Clinical trial NCT06619769: eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Official title: eSense-Cancer: Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic Cancers
Keywords: behavioural intervention
mindfulness based therapy
cognitive behavioural therapy
digital health
eHealth
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Xavier University of Louisiana.
First posted: 2024-10-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomized to receive either the cognitive-behavioural- or mindfulness-based arm of a digital therapeutic known as eSense-Cancer. Participants will also be randomly assigned to a condition that does or does not include support from a treatment navigator - a non-expert study team member to provide support throughout the treatment. Therefore there will be four groups to be compared:

* Cognitive-behavioural therapy + navigator support
* Cognitive-behavioural therapy + no navigator support
* Mindfulness-based therapy + navigator support
* Mindfulness-based therapy + no navigator support
Primary purpose: TREATMENT

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.

Detailed description: Once participants have consented to participate in the study, they will complete baseline questionnaires, then undergo a 4-week waiting period. After this 4 week waiting period, they will complete a second baseline questionnaire, and then be randomized to one of four arms:

* CBT with navigator support (n=15)
* CBT with no navigator support (n=15)
* MBT with navigator support (n=15)
* MBT with no navigator support (n=15)

Participants will receive an online link to complete the questionnaires consisting of demographics, primary outcomes (sexual distress; FSDS-R, and sexual function; PROMIS SexFS measure adapted for cancer survivors). For those in the navigator support arms, before beginning the eSense-Cancer modules, participants will have an initial 15-30 minute conversation via the UBC-hosted version of Zoom with their assigned navigator, who will explain their role.

Following this meeting, participants will gain access to the CBT or MBT arm of eSense-Cancer and receive an individualized link to access eSense-Cancer. They will work through one module weekly/biweekly (on their own time) and complete the related exercise during that week. This process should take 8-16 weeks. After each module, they will complete a questionnaire to assess usability of the module just completed.

For those in the navigator arms, when participants complete a module, they will fill out their calendar preferences to find a day and time to meet with their navigator over the next week. The navigator will receive an automatic email when their assigned participant has finished a module. If a week has passed and participants have not scheduled a time to meet with their navigator, the navigator will email the participant to schedule their meeting. These meetings will entail 2-3 minutes of general introduction, 10-15 minutes to check in on any eSense-Cancer-related concerns or questions that arose over the week, and 2-3 minutes to close and schedule their next session, for a total of 15-25 minutes.

Navigators will be current or graduated psychology undergraduate students with a GPA of 3.5, coursework or experience with research methods/clinical psychology/human sexuality. Navigators must be available to complete training and commit a minimum of a year to the project. As a licensed clinical psychologist, Dr. Brotto will interview potential navigators to assess their interpersonal skills, ability to listen empathetically, and comfort in discussing sexual issues. Navigators will receive training from co-investigator, Dr. Kyle Stephenson and other study team members to minimize inter-navigator variation. Navigators will have access to both treatment arms to familiarize themselves with eSense-Cancer content. They can choose whether they want to navigate participants in the CBT or MBT arms based on their interests. They will also be given a reading list relevant to treating women's sexual concerns.

After participants complete the final eSense-Cancer module, they will fill out a post-treatment set of questionnaires online. Using the evidence-based framework for feasibility testing, the investigators plan to measure the feasibility dimensions of:

* acceptability: how participants reacted to eSense- Cancer
* implementation: whether the program can be delivered online
* practicality: the ability of a small team to deliver the intervention without providing individualized guidance to participants)
* adaptation: whether the various skills and mindfulness exercises could be delivered online and if participants reported engaging with them)
* limited efficacy testing.

