Sexual Functioning in Cervical Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT00522223|
Recruitment Status : Active, not recruiting
First Posted : August 29, 2007
Last Update Posted : October 25, 2017
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.
Describe vaginal changes objectively via measurement of vaginal length. Demonstrate reliability of the vaginal length instrument and its applicability to future studies.
|Condition or disease||Intervention/treatment|
|Cervical Cancer||Behavioral: Questionnaire|
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.
|Study Type :||Observational|
|Estimated Enrollment :||165 participants|
|Official Title:||Sexual Functioning and Quality of Life in Women With Cervical Cancer|
|Actual Study Start Date :||September 2002|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Participants who are treated with radiation therapy: Questionnaires 5 times.
Participants who undergo a radical hysterectomy: Questionnaires 4 times.
Other Name: Survey
- To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer. [ Time Frame: 7 Years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522223
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Diane C. Bodurka, MD||M.D. Anderson Cancer Center|