A Prospective Study Assessing the Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Radical Trachelectomy Versus Radical Hysterectomy For Treatment Of Early Stage Cervical Cancer
18 Years
45 Years
Female
Cervical Cancer
Trial Information
A Prospective Study Assessing the Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Radical Trachelectomy Versus Radical Hysterectomy For Treatment Of Early Stage Cervical Cancer
This project will prospectively assess and describe the emotional, sexual and quality of
life impact of radical trachelectomy in comparison to the standard treatment of radical
hysterectomy in women with early stage cervical cancer over a two year time period. Women
being considered for radical trachelectomy with laparoscopic pelvic lymphadenectomy or
radical hysterectomy (abdominal, laparoscopic or schauta) will be approached for study
participation prior to undergoing surgery. After providing informed consent, participants
will be given a survey questionnaire pre-operatively and asked to complete follow-up surveys
post-operatively at follow up medical appointments at 3 months, 6 months, 12 months, 18
months and 24 months. We will assess the following domains in these women; mood, sexual
functioning, and quality of life in addition to issues of fertility and treatment choice.
The survey will take approximately 30 minutes to complete. The findings will be used to
provide additional information to women considering these procedures and enable future
interventions to be designed to meet any identified needs. In addition, the findings of this
study will also be presented for consideration of a multi-center feasibility study.
Inclusion Criteria:
- Patients should be suitable surgical candidates and completed the surgical consenting
process with their gynecologic oncology surgeon.
- Confirmed invasive cervical cancer: squamous, adeno, or adenosquamous.
- FIGO Stage IA1 with lymph-vascular space involvement or stage IA2-IB2).
- Consented for a radical trachelectomy (vaginal/abdominal) or radical hysterectomy
(laparoscopic/abdominal).
- Have not started or completed childbearing.
- Strong desire to preserve fertility (trachelectomy group only).
- At least 18 years of age and not older than 45 years at the time of treatment.
- Able to read/ speak the English language.
- Able to provide informed conse
Exclusion Criteria:
- Inability to participate in an informed consent process.
- Patients with a psychiatric disorder precluding response to the survey.
- Patients that are upstaged at the time of surgery and will require adjuvant therapy.
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Assess emotional, sexual and quality of life of women with early stage cervical cancer undergoing radical trachelectomy and to compare same between women undergoing radical trachelectomy versus standard radical hysterectomy (all forms).
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Jeanne Carter, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
03-148
NCT ID:
NCT00579787
Start Date:
January 2004
Completion Date:
November 2010
Related Keywords:
- Cervical Cancer
- cervical cancer
- quality of life assessment
- behavioral
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
