Relevance of CONSORT reporting criteria for research on eHealth interventions.
Timothy B Baker, David H Gustafson, Bret Shaw...
https://pubmed.ncbi.nlm.nih.gov/20843621Actively Recruiting
Phase Not Applicable
Age: 19Years +
FEMALE
ID06619769
eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Led by University of British Columbia · Updated on 2025-09-25
60
Participants Needed
1
Research Sites
22 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
X
Xavier University of Louisiana.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Sexual health is an important part of treatment and recovery for women with gynecologic cancers. This research evaluates how well an adapted online program called eSense-Cancer meets the sexual health needs of gynecologic cancer survivors. The study aims to test the effectiveness of this platform, which could improve access to care for survivors facing barriers such as geographic location, ethnicity, sexual orientation, socioeconomic status, or gender identity. Participants will be randomly assigned to one of four groups: cognitive-behavioral therapy (CBT) with or without navigator support, and mindfulness-based therapy (MBT) with or without navigator support. Those in navigator groups will have an initial online meeting with a trained psychology student who will provide guidance throughout the 8 to 16-week program. Participants complete one module weekly or biweekly, with exercises and questionnaires to assess usability and satisfaction. During the study, participants will fill out questionnaires before starting, after a 4-week waiting period, and at the end of treatment to measure sexual distress and function. Researchers will also track engagement through website activity and homework completion. Navigator interactions will be monitored for adherence to study guidelines. Women must keep medications affecting sexual health stable and avoid internet research on sexual dysfunction during the trial. The study includes ongoing evaluation of acceptability, practicality, and preliminary clinical outcomes of the eSense-Cancer program.
CONDITIONS
Brief Title
eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Who Can Participate
Age: 19Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Self-report a current or history of gynecologic cancer of any subtype
- Self-report symptoms of sexual difficulties and score greater than 11 on the Female Sexual Distress Scale-Revised
- Fluent in English
- Have reliable internet access and basic competency in using online platforms
- Available for 8 to 16 weeks to complete eSense modules and questionnaires
- Any gender
You will not qualify if you...
- Visual impairments or disabilities that interfere with reading and interacting with online materials
- Poorly managed anxiety or mood disorder causing significant life interference
- Currently in active treatment for cancer, including radiation, chemotherapy, or planned surgeries
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online consent and baseline questionnaires)
Run-in Period
Duration - 4 weeks
Participants complete baseline questionnaires and undergo a 4-week waiting period before starting treatment.
2 online questionnaire assessments (before and after waiting period)
Treatment
Duration - 8 to 16 weeks
Participants receive one of four online behavioral interventions (CBT or MBT), with or without navigator support, completing 8 modules over 8 to 16 weeks. Navigator-supported participants have brief weekly meetings.
Weekly or biweekly online module completion with 1 to 8 navigator support meetings (for those assigned navigator)
Follow-up
Duration - 1 to 2 weeks
Participants complete post-treatment questionnaires assessing treatment satisfaction, usability, and clinical outcomes.
1 online post-treatment questionnaire
Trial Site Locations
Total: 1 location
1
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
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Research Team
N
Nisha Marshall, MSc
K
Kira McNamee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
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Published Research Related To This Trial
Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder.
Leonard Derogatis, Anita Clayton, Diane Lewis-D'Agostino...
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A E Kazdin
https://pubmed.ncbi.nlm.nih.gov/7380752Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder.
Lori A Brotto, Kyle R Stephenson, Natasha Zippan
https://pubmed.ncbi.nlm.nih.gov/35035598