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Sexual Functioning and Quality of Life in Women With Cervical Cancer


N/A
N/A
N/A
Open (Enrolling)
Female
Cervical Cancer

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Trial Information

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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To evaluate sexual functioning and the quality of life (QOL) in women with cervix cancer.

Outcome Time Frame:

7 Years

Safety Issue:

No

Principal Investigator

Diane C. Bodurka, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

ID02-376

NCT ID:

NCT00522223

Start Date:

September 2002

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Cervical Cancer
  • Cancer Survivors
  • Cervix Cancer
  • Sexual Functioning
  • Quality Of Life
  • Questionnaire
  • Radiation Therapy
  • Radical Hysterectomy
  • Uterine Cervical Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030