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Cervical or Endometrial Cancer and Sexual Health Study

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00134316
First received: August 22, 2005
Last updated: February 28, 2011
Last verified: February 2011

August 22, 2005
February 28, 2011
August 2005
November 2009   (final data collection date for primary outcome measure)
Upon completion of data analysis, establishment of the efficacy of a psychoeducational intervention (PED) in a sample of cervical or endometrial cancer survivors with sexual arousal disorder will be determined. [ Time Frame: upon completion of data collection ] [ Designated as safety issue: No ]
  • Phase 2: Upon completion of data analysis establishment of the efficacy of a psychoeducational intervention (PED)in a sample of cervical or endometrial cancer survivors with sexual Arousal Disorder will be determined.
  • Phase 1: upon completion of data analysis the lowest effective dose of sildenafil (Viagra)will be determined for use in Phase 2.
  • Data analysis will also show if there is added benefit of combining PED with sildenafil.
Complete list of historical versions of study NCT00134316 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Cervical or Endometrial Cancer and Sexual Health Study
Cervical or Endometrial Cancer and Sexual Health Study

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sexual Dysfunctions, Psychological
Behavioral: psychoeducational intervention
three 75 minute long individual psychoeducational sessions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
June 2010
November 2009   (final data collection date for primary outcome measure)

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
Female
19 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00134316
UBC-SH-CECSH.P1&2-20R91396, CIHR-PG#20R91396
No
Dr. Lori Brotto, University of British Columbia
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Rosemary Basson, FCRP (UK) University of British Columbia
University of British Columbia
February 2011

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