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| Name | Class |
|---|---|
| Xavier University of Louisiana. | OTHER |
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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.
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:
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:
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:
Navigator-related measures:
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT - Navigator | Active Comparator | Participants will complete the CBT arm of eSense with support from a treatment "navigator" |
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| CBT - No navigator | Active Comparator | Participants will complete the CBT arm of eSense without support from a treatment "navigator" |
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| MBT - Navigator | Active Comparator | Participants will complete the MBT arm of eSense with support from a treatment "navigator" |
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| MBT - No navigator | Active Comparator | Participants will complete the MBT arm of eSense without support from a treatment "navigator" |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at post-treatment (T3): 8-16 weeks after treatment start |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed after completion of each module. There are 8 modules total. Each module should be completed in 1-2 weeks. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nisha Marshall, MSc | Contact | 6048754111 | 68901 | nisha.marshall@cw.bc.ca |
| Kira McNamee | Contact | 6048754111 | 68901 | kira.mcnamee@vch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Lori A Brotto, PhD, RPsych | University of British Columbia | Principal Investigator |
| Kyle Stephenson, PhD, RPsych | Xavier University of Louisiana. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Barrett-Lennard GT. The Relationship Inventory: A Complete Resource and Guide. | ||
| 20843621 | Background | Baker 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. | |
| 18042215 |
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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.
The data will be made available within 3 months after publication.
The data will be freely available on the OSF website so no need for requests.
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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:
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| 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. |
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| 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. |
|
| 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. |
| Assessed at post-treatment (T3): 8-16 weeks after treatment start |
| 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. | 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 | 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. | 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) | 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. | 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) | Recording number of weeks participant took to complete the program. | Assessed at post-treatment (T3) (8-16 weeks after treatment start). |
| Treatment compliance: Number of program modules completed (moderator) | Recording number of program modules participants complete. | Assessed at post-treatment (T3) (8-16 weeks after treatment start) |
| Perceived navigator empathy (moderator) | Empathy subscale of the Barrett-Lennard Relationship Inventory. Scores range from -48 to 48, with higher scores reflecting that participants perceive higher levels of empathy in their navigator. | Assessed at post-treatment (T3) for those in a navigator support arm (8-16 weeks after treatment start) |
| Perceived navigator alliance (moderator) | Perceived navigator alliance with the Working Alliance Inventory, Short Form. Scores range from 12-84, with higher levels reflecting that participants perceive higher levels of working alliance with their navigator. | Assessed at post-treatment (T3) for those in a navigator arm (8-16 weeks after treatment start) |
| Background |
| Derogatis 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. |
| 7380752 | Background | Kazdin 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. |
| 35035598 | Background | 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. |