Prospective Study Assessing Emotional, Sexual and Quality of Life Concerns Of Women Undergoing Removal of the Cervix Versus Removal of the Uterus,Ovaries and Fallopian Tubes For Treatment Of Early Stage Cervical Cancer

This study has been completed.
Sponsor:
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00579787
First received: December 19, 2007
Last updated: November 30, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to will help us understand how two treatments impact women with early stage cervical cancer: a radical hysterectomy, which removes the entire uterus, the ovaries, and fallopian tubes versus a radical trachelectomy which removes the cervix, which is the bottom part of the uterus. The second leaves the rest of the uterus, the ovaries, and fallopian tubes. This means that there is a chance that the woman might be able to get pregnant in the future with this type of treatment. We believe that these two operations need further study to see how they impact women. This study will look at emotions and issues of fertility. The study will also ask about quality of life and sexual functioning. What we learn from this study will help us give better information to women considering these treatments.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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). [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2004
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Women with early stage cervical cancer undergoing radical trachelectomy
2
Women with early stage cervical cancer undergoing radical hysterectomy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with early stage cervical cancer undergoing either radical trachelectomy or radical hysterectomy

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579787

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jeanne Carter, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jeanne Carter, PhD, Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00579787     History of Changes
Other Study ID Numbers: 03-148
Study First Received: December 19, 2007
Last Updated: November 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
cervical cancer
quality of life assessment
behavioral

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 July 20, 2014