Sexual Functioning in Cervical Cancer Survivors

July 13, 2018 updated by: M.D. Anderson Cancer Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with history of cervical cancer.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire
Behavioral: Questionnaire

Participants who are treated with radiation therapy: Questionnaires 5 times.

Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.
Time Frame: 7 Years
7 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Diane C. Bodurka, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2002

Primary Completion (Actual)

June 8, 2018

Study Completion (Actual)

June 8, 2018

Study Registration Dates

First Submitted

August 28, 2007

First Submitted That Met QC Criteria

August 28, 2007

First Posted (Estimate)

August 29, 2007

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID02-376
  • 1R03CA097869-1 (Other Identifier: NCI)
  • 1R03CA097869 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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