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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


N/A
18 Years
45 Years
Not Enrolling
Female
Cervical Cancer

Thank you

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 CenterNew York, New York  10021