About this trial
Sexual health is a vital component of gynecologic cancer treatment and survivorship. Unfortunately, most gynecologic cancer survivors lack sufficient information about the impact of cancer on sexual health and treatment opportunities. This research aims to assess how well an adapted online health intervention meets the sexual health needs of gynecologic cancer survivors and to test the efficacy of the new platform. If successful, eSense-Cancer may increase access to treatment for gynecologic cancer survivors, including those living in remote areas or facing other accessibility barriers. It may also fill healthcare gaps for survivors of varying ethnicity, sexual orientation, socioeconomic status, and gender.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
self-report a current or history of gynecologic cancer of any subtype
self-report symptoms of sexual difficulties and score of greater than 11 on the Female Sexual Distress Scale-Revised
are fluent in English (eSense content is delivered in English)
have reliable internet access and basic competency in using online platforms (individuals will self-report)
Disqualifiers
have visual impairments or disabilities interfering with reading and ability to interact with online materials
have poorly managed anxiety or mood disorder (assessed using the degree of life interference evaluation at screening)
individuals who are in active treatment for their cancer (including radiation, chemotherapy and any planned surgeries).
Trial design
Factorial
Treatments tested in this trial
eSense-Cancer CBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancer
BehavioraleSense-Cancer CBT is an online, cognitive behavioural therapy based intervention for sexual health concerns after gynecologic cancer. eSense-Cancer CBT contains 8 modules and is intended to be completed over 8-16 weeks. It contains theoretical content, case-based learning, and at-home exercises.
Navigator support for eSense-Cancer
BehavioralThe eSense digital health tool has been previously tested alongside the support of treatment navigators - trained undergraduate students, not licensed therapists, who provide encouragement and answer any questions users may have as they work through eSense.
Behavioral: eSense-Cancer MBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancer
BehavioraleSense-Cancer MBT is an online, mindfulness-based therapy based intervention for sexual health concerns after gynecologic cancer. eSense-Cancer MBT contains 8 modules and is intended to be completed over 8-16 weeks. It contains theoretical content, case-based learning, and at-home exercises.
Treatment groups
Trial outcomes
Primary outcomes
A change in sexual distress (FSDS-R)
Sexual distress will be measured using the Female Sexual Distress Scale-Revised (FSDS-R). This scale is measured on a scale of 0-52 with higher values representing more distress.
A change in sexual function and satisfaction (PROMIS SexFs)
The PROMIS SexFS scale will be used to measure sexual function and satisfaction. The scale consists of 14 questions with higher scores indicating greater levels of sexual function and satisfaction. Scores are differentially calculated for those who are sexually active versus not sexually active.
Secondary outcomes
Treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
Adapted Erectile Dysfunction Inventory of Treatment Satisfaction. Scores range from 0-40, with higher scores reflecting higher treatment satisfaction.
Global Impressions of eSense-Cancer
Global impressions of the intervention will be assessed by adapting questions developed by previous work on eSense. All questions are free-response.
Usability of each module
11-items regarding impressions and the ease of use of each module in eSense-Cancer. These are in-house developed items. 5 items are qualitative, 6 items are quantitative.
Treatment satisfaction of each module
Face-valid single-item measures, asking participants to rate helpfulness of content covered each week, and ease of reading the content (0-10 scale). Research suggests a cut-off of 6.5/10 on these measures to indicate acceptable utility and clarity of content. Asked after completing each module.
Other outcomes
Treatment compliance: between-module activity completion assessed by Homework Rating Scale-II (moderator)
Participants complete the Homework Rating Scale-II (HRS-II) after each module. Scores can range from 0-48, with higher scores reflecting high levels of between-module activity completion.
Treatment compliance: Participant engagement with website as assessed by user analytics data capturing (moderator)
eSense-Cancer website engagement assessed by user analytics data (e.g., total duration of time on website). This will provide a measure of participant engagement.
Treatment compliance: Number of weeks in program (moderator)
Recording number of weeks participant took to complete the program.
Treatment compliance: Number of program modules completed (moderator)
Recording number of program modules participants complete.
Sponsors and contacts
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University of British Columbia
Lead sponsor
Xavier University of Louisiana.
Collaborator