Online Psychoeducation for Sexual Dysfunction in Cancer Survivors (OPES)

June 11, 2015 updated by: Lori Brotto, University of British Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • UBC Sexual Health Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual distress
Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment
measured by self report questionnaires
Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sexual function
Time Frame: Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment
measured by self-report questionnaires
Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

April 1, 2014

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

July 8, 2010

First Posted (ESTIMATE)

July 9, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 15, 2015

Last Update Submitted That Met QC Criteria

June 11, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • H10-01032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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