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

NCT00579787 | Completed

• 1 other identifier: 03-148
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Cancer

Keywords

cervical cancer; quality of life assessment; behavioral

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Study Arms (2)

1

Women with early stage cervical cancer undergoing radical trachelectomy

2

Women with early stage cervical cancer undergoing radical hysterectomy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeanne Carter, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: January 1, 2004
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 2, 2010

Record last verified: 2010-11

Locations

US (1)