Recruiting

Sexual Health

Sponsor:

University of British Columbia

Code:

NCT06619769

Conditions

Gynecologic Cancers

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

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

Navigator support for eSense-Cancer

Behavioral: eSense-Cancer MBT: an online cognitive-behavioural therapy based intervention for sexual health concerns after gynecologic cancer

Study Details

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.

Conditions

Gynecologic Cancers

Study ID

NCT06619769

Start date

Oct 1, 2024

Status verified date

Feb, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CBT - Navigator

Participants will complete the CBT arm of eSense with support from a treatment "navigator"

active comparator: CBT - No navigator

Participants will complete the CBT arm of eSense without support from a treatment "navigator"

active comparator: MBT - Navigator

Participants will complete the MBT arm of eSense with support from a treatment "navigator"

active comparator: MBT - No navigator

Participants will complete the MBT arm of eSense without support from a treatment "navigator"

Interventions

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.

Primary outcome measure

  • A change in sexual distress (FSDS-R) [ Time Frame: 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) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Nisha Marshall, MSc

6048754111nisha.marshall@cw.bc.ca

Kira McNamee

6048754111kira.mcnamee@vch.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Contacts

Nisha Marshall, MSc

6048754111nisha.marshall@cw.bc.ca

Kira McNamee

6048754111kira.mcnamee@vch.ca

Principal Investigator:

Lori A Brotto, PhD, RPsych

More Information

Sponsor

University of British Columbia

Last update posted

Sep 25, 2025

Last verified

Feb, 2025

Keywords

  • behavioural intervention
  • mindfulness based therapy
  • cognitive behavioural therapy
  • digital health
  • eHealth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-09-25.