eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer

NCT06619769 · tracked via the Priya Life Science Canada tracker

Sponsor

University of British Columbia

Phase

Not applicable

Started

2024-10-01

Last updated

2025-09-25

Condition(s) studied

Gynecologic Cancers

Investigational drug(s) / intervention(s)

eSense-Cancer CBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancerNavigator support for eSense-CancerBehavioral: eSense-Cancer MBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancer

eSense-Cancer CBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancer: eSense-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: The 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: eSense-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.

Study summary

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

Sex

FEMALE

Min age

19 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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) * are available for 8 - 16 weeks and able to complete eSense modules and associated questionnaires * any gender Exclusion Criteria: * 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).

Primary outcome measure(s)

A change in sexual distress (FSDS-R) — Assessed at enrolment (T1), treatment start (T2) and treatment end (T3). Time between T1 and T2: 4 weeks. Time between T2 and T3: 8-16 weeks
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) — Assessed at enrolment (T1), treatment start (T2) and treatment end (T3). Time between T1 and T2: 4 weeks. Time between T2 and T3: 8-16 weeks
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.

Trial sites (1)

Facility	City	Region	Status
University of British Columbia	Vancouver	British Columbia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619769 on ClinicalTrials.gov ↗ ← All trials in Canada