Sexual Functioning in Cervical Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00522223
First received: August 28, 2007
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

Primary Objectives:

  1. 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;
  2. To assess general cancer-related QOL over the course of treatment and early follow-up in patients with local and locally advanced cervical cancer;
  3. To characterize the relationship between sexual dysfunction and overall cancer-related QOL over time; and
  4. To identify factors that may predict better sexual function outcomes in patients treated for cervical cancer.

Secondary Objectives:

  1. Describe vaginal changes objectively via measurement of vaginal length.
  2. Demonstrate reliability of the vaginal length instrument and its applicability to future studies.

Condition Intervention
Cervical Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sexual Functioning and Quality of Life in Women With Cervical Cancer

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer. [ Time Frame: 7 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: September 2002
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Questionnaire
Behavioral: Questionnaire

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

Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Other Name: Survey

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women with history of cervical cancer.

Criteria

Inclusion Criteria:

  1. Eligibility criteria for 20 women in the pilot study (see Treatment Plan for details) of feasibility include:

    • History of cervical cancer (within 3 months to 5 years of diagnosis)
    • English or Spanish-speaking
    • Ability to give informed consent
  2. Eligibility criteria for the main study:

    • New diagnosis of local or locally advanced cervical cancer
    • English or Spanish-speaking
    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522223

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Diane C. Bodurka, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00522223     History of Changes
Other Study ID Numbers: ID02-376
Study First Received: August 28, 2007
Last Updated: September 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Cervical Cancer
Cancer Survivors
Cervix Cancer
Sexual Functioning
Quality Of Life
Questionnaire
Radiation Therapy
Radical Hysterectomy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 15, 2014