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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19+
SponsorUniversity of British Columbia

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 volunteers

Qualifiers

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

Design model

Factorial

Treatments tested in this trial

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

    Behavioral

    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

    Behavioral

    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

    Behavioral

    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.

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: CBT - NavigatorActive comparator 2 interventions
Group B: CBT - No navigatorActive comparator 1 intervention
Group C: MBT - NavigatorActive comparator 2 interventions
Group D: MBT - No navigatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

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
2

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.

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

Secondary outcomes

1

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.

Time frame
Assessed at post-treatment (T3): 8-16 weeks after treatment start
2

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.

Time frame
Assessed at post-treatment (T3): 8-16 weeks after treatment start
3

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.

Time frame
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
4

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.

Time frame
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.

Other outcomes

1

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.

Time frame
Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
2

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.

Time frame
Collected throughout engagement with the intervention. Collection will stop at post-treatment (8-16 weeks after treatment start)
3

Treatment compliance: Number of weeks in program (moderator)

Recording number of weeks participant took to complete the program.

Time frame
Assessed at post-treatment (T3) (8-16 weeks after treatment start).
4

Treatment compliance: Number of program modules completed (moderator)

Recording number of program modules participants complete.

Time frame
Assessed at post-treatment (T3) (8-16 weeks after treatment start)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

Xavier University of Louisiana.

Collaborator