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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

NCT ID: NCT00579787

Last Updated: 2010-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cervical Cancer

Keywords

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cervical cancer quality of life assessment behavioral

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Women with early stage cervical cancer undergoing radical trachelectomy

No interventions assigned to this group

2

Women with early stage cervical cancer undergoing radical hysterectomy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Memorial Sloan Kettering Cancer Center

Principal Investigators

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Jeanne Carter, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Related Info

Other Identifiers

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03-148

Identifier Type: -

Identifier Source: org_study_id