Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619769
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-27
Brief Title:
ESense-Cancer Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ESense-Cancer Adapting an Online Intervention for Sexual Health Concerns to Gynecologic Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eSense-Cancer
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 n15
CBT with no navigator support n15
MBT with navigator support n15
MBT with no navigator support n15
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 weeklybiweekly 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 35 coursework or experience with research methodsclinical psychologyhuman 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 womens 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 inclusionexclusion 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 eg page views visitssessions page viewsvisits visit duration uniquereturning 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
CBT with navigator support n15
CBT with no navigator support n15
MBT with navigator support n15
MBT with no navigator support n15
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 weeklybiweekly 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 35 coursework or experience with research methodsclinical psychologyhuman 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 womens 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 inclusionexclusion 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 eg page views visitssessions page viewsvisits visit duration uniquereturning 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None