Clinical trial NCT01159678: Online Psychoeducation for Sexual Dysfunction in Cancer Survivors
Official title: Online Psychoeducation for Sexual Dysfunction in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2010-07-09
Enrollment: 112
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Sexual distress
timeFrame: Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment
Secondary outcomes:
measure: Sexual function
timeFrame: Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: UBC Sexual Health Lab
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori Brotto, PhD
role: PRINCIPAL_INVESTIGATOR
References: