TRAIL-CC: Trachelectomy, Radical Hysterectomy, and Intimate Life After Cervical Cancer Study - Full Text View

Purpose

The objective of this study is to compare radical hysterectomy with trachelectomy on outcomes related to intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.

Condition
Cervical Cancer

Study Type:	Observational
Study Design:	Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Hysterectomy

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Enrollment:	33
Study Start Date:	January 2006
Study Completion Date:	December 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Show Detailed Description

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Women diagnosed with cervical or endometrial cancer

Criteria

Inclusion Criteria:

Women who have a diagnosis of cervical cancer
Women who are scheduled for either a radical hysterectomy or radical trachelectomy at the British Columbia Cancer Agency - Vancouver Cancer Centre
Proficient in English

Exclusion Criteria:

No woman who meets the inclusion criteria will be excluded from participating.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278798

Locations

Canada, British Columbia
British Columbia Cancer Agency
Vancouver, British Columbia, Canada, V5Z 1M9

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Lori A Brotto, PhD

University of British Columbia

More Information

Additional Information:

primary investigator's website This link exits the ClinicalTrials.gov site

Publications:

Bergmark K, Avall-Lundqvist E, Dickman PW, Henningsohn L, Steineck G. Vaginal changes and sexuality in women with a history of cervical cancer. N Engl J Med. 1999 May 6;340(18):1383-9.

Bernardini M, Barrett J, Seaward G, Covens A. Pregnancy outcomes in patients after radical trachelectomy. Am J Obstet Gynecol. 2003 Nov;189(5):1378-82.

Boss EA, van Golde RJ, Beerendonk CC, Massuger LF. Pregnancy after radical trachelectomy: A real option? Gynecol Oncol. 2005 Dec;99(3 Suppl):S152-6. Epub 2005 Sep 2.

Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. Erratum in: Cancer 2000 Nov 15;89(10):2144.

Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56.

Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79.

Plante M, Renaud MC, Francois H, Roy M. Vaginal radical trachelectomy: an oncologically safe fertility-preserving surgery. An updated series of 72 cases and review of the literature. Gynecol Oncol. 2004 Sep;94(3):614-23. Review.

Plante M, Renaud MC, Hoskins IA, Roy M. Vaginal radical trachelectomy: a valuable fertility-preserving option in the management of early-stage cervical cancer. A series of 50 pregnancies and review of the literature. Gynecol Oncol. 2005 Jul;98(1):3-10. Review.

Sonoda Y, Abu-Rustum NR, Gemignani ML, Chi DS, Brown CL, Poynor EA, Barakat RR. A fertility-sparing alternative to radical hysterectomy: how many patients may be eligible? Gynecol Oncol. 2004 Dec;95(3):534-8.

Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53.

Weijmar Schultz, W. C. M., van de Wiel, H. B. M. & Bouma, J. (1991) Psychosexual functioning after treatment for cancer of the cervix: A comparative and longitudinal study. Int J Gynecol Cancer, 1, 37-46.

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00278798 History of Changes
Other Study ID Numbers:	C05-0591
Study First Received:	January 16, 2006
Last Updated:	July 10, 2012
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

tracehelectomy
radical hysterectomy

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013