Cervical Cancer Clinical Trial
Official title:
Sexual Functioning and Quality of Life in Women With Cervical Cancer
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.
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.
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