eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
eSense-Cancer
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
ExpectedSeptember 25, 2025
February 1, 2025
1.5 years
September 27, 2024
September 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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
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.
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
Secondary Outcomes (4)
Treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
Assessed at post-treatment (T3): 8-16 weeks after treatment start
Global Impressions of eSense-Cancer
Assessed at post-treatment (T3): 8-16 weeks after treatment start
Usability of each module
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
Treatment satisfaction of each module
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
Other Outcomes (6)
Treatment compliance: between-module activity completion assessed by Homework Rating Scale-II (moderator)
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
Treatment compliance: Participant engagement with website as assessed by user analytics data capturing (moderator)
Collected throughout engagement with the intervention. Collection will stop at post-treatment (8-16 weeks after treatment start)
Treatment compliance: Number of weeks in program (moderator)
Assessed at post-treatment (T3) (8-16 weeks after treatment start).
- +3 more other outcomes
Study Arms (4)
CBT - Navigator
ACTIVE COMPARATORParticipants will complete the CBT arm of eSense with support from a treatment "navigator"
CBT - No navigator
ACTIVE COMPARATORParticipants will complete the CBT arm of eSense without support from a treatment "navigator"
MBT - Navigator
ACTIVE COMPARATORParticipants will complete the MBT arm of eSense with support from a treatment "navigator"
MBT - No navigator
ACTIVE COMPARATORParticipants will complete the MBT arm of eSense without support from a treatment "navigator"
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- Xavier University of Louisiana.collaborator
Study Sites (1)
University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
Related Publications (5)
Barrett-Lennard GT. The Relationship Inventory: A Complete Resource and Guide.
BACKGROUNDBaker TB, Gustafson DH, Shaw B, Hawkins R, Pingree S, Roberts L, Strecher V. Relevance of CONSORT reporting criteria for research on eHealth interventions. Patient Educ Couns. 2010 Dec;81 Suppl:S77-86. doi: 10.1016/j.pec.2010.07.040. Epub 2010 Sep 16.
PMID: 20843621BACKGROUNDDerogatis L, Clayton A, Lewis-D'Agostino D, Wunderlich G, Fu Y. Validation of the female sexual distress scale-revised for assessing distress in women with hypoactive sexual desire disorder. J Sex Med. 2008 Feb;5(2):357-64. doi: 10.1111/j.1743-6109.2007.00672.x. Epub 2007 Nov 27.
PMID: 18042215BACKGROUNDKazdin AE. Acceptability of alternative treatments for deviant child behavior. J Appl Behav Anal. 1980 Summer;13(2):259-73. doi: 10.1901/jaba.1980.13-259.
PMID: 7380752BACKGROUNDBrotto LA, Stephenson KR, Zippan N. Feasibility of an Online Mindfulness-Based Intervention for Women with Sexual Interest/Arousal Disorder. Mindfulness (N Y). 2022;13(3):647-659. doi: 10.1007/s12671-021-01820-4. Epub 2022 Jan 4.
PMID: 35035598BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Lori A Brotto, PhD, RPsych
University of British Columbia
- PRINCIPAL INVESTIGATOR
Kyle Stephenson, PhD, RPsych
Xavier University of Louisiana.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 27, 2024
First Posted
October 1, 2024
Study Start
October 1, 2024
Primary Completion
March 30, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
September 25, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- The data will be made available within 3 months after publication.
- Access Criteria
- The data will be freely available on the OSF website so no need for requests.
We will be providing all IPD that underlie results in a publication. We will provide Analytic Code only in addition to the data and data dictionaries. Other information will be presented in the publications or available upon request from the main author or PI.