- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01159678
Online Psychoeducation for Sexual Dysfunction in Cancer Survivors (OPES)
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- UBC Sexual Health Lab
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
-
Study Plan
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:
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
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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