub3. Review.
•   Kobleder A, Raphaelis S, Glaus A, Fliedner M, Mueller MD, Gafner D, Gehrig L, Senn B
  Recommendations for symptom management in women with vulvar neoplasms after surgical treatment: An evidence-based guideline. Eur J Oncol Nurs. 2016 Dec;25:68-76. doi: 10.1016/j.ejon.2016.10.003. Epub 2016 Oct 22.
•   Leermakers ME, Pleunis N, Boll D, Hermans RH, Ezendam NP, Pijnenborg JM
  High Incidence of Erysipelas After Surgical Treatment for Vulvar Carcinoma: An Observational Study. Int J Gynecol Cancer. 2016 Mar;26(3):582-7. doi: 10.1097/IGC.0000000000000625.
•   Lincoln, Y
  S., & Guba, E. G. (1985). Naturalistic inquiry. Beverly Hills, Calif.: Sage Publications.
•   McFadden KM, Sharp L, Cruickshank ME
  The prospective management of women with newly diagnosed vulval intraepithelial neoplasia: clinical outcome and quality of life. J Obstet Gynaecol. 2009 Nov;29(8):749-53. doi: 10.3109/01443610903191285.
•   Mishel MH
  The measurement of uncertainty in illness. Nurs Res. 1981 Sep-Oct;30(5):258-63.
•   Philp S, Mellon A, Barnett C, D'Abrew N, White K
  The road less travelled: Australian women's experiences with vulval cancer. Eur J Cancer Care (Engl). 2017 Jan;26(1). doi: 10.1111/ecc.12465. Epub 2016 Feb 18.
•   Raphaelis S, Mayer H, Ott S, Hornung R, Senn B
  Effects of Written Information and Counseling on Illness-Related Uncertainty in Women With Vulvar Neoplasia. Oncol Nurs Forum. 2018 Nov 1;45(6):748-760. doi: 10.1188/18.ONF.748-760.
•   Raphaelis S, Mayer H, Ott S, Mueller MD, Steiner E, Joura E, Senn B
  The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study. Gynecol Oncol. 2017 Jul;146(1):114-122. doi: 10.1016/j.ygyno.2017.04.024. Epub 2017 May 5.
•   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 sectional study. Gynecol Oncol. 2013 Apr;129(1):234-40. doi: 10.1016/j.ygyno.2012.12.038. Epub 2013 Jan 3.
•   Senn B, Gafner D, Happ MB, Eicher M, Mueller MD, Engberg S, Spirig R
  The unspoken disease: symptom experience in women with vulval neoplasia and surgical treatment: a qualitative study. Eur J Cancer Care (Engl). 2011 Nov;20(6):747-58. doi: 10.1111/j.1365-2354.2011.01267.x. Epub 2011 Jul 19.
•   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
  , Gafner, D., Raphaelis, S., Meyer, G., Mayer, H., White, K.,. . . Mueller, M. D. (2013). Testing the counsellig program
•   U
  S. Department of Health and Human Services FDA Center for Drug Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research; U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006 Oct 11;4:79.
•   Van der Zee AG, Oonk MH, De Hullu JA, Ansink AC, Vergote I, Verheijen RH, Maggioni A, Gaarenstroom KN, Baldwin PJ, Van Dorst EB, Van der Velden J, Hermans RH, van der Putten H, Drouin P, Schneider A, Sluiter WJ
  Sentinel node dissection is safe in the treatment of early-stage vulvar cancer. J Clin Oncol. 2008 Feb 20;26(6):884-9. doi: 10.1200/JCO.2007.14.0566.

Effectiveness of a Multidimensional Mobile App Intervention "WOMAN-PRO III" to Reduce Postsurgical Symptom Induced Distress in Patients With Vulvar Neoplasia: A Mixed Methods Project

Details for clinical trial NCT04541784