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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Cancer Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2010
Study completion: 2010
First posted: Dec 24, 2007
Registry last updated: Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed