Sexual Functioning in Cervical Cancer Survivors

NCT00522223 | Completed

• 3 other identifiers: ID02-3761R03CA097869-11R03CA097869
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical Cancer; Cancer Survivors; Cervix Cancer; Sexual Functioning; Quality Of Life; Questionnaire; Radiation Therapy; Radical Hysterectomy

Outcome Measures

Primary Outcomes (1)

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

  7 Years

Study Arms (1)

Questionnaire

Questionnaire

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

Participants who are treated with radiation therapy: Questionnaires 5 times. Participants who undergo a radical hysterectomy: Questionnaires 4 times.

Also known as: Survey

Questionnaire

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with history of cervical cancer.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients who are illiterate.
• Patients who have undergone an exenteration.
• Patients who do not speak English or Spanish.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Diane C. Bodurka, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2007
• First Posted: August 29, 2007
• Study Start: September 10, 2002
• Primary Completion: June 8, 2018
• Study Completion: June 8, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)