Advanced Ovarian Cancer and Sexuality Phase 1 (ANOVA1)

May 30, 2017 updated by: Lori Brotto, University of British Columbia

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5M 1M9
        • UBC Sexual Health Lab, Vancouver Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • UBC Sexual Health Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

women diagnosed with advanced ovarian cancer

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Lori A Brotto, PhD, UBC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

June 18, 2007

First Submitted That Met QC Criteria

June 19, 2007

First Posted (Estimate)

June 20, 2007

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H06-03235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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