Sexual Functioning in Cervical Cancer Survivors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-09-10

Study Completion Date

2018-06-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Patient Satisfaction & Quality Of Life in Patients With Cervical Cancer

NCT00473798

Psychosocial Cervical Cancer

COMPLETED

Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection

NCT00508170

Head and Neck Cancer Oropharyngeal Cancer Human Papillomavirus Infection

COMPLETED

Use of Social Networking to Survey Women With Small and Large Cell Carcinomas of the Cervix

NCT01606293

Cervical Cancer

UNKNOWN

Vaginal Changes and Sexual Function in Patients With Cervical Cancer

NCT00053261

Cervical Cancer Sexuality and Reproductive Issues

COMPLETED

Development & Validation of Utilities for Health States Relevant to Cervical Cancer Patients

NCT00788216

Cervical Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Questionnaire

Intervention Type BEHAVIORAL

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

Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaire

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

Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Survey

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.