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
November 30, 2010 updated by: Memorial Sloan Kettering Cancer Center
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
72
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Women with early stage cervical cancer undergoing either radical trachelectomy or radical hysterectomy
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Women with early stage cervical cancer undergoing radical trachelectomy
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2
Women with early stage cervical cancer undergoing radical hysterectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jeanne Carter, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
November 1, 2010
Study Completion (Actual)
November 1, 2010
Study Registration Dates
First Submitted
December 19, 2007
First Submitted That Met QC Criteria
December 19, 2007
First Posted (Estimate)
December 24, 2007
Study Record Updates
Last Update Posted (Estimate)
December 2, 2010
Last Update Submitted That Met QC Criteria
November 30, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-148
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.