Ovarian CancerANOVA1NCT00488202
Advanced Ovarian Cancer and Sexuality Phase 1
An observational study of Ovarian Cancer and Sexual Function, run by University of British Columbia at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years, women only
- Conditions the study is for
- Ovarian Cancer, Sexual Function
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- May 2007to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women diagnosed with advanced ovarian cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
UBC Sexual Health Lab, Vancouver Hospital
Vancouver, British Columbia, V5M 1M9
UBC Sexual Health Lab
Vancouver, British Columbia, V5Z 1M9
About this study
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
Read the 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.
- Conditions
- Ovarian Cancer, Sexual Function
- Keywords
- Advanced Ovarian Cancer, Sexual Function
- Medical subject headings
- Ovarian Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Brotto, University of British Columbia
- Investigators
- Lori A Brotto, PhD, Principal investigator, UBC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488202
- Sponsor's protocol ID
- H06-03235
- Acronym
- ANOVA1
- Status last verified
- May 2017
- First submitted
- 18 Jun 2007
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Ovarian Cancer and Sexuality Phase 1
- ClinicalTrials.gov ID
- NCT00488202
- Acronym / sponsor ID
- ANOVA1 / H06-03235
- Conditions
- Ovarian Cancer, Sexual Function
- Keywords
- Advanced Ovarian Cancer, Sexual Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women diagnosed with advanced ovarian cancer
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori A Brotto, PhD principal investigator
UBC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Sexual Function, run by University of British Columbia at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.