Online Psychoeducation for Sexual Dysfunction in Cancer Survivors

Sexual Dysfunction Clinical Trial

— OPES  

Official title:

Online Psychoeducation for Sexual Dysfunction in Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159678
• Other study ID #: H10-01032
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: June 11, 2015
• Start date: October 2010
• Est. completion date: April 2014

Study information

• Verified date: June 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

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: 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.

Locations

Country	Name	City	State
Canada	UBC Sexual Health Lab	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual distress	measured by self report questionnaires	Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment	No
Secondary	Sexual function	measured by self-report questionnaires	Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment	No