Ignite Creation Date:
2024-05-06 @ 10:50 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03365518
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2017-12-01
Brief Title:
Innovations in the Treatment of Sexual Health Post Prostate Cancer Treatment Comparing Mindfulness vs CBT
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Innovations in the Treatment of Sexual Dysfunction and Couple Intimacy After Prostate Cancer A Randomized Trial of Mindfulness Versus Cognitive Behavioural Therapy
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTROSPPECT
Brief Summary:
Up to 90 of men experience sexual difficulties after receiving treatment for prostate cancer PC which can negatively affect their intimate relationships and overall quality of life In this randomized clinical trial the investigators will assess and compare two evidence-based treatments mindfulness-based therapy and cognitive behavioral therapy CBT for couples with sexual complaints following PC treatment to controls who will receive no intervention
Detailed Description:
This randomized clinical trial is designed to assess and compare efficacy of two treatment manuals for couples with sexual difficulties secondary to PC treatment mindfulness-based therapy and CBT A third arm where couples receive no intervention will act as a control group Those randomized to the control group will have the opportunity to be randomized to one of the treatment groups following their third and final questionnaire if they wish
Men and their partners will be invited to participate through the Vancouver Prostate Centres Prostate Cancer Supportive Care Program PCSC at Vancouver General Hospital
Eligible couples will be randomized to either 4 consecutive weeks of mindfulness-based therapy CBT or no intervention 4-6 couples in each treatment group at a time All participants will complete an online questionnaire package to assess primary secondary and tertiary outcomes at the time of study enrollment or baseline Time 1 All participants will be invited to complete a Time 2 questionnaire once approximately 6 weeks after they complete the Time 1 questionnaire for couples randomized to the treatment arms this will be immediately post-treatment Finally all participants will be invited to complete the Time 3 follow up questionnaire 6 months after they complete the Time 2 post-treatment questionnaire
Endpoints will assess effects on intimacy and overall Quality of Life Additional endpoints of other factors affecting improvement ie moderators like personality and treatment adherence will be assessed The investigators predict improvements in both mindfulness-based and cognitive behavioural therapy treatments moderators will provide insights into which participants benefit most from each treatment arm
Moreover in order to improve understanding of the lived experience of patients who take part in the treatment groups or control arm this study will invite all participants to take part in an exit interview after their Time 2 post-treatment questionnaire is completed A research team member who was not a treatment facilitator will conduct the exit interviews This information will then be transcribed and used for qualitative data analyses
Men and their partners will be invited to participate through the Vancouver Prostate Centres Prostate Cancer Supportive Care Program PCSC at Vancouver General Hospital
Eligible couples will be randomized to either 4 consecutive weeks of mindfulness-based therapy CBT or no intervention 4-6 couples in each treatment group at a time All participants will complete an online questionnaire package to assess primary secondary and tertiary outcomes at the time of study enrollment or baseline Time 1 All participants will be invited to complete a Time 2 questionnaire once approximately 6 weeks after they complete the Time 1 questionnaire for couples randomized to the treatment arms this will be immediately post-treatment Finally all participants will be invited to complete the Time 3 follow up questionnaire 6 months after they complete the Time 2 post-treatment questionnaire
Endpoints will assess effects on intimacy and overall Quality of Life Additional endpoints of other factors affecting improvement ie moderators like personality and treatment adherence will be assessed The investigators predict improvements in both mindfulness-based and cognitive behavioural therapy treatments moderators will provide insights into which participants benefit most from each treatment arm
Moreover in order to improve understanding of the lived experience of patients who take part in the treatment groups or control arm this study will invite all participants to take part in an exit interview after their Time 2 post-treatment questionnaire is completed A research team member who was not a treatment facilitator will conduct the exit interviews This information will then be transcribed and used for qualitative data analyses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| D2017-1893 | OTHER_GRANT | Movember Discovery GrantProstate Cancer Canada | None |