Online Psychoeducation for Sexual Dysfunction in Cancer Survivors (OPES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159678
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : June 15, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Lori Brotto, University of British Columbia

Brief Summary:
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 or disease Intervention/treatment Phase
Sexual Dysfunction Behavioral: online psychoeducation Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Online Psychoeducation for Sexual Dysfunction in Cancer Survivors
Study Start Date : October 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Sexual distress [ Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment ]
    measured by self report questionnaires

Secondary Outcome Measures :
  1. Sexual function [ Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment ]
    measured by self-report questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01159678

Canada, British Columbia
UBC Sexual Health Lab
Vancouver, British Columbia, Canada, V5Z 1M9
Sponsors and Collaborators
University of British Columbia
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Lori Brotto, PhD University of British Columbia

Responsible Party: Lori Brotto, Associate Professor, University of British Columbia Identifier: NCT01159678     History of Changes
Other Study ID Numbers: H10-01032
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: June 15, 2015
Last Verified: June 2015