Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134316
Status:
COMPLETED
Last Update Posted:
2011-03-02
First Post:
2005-08-22
Brief Title:
Cervical or Endometrial Cancer and Sexual Health Study
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Cervical or Endometrial Cancer and Sexual Health Study
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Description:
Whereas relatively more research and therapy options exist for physical treatments of sexual dysfunction in women with a history of cervical cancer eg 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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR-PG20R91396 | None | None | None |