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Completed

NCT Number: NCT01159678

Online Psychoeducation for Sexual Dysfunction in Cancer Survivors

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UBC Sexual Health Lab

Vancouver, British Columbia, V5Z 1M9, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged 19-70,
  • 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,
  • received treatment in the past 5 years
  • currently in a relationship
  • currently experiencing sexual dysfunction, and
  • able to participate (both physically and emotionally) in completion of an online psychoeducational treatment.

Exclusion criteria

-

Treatment and study plan

online psychoeducation

Behavioral

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:

  • Important of sexuality to quality of life. & Definitions of sexual desire and arousal.
  • Consideration of the predisposing, precipitating, and perpetuating factors in his/her sexual difficulties.
  • Sexual beliefs.
  • Mindfulness.
  • Genital anatomy and physiology.
  • Body Image.
  • Relationship satisfaction and communication.
  • Body-oriented mindfulness exercises (focusing and self-observation).
  • Using Thought records.
  • Mindfulness and the thought stream.
  • Sexual aids to boost arousal.
  • 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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: OPES

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 9, 2010
Registry last updated
Jun 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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