Clinical trial NCT00488202: Advanced Ovarian Cancer and Sexuality Phase 1
Official title: Advanced Ovarian Cancer and Sexuality Phase 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Sexual Function
Keywords: Advanced Ovarian Cancer
Sexual Function
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2007-06-20
Enrollment: 26
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women diagnosed with advanced ovarian cancer

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Sexual Health Lab, Vancouver Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: UBC Sexual Health Lab
state: British Columbia
Study officials:
affiliation: UBC
name: Lori A Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: