Sexual Functioning in Cervical Cancer Survivors

Cervical Cancer Clinical Trial

Official title:

Sexual Functioning and Quality of Life in Women With Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00522223
• Other study ID #: ID02-376
• Secondary ID: 1R03CA097869-11R
• Status: Completed
• Start date: September 10, 2002
• Est. completion date: June 8, 2018

Study information

• Verified date: July 2018
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objectives:

Primary Objectives:

To assess the entire range of sexual functioning (desire, arousal, orgasmic capacity, dyspareunia, and sexual satisfaction) over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer; To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.

Secondary Objectives:

Describe vaginal changes objectively via measurement of vaginal length. Demonstrate reliability of the vaginal length instrument and its applicability to future studies.

Description:

There are two parts to this study. The first part is called a "feasibility study" and will include 20 women who have been treated for cervix cancer in the past. These women will be asked to fill out questionnaires to evaluate their quality of life and sexual functioning. The questionnaires will only be completed once. The questionnaires will be filled out during routine clinic visits.

If the feasibility study is successful (if the majority of the 20 women are able to complete the questionnaires), the second part of the study will be performed with a larger number of women who have been diagnosed with cervix cancer but who have not yet begun treatment. Patients who participate in this part of the study will also be asked to fill out the questionnaires described above.

Participants who are treated with radiation therapy will be asked to complete questionnaires 5 times: before radiation treatment starts, at the time of the first ALTO, and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends.

Participants who undergo a radical hysterectomy will be asked to complete questionnaires and have a vaginal measurement 4 times: before surgery and 1 month, 4 months and 7 months after treatment ends. Vaginal measurements will only be done 4 times: at the time of first ALTO, and 1 month, 4 months and 7 months after treatment ends.

The questionnaires take about 20 minutes to complete. The vaginal measurement is done by a doctor and takes less than a minute to complete.

This is an investigational study. About 165 patients will take part in this multicenter study. About 135 patients will be enrolled at M. D. Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: June 8, 2018
• Est. primary completion date: June 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Eligibility criteria for 20 women in the pilot study (see Treatment Plan for details) of feasibility include: a) History of cervical cancer (within 3 months to 5 years of diagnosis); b) English or Spanish-speaking; and c) Ability to give informed consent.

2. Eligibility criteria for the main study: a) New diagnosis of local or locally advanced cervical cancer; b) English or Spanish-speaking; and c) Ability to give informed consent.

Exclusion Criteria:

1. Patients who are illiterate.

2. Patients who have undergone an exenteration.

3. Patients who do not speak English or Spanish.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• Questionnaire
Participants who are treated with radiation therapy: Questionnaires 5 times. Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.		7 Years

External Links

•   University of Texas MD Anderson Cancer Center Website