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Advanced Ovarian Cancer and Sexuality Phase 1 (ANOVA1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00488202
First received: June 18, 2007
Last updated: April 16, 2013
Last verified: April 2013
History of Changes

June 18, 2007
April 16, 2013
May 2007
August 2011   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00488202 on ClinicalTrials.gov Archive Site
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Advanced Ovarian Cancer and Sexuality Phase 1
Advanced Ovarian Cancer and Sexuality Phase 1

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

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.
Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

women diagnosed with advanced ovarian cancer
  • Ovarian Cancer
  • Sexual Function
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Female
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00488202
H06-03235
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Lori A Brotto, PhD UBC
University of British Columbia
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP