Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03344757
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2017-09-27
Brief Title:
Health Gatherings - For Your Health After Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Culturally Adapted Cognitive Behavioral Stress and Self-Management C-CBSM Intervention for Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The purpose of this study is to look at the effects of a 10-week stress management in-person group program The program will study emotions stress and stress management techniques such as relaxation and coping techniques on quality of life distress depression and physical health in Spanish- speaking HispanicLatino men diagnosed with Prostate Cancer PC
Detailed Description:
This 5-year study evaluates the effects of a 10-week group-based linguistically translated and culturally adapted cognitive-behavioral stress and self-management C-CBSM intervention on symptom burden and health related quality of life HRQoL in Hispanic men treated for localized prostate cancer PC About 80 PC cases are diagnosed as early disease and have a 5- and 10-year survival rate of almost 100 and 99 respectively1 Most patients receive active treatment 70 leading to prolonged treatment-related side effects and dysfunction persisting well beyond primary treatment Survival is offset by chronic side effects such as sexual and urinary dysfunction pain and fatigue that can lead to poor psychosocial functioning impaired intimacy and social functioning and masculinity concerns Hispanic PC survivors report lower physical and social functioning poorer emotional well-being and greater sexual and urinary dysfunction even after accounting for SES and disease severity These sequelae can lead to elevated glucocorticoid release and inflammatory cytokines that have a direct effect on these symptoms and can interfere with physiological pathways necessary for recovery of sexual and urinary functioning We have shown that CBSM reduces symptom burden and improves HRQoL in bilingual Hispanic PC survivors In a pilot we showed that a linguistic translation of CBSM with attention to sociocultural processes improved symptom burden and HRQoL in Spanish monolingual PC survivors We have also shown that CBSM is associated with reduced glucocorticoid resistance and inflammatory gene expression pathways in circulating leukocytes among breast cancer survivors We propose to a deliver a culturally adapted C-CBSM intervention in Spanish that places greater emphasis on salient sociocultural determinants of symptom burden and HRQoL in Hispanics eg fatalistic attitudes family interdependence perceived discrimination machismo b incorporate a neuroimmune model of symptom regulation and management and c test the efficacy of C-CBSM relative to standard non-culturally adapted CBSM in two diverse Hispanic communities Chicago Miami We will test our aims in 200 Hispanic men post-treatment for localized PC with elevated symptom burden in a 2 x 4 randomized design with condition C-CSBM vs CBSM as the between groups factors and time baseline post-intervention 6- and 12-months post intervention as the within groups factor
Our Primary Aim is to determine whether randomization to C-CBSM relative to standard CBSM is associated with reduced symptom burden and improved HRQoL Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets eg stress management psychological distress interpersonal disruption and physiologic adaptation ie glucocorticoid receptor sensitivity inflammatory gene expression We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSMs effects on our primary outcomes We also explore several moderators eg SES acculturation treatment Hispanic origin of C-CBSMs effect on primary outcomes and the effects of C-CBSM on cardiometabolic health eg lipids fasting glucose via reduced inflammation
Primary Aim 1 Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom burden and improvements in HRQoL relative to participation in CBSM
Secondary Aims
Aim 2 Determine whether participation in C-CBSM is associated with significantly greater improvements in intervention targets ie improved stress management and reduced psychological distress and interpersonal disruption relative to participation in the CBSM condition
Aim 3 Determine whether participation in C-CBSM is associated with significantly greater activation of leukocyte glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM
Aim 4 Determine whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles
Our Primary Aim is to determine whether randomization to C-CBSM relative to standard CBSM is associated with reduced symptom burden and improved HRQoL Our Secondary Aims evaluate whether C-CBSM leads to greater improvements in the intervention targets eg stress management psychological distress interpersonal disruption and physiologic adaptation ie glucocorticoid receptor sensitivity inflammatory gene expression We will also evaluate psychosocial and physiological mechanisms as mediators of C-CBSMs effects on our primary outcomes We also explore several moderators eg SES acculturation treatment Hispanic origin of C-CBSMs effect on primary outcomes and the effects of C-CBSM on cardiometabolic health eg lipids fasting glucose via reduced inflammation
Primary Aim 1 Determine whether participation in C-CBSM is associated with significantly greater reductions in symptom burden and improvements in HRQoL relative to participation in CBSM
Secondary Aims
Aim 2 Determine whether participation in C-CBSM is associated with significantly greater improvements in intervention targets ie improved stress management and reduced psychological distress and interpersonal disruption relative to participation in the CBSM condition
Aim 3 Determine whether participation in C-CBSM is associated with significantly greater activation of leukocyte glucocorticoid receptor and less inflammatory gene expression profiles relative to CBSM
Aim 4 Determine whether C-CBSM related improvements in symptom burden and HRQoL are mediated by improvements in intervention targets and gene expression profiles
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 |
|---|---|---|---|
| STU00203197 | OTHER | None | None |
| 1R01CA206456-01A1 | NIH | Northwestern ID | httpsreporternihgovquickSearch1R01CA206456-01A1 |