NCT00134316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

March 2, 2011

Status Verified

February 1, 2011

Enrollment Period

4.3 years

First QC Date

August 22, 2005

Last Update Submit

February 28, 2011

Conditions

Sexual Dysfunctions, Psychological

Keywords

sexual dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    upon completion of data collection

Interventions

psychoeducational interventionBEHAVIORAL

three 75 minute long individual psychoeducational sessions

Eligibility Criteria

Age19 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Related Publications (13)

  • Butler L, Banfield V, Sveinson T, Allen K. Conceptualizing sexual health in cancer care. West J Nurs Res. 1998 Dec;20(6):683-99; discussion 700-5. doi: 10.1177/019394599802000603.

    PMID: 9842287BACKGROUND

  • Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical and simple hysterectomy: a quantitative study of nerve types in the uterine supporting ligaments. J Soc Gynecol Investig. 2002 Jan-Feb;9(1):47-56. doi: 10.1016/s1071-5576(01)00145-9.

    PMID: 11839509BACKGROUND

  • Grumann M, Robertson R, Hacker NF, Sommer G. Sexual functioning in patients following radical hysterectomy for stage IB cancer of the cervix. Int J Gynecol Cancer. 2001 Sep-Oct;11(5):372-80. doi: 10.1046/j.1525-1438.2001.01051.x.

    PMID: 11737468BACKGROUND

  • Juraskova I, Butow P, Robertson R, Sharpe L, McLeod C, Hacker N. Post-treatment sexual adjustment following cervical and endometrial cancer: a qualitative insight. Psychooncology. 2003 Apr-May;12(3):267-79. doi: 10.1002/pon.639.

    PMID: 12673810BACKGROUND

  • Kylstra WA, Leenhouts GH, Everaerd W, Panneman MJ, Hahn DE, Weijmar Schultz WC, Van De Wiel HB, Heintz AP. Sexual outcomes following treatment for early stage gynecological cancer: a prospective multicenter study. Int J Gynecol Cancer. 1999 Sep;9(5):387-395. doi: 10.1046/j.1525-1438.1999.99052.x.

    PMID: 11240799BACKGROUND

  • Robinson JW, Faris PD, Scott CB. Psychoeducational group increases vaginal dilation for younger women and reduces sexual fears for women of all ages with gynecological carcinoma treated with radiotherapy. Int J Radiat Oncol Biol Phys. 1999 Jun 1;44(3):497-506. doi: 10.1016/s0360-3016(99)00048-6.

    PMID: 10348277BACKGROUND

  • Wenzel LB, Donnelly JP, Fowler JM, Habbal R, Taylor TH, Aziz N, Cella D. Resilience, reflection, and residual stress in ovarian cancer survivorship: a gynecologic oncology group study. Psychooncology. 2002 Mar-Apr;11(2):142-53. doi: 10.1002/pon.567.

    PMID: 11921330BACKGROUND

  • Andersen BL, Woods XA, Copeland LJ. Sexual self-schema and sexual morbidity among gynecologic cancer survivors. J Consult Clin Psychol. 1997 Apr;65(2):221-9. doi: 10.1037//0022-006x.65.2.221.

    PMID: 9086685BACKGROUND

  • Anderson BJ, Wolf FM. Chronic physical illness and sexual behavior: psychological issues. J Consult Clin Psychol. 1986 Apr;54(2):168-75. doi: 10.1037//0022-006x.54.2.168. No abstract available.

    PMID: 3700803BACKGROUND

  • Butler-Manuel SA, Buttery LD, A'Hern RP, Polak JM, Barton DP. Pelvic nerve plexus trauma at radical hysterectomy and simple hysterectomy: the nerve content of the uterine supporting ligaments. Cancer. 2000 Aug 15;89(4):834-41. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-7.

    PMID: 10951347BACKGROUND

  • Capone MA, Good RS, Westie KS, Jacobson AF. Psychosocial rehabilitation of gynecologic oncology patients. Arch Phys Med Rehabil. 1980 Mar;61(3):128-32.

    PMID: 7369850BACKGROUND

  • Leenhouts GH, Kylstra WA, Everaerd W, Hahn DE, Schultz WC, van de Wiel HB, Heintz AP. Sexual outcomes following treatment for early-stage gynecological cancer: a prospective and cross-sectional multi-center study. J Psychosom Obstet Gynaecol. 2002 Jun;23(2):123-32. doi: 10.3109/01674820209042794.

    PMID: 12189897BACKGROUND

  • Basson R, Brotto LA. Sexual psychophysiology and effects of sildenafil citrate in oestrogenised women with acquired genital arousal disorder and impaired orgasm: a randomised controlled trial. BJOG. 2003 Nov;110(11):1014-24.

    PMID: 14592587BACKGROUND

Related Links

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalSexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Mental DisordersGenital DiseasesUrogenital Diseases

Study Officials

  • Rosemary Basson, FCRP (UK)

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

August 1, 2005

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

March 2, 2011

Record last verified: 2011-02

Locations

CA(1)