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Online Psychoeducation for Sexual Dysfunction in Cancer Survivors (OPES)

This study is currently recruiting participants.
Verified October 2012 by University of British Columbia
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01159678
First received: June 22, 2010
Last updated: October 23, 2012
Last verified: October 2012
History of Changes
  Purpose

The purpose of this study is to test an online psychoeducational intervention for men and women with sexual difficulties after surgery for colorectal (men and women) or gynecological (women only) cancer. A psychoeducational intervention is a brief, educational treatment that encourages participants to also pay attention to, and modify, their thoughts, feelings, and behaviour.


Condition Intervention
Sexual Dysfunction
 Behavioral: online psychoeducation

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Online Psychoeducation for Sexual Dysfunction in Cancer Survivors

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Sexual distress [ Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment ] [ Designated as safety issue: No ]
    measured by self report questionnaires


Secondary Outcome Measures:
  • Sexual function [ Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment ] [ Designated as safety issue: No ]
    measured by self-report questionnaires


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: online psychoeducation Behavioral: online psychoeducation

The online psychoeducation contains 12 modules which will be administered once per week over the course of three months. The content of each module is as follows:

  1. Important of sexuality to quality of life. & Definitions of sexual desire and arousal.
  2. Consideration of the predisposing, precipitating, and perpetuating factors in his/her sexual difficulties.
  3. Sexual beliefs.
  4. Mindfulness.
  5. Genital anatomy and physiology.
  6. Body Image.
  7. Relationship satisfaction and communication.
  8. Body-oriented mindfulness exercises (focusing and self-observation).
  9. Using Thought records.
  10. Mindfulness and the thought stream.
  11. Sexual aids to boost arousal.
  12. Moving on.

In addition to these weekly modules, all participants will have access to a moderated and password-protected bulletin board to which participants can post questions and the PI will respond.

Detailed Description:

Experiencing a diagnosis of cancer may dramatically alter the way a person feels about themselves, their body, and their significant relationships at sexual and intimate levels1. Cancer and its treatments affect the physiological, psychological, and sociological realms of a survivor's life and his/her ability to experience sexual health. Sexual health is recognized as an integral aspect of quality of life (QOL) during cancer and is increasingly receiving research and clinical attention. Sexual changes following the treatment of gynaecologic (i.e.: ovarian, endometrial, cervical) and colorectal cancers are common though often not discussed. Moreover, cancer survivors express dissatisfaction that sexual concerns, and treatment of them, are not discussed in the context of their cancer care. Oncologists frequently are faced with patients inquiring about sexual changes with cancer treatment, but are usually not equipped with accurate and comprehensive data on the precise sexual symptoms to expect or where to refer patients with sexual concerns.

The aims of the study are to assess the efficacy of a 12-module online psychoeducational intervention for sexual health (OPES) on (1) the primary endpoint of sexual distress in male and female cancer survivors with sexual problems; (2) the secondary sexuality-related endpoints of sexual desire, arousal (women) or erection (men), orgasm, and sexual pain; (3) on mood, relationship satisfaction, and quality of life; and (4) to assess gender differences in the proportion of survivors improved on sexual distress.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. aged 19-70,
  2. treatment of gynaecologic or colorectal cancer by one of the surgical oncologists of the gynaecology or colorectal teams of the BC Cancer Agency centres or satellite sites,
  3. received treatment in the past 5 years
  4. currently in a relationship
  5. currently experiencing sexual dysfunction, and
  6. able to participate (both physically and emotionally) in completion of an online psychoeducational treatment.

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159678

Contacts
Contact: Yvonne Erskine, M.Ed 604-875-4111 ext 68901 yvonne.erskine@vch.ca

Locations
Canada, British Columbia
UBC Sexual Health Lab Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Yvonne Erskine, M.Ed     604-875-4111 ext 68901     yvonne.erskine@vch.ca    
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Lori Brotto, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01159678     History of Changes
Other Study ID Numbers: H10-01032
Study First Received: June 22, 2010
Last Updated: October 23, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013