Sexual Functioning and Quality of Life in Women With Cervical Cancer
FIRST PART: NO LONGER RECRUITING
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.
SECOND PART: RECRUITING
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.
Observational Model: Case-Only, Time Perspective: Prospective
To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.
Diane C. Bodurka, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|