Clinical Trial on Cervical Cancer - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Cervical Cancer

Detailed Description

Improvements in our treatment of these cancers has resulted in an increased focus on quality of life issues. Sexual health is one such important aspect of quality of life that is often disrupted in cervical cancer survivors. However, currently there are no established treatments for such sexual problems, often leaving women and their partners with long-term difficulties that interfere in other aspects of their relationship and lives.

Treatment of cervical cancer involves hysterectomy (i.e. removal of the uterus), and commonly bilateral salpingo-oophorectomy (BSO; i.e. bilateral removal of the ovaries and fallopian tubes). Hysterectomy results in direct physical consequences to sexual function which have been attributed to probable autonomic nerve damage (Butler-Manuel et al., 2000; 2002; Weijmar Schultz et al., 1991). Depending on the extent of disease, hysterectomy may be either simple (i.e. surgical removal of the uterus without excision of adjoining tissue) or radical (i.e. surgical removal of the uterus, the parametria and uterosacral ligaments, the upper portion of the vagina, and the pelvic lymph nodes).

In the last two decades, a new procedure known as trachelectomy, has surfaced to treat early stages of cervical cancer. Unlike radical hysterectomy, the trachelectomy procedure aims to preserve the fertility in young women who wish to have children post cervical cancer and treatment (Plante et al., 2004; 2005). This preservation of fertility in trachelectomy is a result of leaving the patient's uterus intact while removing the cervix, parametrium and upper one third of the vagina. With the uterus intact, the patients are capable of conceiving multiple births post-procedure (Bernardini et al., 2003, Plante et al., 2004; 2005), an option that was not present in the past for women after radical hysterectomy.

The few dozen studies done looking at the outcomes of trachelectomy have mainly focused on medical outcomes such as fertility and cancer cure and recurrence. The findings show there is a 70-72% success rate in women who try to conceive post-trachelectomy (Boss et al., 2005, Plante et al., 2005). If a patient is eligible for a trachelectomy procedure, according to the criteria (Sonoda et al., 2004), recurrence-free survival is excellent at 95% (Plante et al., 2004).

With such improvements in the identification and cure of cervical cancer and the use of fertility-sparing techniques, there has been an increase in the number of young patients in remission, raising a number of quality of life issues. Sexual health is recognized as an integral aspect of quality of life during survivorship and is increasingly receiving research and clinical attention (Juraskova et al., 2003; Wenzel et al., 2002). In the studies done on trachelectomy we find that there are a handful of women who, prior to the operation, wish to conceive a child, but post-operation lose this desire and do not try to conceive (Boss et al., 2005, Plante et al., 2005), but no further studies have been done in this area as to the reasons why. Although the studies have been very beneficial for medical information none of the studies examining the efficacy of trachelectomy have studied the impact on sexual health or quality of life. On the other hand, research on the effects of radical hysterectomy in women with cervical cancer finds approximately half of women experience negative sexual side-effects such as significantly more lubrication difficulties, reduced vaginal length and elasticity, and marked distress (Bergmark et al., 1999). Also distressing to 36% of the women in this group is the absence of genital swelling in more than half of their sexual encounters, despite no changes in sexual frequency or orgasmic experience (Bergmark et al., 1999). When a vaginal photoplethysmograph was used to document changes in genital blood flow (an indirect measure of sexual arousal), women with radical hysterectomy had more impairment in blood flow responses than either a control group or a simple hysterectomy group, suggesting involvement of autonomic nerves (Maas et al., 2002).

Given that women, together with their partners and oncologists, may find themselves in a position of selecting one procedure over another, it seems important to better understand the relative effects of these procedures on intimate life and sexual health. The objective of this study, therefore, is to compare radical hysterectomy with trachelectomy in the effects on intimacy, sexual health, and mood immediately before, 1 month after, and 6 months after surgery.

This study will help to identify patterns and outcomes on these aspects of quality of life in hopes of better informing women of the potential outcomes of their procedures. Cervical cancer and treatment are life-altering events; therefore it is desirable to identify and hopefully reduce any negative psychological and physical sequelae of treatment. We want to ensure that problems related to post-cervical cancer are diminished so that the survivor's quality of life can be maintained at an acceptable level, allowing the patients to continue living a fulfilling life, uninhibited by sexual and emotional distress.

Study Type

Observational

Enrollment (Actual)

33

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

Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1M9
    - British Columbia Cancer Agency

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

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women diagnosed with cervical or endometrial cancer

Description

Inclusion Criteria:

Women who have a diagnosis of cervical cancer
Women who are scheduled for either a radical hysterectomy or radical trachelectomy at the British Columbia Cancer Agency - Vancouver Cancer Centre
Proficient in English

Exclusion Criteria:

No woman who meets the inclusion criteria will be excluded from participating.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

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.

General Publications

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, 2006

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 16, 2006

First Submitted That Met QC Criteria