Clinical trial NCT00522223: Sexual Functioning in Cervical Cancer Survivors
Official title: Sexual Functioning and Quality of Life in Women With Cervical Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Cancer Survivors
Cervix Cancer
Sexual Functioning
Quality Of Life
Questionnaire
Radiation Therapy
Radical Hysterectomy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-29
Enrollment: 111
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with history of cervical cancer.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.
timeFrame: 7 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Diane C. Bodurka, MD
role: PRINCIPAL_INVESTIGATOR
References: