Ignite Creation Date:
2024-05-06 @ 6:27 PM
Last Modification Date:
2024-10-26 @ 2:48 PM
Study NCT ID:
NCT05676255
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2022-12-22
Brief Title:
The Breast Cancer Survivors and Partners Online Research Together SUPORT Project
Sponsor:
University of Arizona
Organization:
University of Arizona
Study Overview
Official Title:
The SUPORT Project Leveraging Social Connection by Including Informal Caregivers in an Internet Video Conference-based Compassion Meditation Intervention to Reduce Psychological Distress in Breast Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Many breast cancer survivors estimated 70 in some studies experience clinically significant depression andor anxiety in the months and years after finishing cancer treatments This research will build on the rigor of prior research to reduce breast cancer survivor depression and anxiety with a compassion meditation intervention called CBCT Cognitively-Based Compassion Training for online synchronous delivery that is also inclusive of informal caregivers ie adult family members who live with and typically provide half the care for survivors aka supportive partners
Detailed Description:
The goal of this project is to determine if CBCT Cognitively-Based Compassion Training can reduce distress for survivors compared to an attention control Health Education HE when delivered by Zoom to both survivors and caregivers supportive partners as a dyad ie CBCT for dyads CBCT-D We will also test whether instructing survivors and caregivers supportive partners together in CBCT CBCT-D reduces distress more than when survivors receive CBCT instruction by themselves without caregivers supportive partners ie CBCT for survivors CBCT-S The following specific aims address these questions
Aim 1 Determine if survivors and caregivers supportive partners exhibit less depression and anxiety primary outcomes when survivors receive online CBCT along with their informal caregiver supportive partner CBCT-D compared to when survivors receive online CBCT alone CBCT-S or when survivors and informal caregivers supportive partners receive online HE We will recruit dyads N226 consisting of survivors between 3 months and 5 years post treatments with curative intent ie chemotherapy radiation surgery and their caregivers supportive partners H1 Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress ie depression anxiety primary outcomes in survivors at months 2 3 and 8 versus those randomized to CBCT-S or HE
Aim 2 Test the extent to which reductions in survivors depression and anxiety from online CBCT-D are mediated by social connection dyadic function and caregiver supportive partner distress H2a Survivors social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivors distress at months 2 3 and 8 H2b Caregivers social connection dyadic function and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivors distress
Aim 3 Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2 3 and 8 and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivors distress at month 2 3 and 8
Aim 1 Determine if survivors and caregivers supportive partners exhibit less depression and anxiety primary outcomes when survivors receive online CBCT along with their informal caregiver supportive partner CBCT-D compared to when survivors receive online CBCT alone CBCT-S or when survivors and informal caregivers supportive partners receive online HE We will recruit dyads N226 consisting of survivors between 3 months and 5 years post treatments with curative intent ie chemotherapy radiation surgery and their caregivers supportive partners H1 Survivors and caregivers randomized to CBCT-D will exhibit greater improvements in distress ie depression anxiety primary outcomes in survivors at months 2 3 and 8 versus those randomized to CBCT-S or HE
Aim 2 Test the extent to which reductions in survivors depression and anxiety from online CBCT-D are mediated by social connection dyadic function and caregiver supportive partner distress H2a Survivors social connection and dyadic function will mediate the effects of online CBCT-D versus HE on survivors distress at months 2 3 and 8 H2b Caregivers social connection dyadic function and distress will mediate the effects of CBCT-D versus CBCT-S or HE on survivors distress
Aim 3 Explore the effects of online CBCT-D versus CBCT-S and HE on survivor diurnal cortisol rhythm at months 2 3 and 8 and the extent to which cortisol rhythm is a marker versus mediator of improvements in survivors distress at month 2 3 and 8
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 |
|---|---|---|---|
| R01CA264047 | NIH | None | httpsreporternihgovquickSearchR01CA264047 |