NCT01159678

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2010

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 9, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 15, 2015

Status Verified

June 1, 2015

Enrollment Period

3 years

First QC Date

June 22, 2010

Last Update Submit

June 11, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sexual distress

    measured by self report questionnaires

    Questionnaires administered 1 week pre-treatment, 1 week post treatment and six months post treatment

Secondary Outcomes (1)

  • Sexual function

    Questionnaires administered 1 week pre-treatment, 1 week post- treatment and six months post treatment

Study Arms (1)

online psychoeducation

EXPERIMENTAL
Behavioral: online psychoeducation

Interventions

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.

online psychoeducation

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UBC Sexual Health Lab

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Lori Brotto, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 22, 2010

First Posted

July 9, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2013

Study Completion

April 1, 2014

Last Updated

June 15, 2015

Record last verified: 2015-06

Locations