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):
. 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
Clinical outcomes:
Sexual distress (FSDS-R)
Sexual function (PROMIS SexFS)
Navigator-related measures:
Empathy subscale of Barrett-Lennard Relationship Inventory, a valid measure of
perceived provider empathy that predicts outcomes in CBT
Perceived navigator effectiveness with the Working Alliance Inventory, Short
Form
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:
The number screened who are appropriate based on study inclusion/exclusion criteria,
and from that figure, the number that enrolled in the study.
The percentage of participants that completed each intervention module and the
entire protocol.
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.