Clinical Trial: Cervical or Endometrial Cancer and Sexual Health Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Cervical or Endometrial Cancer and Sexual Health Study
Brief 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.
Detailed Summary:
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 cance
Sponsor: University of British Columbia
Current Primary Outcome: 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 ]
Original Primary Outcome:
- Phase 1: upon completion of data analysis the lowest effective dose of sildenafil (Viagra) will be determined for use in Phase 2
- 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.
- Data analysis will also show if there is added benefit of combining PED with sildenafil.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of British Columbia
Dates:
Date Received: August 22, 2005
Date Started: August 2005
Date Completion:
Last Updated: February 28, 2011
Last Verified: February 2011
