Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04806724
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2021-03-16
Brief Title:
Opening the Conversation Study
Sponsor:
Oregon State University
Organization:
Oregon State University
Study Overview
Official Title:
Opening the Conversation for Couples With Reproductive Health Concerns
Status:
RECRUITING
Status Verified Date:
2023-04
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:
None
Brief Summary:
Young adult survivors of breast and gynecologic cancer face a number of challenges including interrupted life plans As many as two-thirds of these young survivors experience negative effects of cancer and cancer treatment on their reproductive health including sexual function and ability to have children These are among the most distressing aspects of life after cancer for young survivors and their partners and when left unaddressed lead to poorer mental health and quality of life Yet surprisingly evidence-based programs are not available to help young couples manage this aspect of life after cancer In this study we will adapt and evaluate an intervention designed to help young couples cope with and communicate about cancer-related reproductive and sexual health concerns
Detailed Description:
The specific aims of the study are
Aim 1 Phase I Systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer BGC survivors and their partners jointly manage the reproductive and sexual health consequences of cancer
Aim 2 Phase II - Quantitative Evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial We will evaluate the efficacy of the newly adapted intervention Opening the Conversation OC on survivors and their partners reproductive and sexual distress as well as the relationship sexual and psychosocial health outcomes We will determine whether dyadic coping and communication mediate intervention effects on survivors and partners reproductive and sexual distress
Aim 3 Phase II - Qualitative Evaluate couples experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes
Aim 1 Phase I Systematically adapt an empirically supported couple-based skills training intervention to help young breast and gynecologic cancer BGC survivors and their partners jointly manage the reproductive and sexual health consequences of cancer
Aim 2 Phase II - Quantitative Evaluate the efficacy of the intervention and hypothesized mediators by conducting a randomized trial We will evaluate the efficacy of the newly adapted intervention Opening the Conversation OC on survivors and their partners reproductive and sexual distress as well as the relationship sexual and psychosocial health outcomes We will determine whether dyadic coping and communication mediate intervention effects on survivors and partners reproductive and sexual distress
Aim 3 Phase II - Qualitative Evaluate couples experiences within and across conditions to gain in-depth knowledge of intervention components that influence hypothesized mediators and outcomes
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