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Cervical or Endometrial Cancer and Sexual Health Study

28 febbraio 2011 aggiornato da: University of British Columbia

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

31

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 15 anni a 61 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: upon completion of data collection
upon completion of data collection

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Rosemary Basson, FCRP (UK), University of British Columbia

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2005

Completamento primario (Effettivo)

1 novembre 2009

Completamento dello studio (Effettivo)

1 giugno 2010

Date di iscrizione allo studio

Primo inviato

22 agosto 2005

Primo inviato che soddisfa i criteri di controllo qualità

22 agosto 2005

Primo Inserito (Stima)

24 agosto 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

2 marzo 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

28 febbraio 2011

Ultimo verificato

1 febbraio 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • UBC-SH-CECSH.P1&2-20R91396
  • CIHR-PG#20R91396

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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