Home | All trials

[RDF data]
Trial NCT00134316

Resource URI: http://static.linkedct.org/resource/trials/NCT00134316
PropertyValue
linkedct:brief_title Cervical or Endometrial Cancer and Sexual Health Study
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/12038>
linkedct:criteria Inclusion Criteria: - Diagnosis of cervical or endometrial cancer, in remission for at least 1 year - Treatment by hysterectomy at least one year earlier - Diagnosis of female sexual arousal disorder (FSAD) according to DSM-IV-TR criteria with new onset after the hysterectomy - Currently involved in a relationship Exclusion Criteria: - Treatment by either radiation or chemotherapy alone - Current diagnosis of primary hypoactive sexual desire disorder - or in other words, if complaints of sexual desire are present, they must be less distressing than the sexual arousal complaints. - Unstable psychopathology and Beck Depression Inventory scores greater than 19 - Lack of sexual experience - Current use of antidepressants or other medication with known sexual side effects - Those with a physical condition that would impede participation in the psychophysiological assessment
linkedct:description Whereas relatively more research and therapy options exist for physical treatments of sexual dysfunction in women with a history of cervical cancer (e.g. hormone replacement, surgery; Denton & Maher, 2003), there is some evidence that psychological interventions have positive effects on sexuality. For example, a brief psychoeducational program for women with early-stage cervical cancer resulted in significant improvements in the frequency of coital activity (Capone et al., 1980), and enhanced compliance with sexual rehabilitation, reduced fear about intercourse and improved sexual knowledge compared to a control condition (Robinson et al., 1999). Unfortunately, neither study targeted nor assessed sexual arousal or genital sensations - symptoms documented to be most problematic and distressing in this group of women. There is also evidence that providing a venue for women to receive education and discuss sexual concerns following cervical cancer is therapeutic as it might encourage women to be more aware of their sexual rehabilitation and capacity for change, thus evoking a more active coping style (Leenhouts et al., 2002). Taken together, these studies suggest that psychoeducational interventions are feasible and significantly improve general domains of sexual function, such as sexual frequency and knowledge, in cervical cancer survivors. Although directly targeting psychological constructs such as thoughts, affect, and behaviour, psychological treatments can also evoke physiological change. In cervical cancer-related sexual dysfunction where the psychological and physical contributors of impairment are difficult to tease apart, a psychoeducational intervention that addresses both etiological domains is essential. We have recently developed a 3-session psychoeducational intervention designed to address both the physical and psychological consequences of cervical cancer on sexual arousal. The sexual arousal concerns reported by this group of women fit the criteria for Female Sexual Arousal Disorder (FSAD), defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revised (DSM-IV-TR) as "persistent or recurrent inability to attain, or to maintain until completion of the sexual activity, an adequate lubrication-swelling response of sexual excitement" where "the disturbance causes marked distress or interpersonal difficulty" (American Psychiatric Association, 2000). A proportion of these women also experience new onset difficulties becoming subjectively sexually aroused, likely as a direct result of the genital arousal difficulties, but also due to the impact of cancer and hysterectomy on psychological function. Despite the wide prevalence of such subjective arousal concerns, this is not a diagnostic category in the DSM-IV-TR. However, the International Consultation on Sexual Dysfunctions, in collaboration with the World Health Organization, has suggested that "Subjective Sexual Arousal Disorder" be recognized as a valid concern (Basson et al., 2003). Evidence-based treatments for FSAD related to genital or subjective arousal difficulties do not exist, and persisting distress due to untreated sexual dysfunction can compromise mental and physical health. The contents of our psychoeducational intervention were based on: - empirically supported techniques in other areas of female sexual dysfunction (e.g., sensate focus, challenging of maladaptive cognitions and sexual myths); - discussions with gynecological oncologists at the University of Washington who are usually the first-line recipients of such sexual complaints; and - pilot interviews conducted with 18 cervical and endometrial cancer survivors to date. The intervention focuses primarily on sexual arousal, both genital and subjective, and secondarily on the interaction between cervical cancer and hysterectomy with relationship satisfaction, body image, and beliefs about health.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 65 Years
linkedct:eligibility_minimum_age 19 Years
linkedct:end_date May 2009
linkedct:enrollment 66 (xsd:int)
linkedct:firstreceived_date August 22, 2005
linkedct:has_dmc No
linkedct:id NCT00134316
linkedct:intervention <http://static.linkedct.org/resource/intervention/62561>
rdfs:label Trial NCT00134316
linkedct:lastchanged_date August 21, 2009
linkedct:lead_sponsor_agency University of British Columbia
linkedct:location <http://static.linkedct.org/resource/location/22936>
linkedct:nct_id NCT00134316
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Cervical or Endometrial Cancer and Sexual Health Study
linkedct:org_study_id UBC-SH-CECSH.P1&2-20R91396
linkedct:overall_contact_email lori.brotto@vch.ca
linkedct:overall_contact_last_name Lori A Brotto, PhD
linkedct:overall_contact_phone 604 875 4111
linkedct:overall_contact_phone_ext 68898
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/52043>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/415>
foaf:page <http://clinicaltrials.gov/show/NCT00134316>
linkedct:phase N/A
linkedct:primary_completion_date November 2008
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/76281>
linkedct:reference <http://static.linkedct.org/resource/reference/11946>
linkedct:reference <http://static.linkedct.org/resource/reference/12582>
linkedct:reference <http://static.linkedct.org/resource/reference/13047>
linkedct:reference <http://static.linkedct.org/resource/reference/14483>
linkedct:reference <http://static.linkedct.org/resource/reference/16897>
linkedct:reference <http://static.linkedct.org/resource/reference/19828>
linkedct:reference <http://static.linkedct.org/resource/reference/41561>
linkedct:reference <http://static.linkedct.org/resource/reference/44626>
linkedct:reference <http://static.linkedct.org/resource/reference/4581>
linkedct:reference <http://static.linkedct.org/resource/reference/51872>
linkedct:reference <http://static.linkedct.org/resource/reference/55578>
linkedct:reference <http://static.linkedct.org/resource/reference/7899>
linkedct:reference <http://static.linkedct.org/resource/reference/9497>
linkedct:secondary_id CIHR-PG#20R91396
linkedct:source University of British Columbia
linkedct:start_date August 2005
linkedct:study_design Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary Aim #1. To investigate the efficacy of the psychoeducational intervention (PED) on sexual arousal. H1: Compared to a control group and to baseline, PED will result in significant improvement in: - self-reported subjective sexual arousal; - self-reported genital sensitivity; - psychophysiological sexual arousal. Aim #2. To investigate the efficacy of the PED on self-reported orgasm, sexual desire, distress, and relationship satisfaction. H2: Compared to a control group and to baseline, PED will result in significant improvement in self-reported orgasmic experience, sexual desire, sexual distress, and relationship satisfaction. Aim #3. To investigate the efficacy of the PED on depressive symptoms and quality of life. H3: Compared to a control group and to baseline, PED will result in significant improvement in self-reported depressive symptoms and quality of life.
rdf:type linkedct:trials
linkedct:verification_date August 2009