Advanced Ovarian Cancer and Sexuality Phase 1

NCT ID: NCT00488202

Last Updated: 2017-06-01

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

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2011-08-31

Brief Summary

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

Women with Advanced Ovarian Cancer (AOC) suffer from severe sexual side effects from treatment. The prevalence of the sexual issues is not known.

The degree to which these sexual side effects is affected by treatment is also not known, as the literature in this area focuses on post-treatment analysis.

Specific Aim #1 (Quantitative Phase): To determine the prevalence and types of sexual difficulties using self-report questionnaires in women about to receive treatment for Stage III or IV Ovarian Cancer at the BCCA and over time, and to correlate these symptoms with degree of cancer symptoms, well-being, depressive symptoms, and relationship satisfaction

Detailed Description

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

Hypothesis 1a: Compared to baseline pre-treatment data, and to existing data for women with early-stage gynaecologic cancer, rates of sexual difficulties will be significantly higher and frequency of sexual intercourse will be significantly lower in women with advanced ovarian cancer. We hypothesize that difficulties specifically in the domains of sexual desire, sexual distress, and genital pain will be the most common types of sexual dysfunction to characterize women with advanced ovarian cancer.

Hypothesis 1b: We hypothesize that the degree of sexual symptoms will be significantly greater at 3 months and 10 months post-treatment than compared to pre-treatment, and that sexual difficulties may be significantly greater at 3 months post-treatment than at 10-months post-treatment.

Hypothesis 1c: We hypothesize that degree of sexual difficulty and sexual distress will be significantly correlated with (a) overall well-being; (b) depressive symptoms; and (c) relationship satisfaction.

Hypothesis 1d: As an exploratory analysis, we will investigate the relationship of ovarian cancer-related variables (i.e., type of treatment, duration of treatment, number of medications), and demographic variables (i.e., age, relationship duration, education) on each of the hypotheses in 1a - 1c.

Conditions

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

Ovarian Cancer Sexual Function

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

* Women with Advanced Ovarian Cancer (AOC) who have not received treatment yet, but who are seeking treatment at the BC Cancer Agency.
* Women must be able to understand English enough to fill out the questionnaire packages.
* Mastery of written English is required. No translation services will be available for this study.

Exclusion Criteria

* Anyone without an AOC diagnosis, who are not seeking treatment at BCCA, or who cannot understand enough English to complete the questionnaires will be excluded.
* Those who do not have a mastery of written English are excluded.
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Lori Brotto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lori A Brotto, PhD

Role: PRINCIPAL_INVESTIGATOR

UBC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UBC Sexual Health Lab, Vancouver Hospital

Vancouver, British Columbia, Canada

Site Status

UBC Sexual Health Lab

Vancouver, British Columbia, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

H06-03235

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Why do Oral Contraceptives Prevent Ovarian Cancer?
NCT02155777 COMPLETED EARLY_PHASE1