Specific measures include (a) global impressions of eSense-Cancer, (b) preliminary clinical outcomes and (c) navigator-related measures (only administered in the navigator arms):

1. . Global impressions of eSense-Cancer: After completing module 8, participants in both arms will be sent a link and asked qualitative questions on their impressions of the intervention
2. Clinical outcomes:

   1. Sexual distress (FSDS-R)
   2. Sexual function (PROMIS SexFS)
3. Navigator-related measures:

   1. Empathy subscale of Barrett-Lennard Relationship Inventory, a valid measure of perceived provider empathy that predicts outcomes in CBT
   2. Perceived navigator effectiveness with the Working Alliance Inventory, Short Form
   3. Amount of time spent with the participant; each navigator will track how long they spend and engage with each of their assigned participants throughout the eight modules.

The investigators will also use a validated measure of treatment acceptance (Treatment Evaluation Inventory), which has been described as the goodness of fit between the intervention and the system from which it is disseminated), including:

1. The number screened who are appropriate based on study inclusion/exclusion criteria, and from that figure, the number that enrolled in the study.
2. The percentage of participants that completed each intervention module and the entire protocol.
3. The percentage of participants lost to follow-up.

Participants will only receive access to one arm of eSense-Cancer, not both given that our goal is to measure and compare the feasibility and effect size of both arms separately.

Participants' treatment compliance will be measured:

* by recording the number of weeks and treatment sections completed
* through eSense website engagement and performance by a user engagement tracking platform (e.g. page views, #visits/sessions, page views/visits, visit duration, unique/returning users
* by a homework completion measure on a Likert scale ranging from \[did not attempt\] to \[completed all assignments\] weekly, which navigators will ask participants to complete
* by having participants complete the Homework Rating Scale (HRS) after each module to provide a comprehensive measure of experience with the homework
* by measuring navigator adherence to study guidelines by recording a random 20% of webcam sessions (with participant knowledge and consent) and coding them for compliance using an adherence scale that the investigators have utilized in the past.

The number of individuals who contact the study coordinator and express interest in the study, regardless of their eligibility, will also be recorded.

During the study, women must agree not to change medications known to have sexual side effects unless directed by their treating physician. (Study investigators will collect data on medication use at each assessment point.) Participants will also be encouraged to limit or eliminate internet research on sexual dysfunction during the trial. The post-treatment questionnaire will assess participant compliance with this request. Past research suggests that this request is feasible.

Eligibility criteria: 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 outcomes:
measure: A change in sexual distress (FSDS-R)
timeFrame: 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
measure: A change in sexual function and satisfaction (PROMIS SexFs)
timeFrame: 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:
measure: Treatment satisfaction as assessed by the adapted Erectile Dysfunction Inventory of Treatment Satisfaction
timeFrame: Assessed at post-treatment (T3): 8-16 weeks after treatment start
measure: Global Impressions of eSense-Cancer
timeFrame: Assessed at post-treatment (T3): 8-16 weeks after treatment start
measure: Usability of each module
timeFrame: Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
measure: Treatment satisfaction of each module
timeFrame: Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
Other outcomes:
measure: Treatment compliance: between-module activity completion assessed by Homework Rating Scale-II (moderator)
timeFrame: Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks.
measure: Treatment compliance: Participant engagement with website as assessed by user analytics data capturing (moderator)
timeFrame: Collected throughout engagement with the intervention. Collection will stop at post-treatment (8-16 weeks after treatment start)
measure: Treatment compliance: Number of weeks in program (moderator)
timeFrame: Assessed at post-treatment (T3) (8-16 weeks after treatment start).
measure: Treatment compliance: Number of program modules completed (moderator)
timeFrame: Assessed at post-treatment (T3) (8-16 weeks after treatment start)
measure: Perceived navigator empathy (moderator)
timeFrame: Assessed at post-treatment (T3) for those in a navigator support arm (8-16 weeks after treatment start)
measure: Perceived navigator alliance (moderator)
timeFrame: Assessed at post-treatment (T3) for those in a navigator arm (8-16 weeks after treatment start)
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Lori A Brotto, PhD, RPsych
role: PRINCIPAL_INVESTIGATOR
affiliation: Xavier University of Louisiana.
name: Kyle Stephenson, PhD, RPsych
role: PRINCIPAL_INVESTIGATOR
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citation: Brotto 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.