Ignite Creation Date:
2024-05-06 @ 2:25 PM
Last Modification Date:
2024-10-26 @ 1:31 PM
Study NCT ID:
NCT04317417
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-03-19
Brief Title:
MOST EMPOWER Optimizing An Emotion Regulation Intervention
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Using MOST to EMPOWER Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
MOST EMPOWER
Brief Summary:
This purpose of this study is to test a digital health intervention that may promote well-being among young adult cancer survivors Investigators hope to learn more about wellness and health-related quality of life among young adult cancer survivors by promoting well-being and teaching skills for healthy coping and mood management
Detailed Description:
The EMPOWER Intervention is composed of five components
1 Noting daily positive event capitalizing on and savoring positive events and gratitude
2 Mindfulness
3 Positive Reappraisal
4 Focusing on personal strengths setting and working toward attainable goals
5 Small of Kindness
For subjects who do not receive EMPOWER components or only receive some of the EMPOWER components they will be given inert content The inert content will cover Cognitive changes during Cancer Diet Weight Management Financial Literacy and Sun Protection The trial is a composed of a full factorial design with 32 2X2X2X2X2 experimental conditions Adolescents and Young Adults will receive 0 1234 or 5 Empower components
Primary Objective
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to positive affect among post-treatment adolescent and young adult cancer survivors
Secondary Objective
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to depression and anxiety among post-treatment adolescent and young adult cancer survivors
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to life satisfaction and general self-efficacy among post-treatment adolescent and young adult cancer survivors
Exploratory Objectives
Summarize adherence and retention by participants over the course of the EMPOWER intervention
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to physical functioning fatigue satisfaction with social roles and responsibilities
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to health behaviors diet exercise sedentary behavior alcohol consumption cigarette smoking
Examine the trajectory of change in positive affect life satisfaction general self-efficacy depression and anxiety among post-treatment adolescent and young adult cancer survivors post intervention by intervention component
Examine coping self-efficacy as a mediator of the relationship between EMPOWER intervention components and positive affect life satisfaction depression and anxiety
Examine potential moderators age gender social support general self-efficacy stressors and positive events of the relationship between EMPOWER intervention components and positive affect life satisfaction depression and anxiety
1 Noting daily positive event capitalizing on and savoring positive events and gratitude
2 Mindfulness
3 Positive Reappraisal
4 Focusing on personal strengths setting and working toward attainable goals
5 Small of Kindness
For subjects who do not receive EMPOWER components or only receive some of the EMPOWER components they will be given inert content The inert content will cover Cognitive changes during Cancer Diet Weight Management Financial Literacy and Sun Protection The trial is a composed of a full factorial design with 32 2X2X2X2X2 experimental conditions Adolescents and Young Adults will receive 0 1234 or 5 Empower components
Primary Objective
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to positive affect among post-treatment adolescent and young adult cancer survivors
Secondary Objective
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to depression and anxiety among post-treatment adolescent and young adult cancer survivors
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to life satisfaction and general self-efficacy among post-treatment adolescent and young adult cancer survivors
Exploratory Objectives
Summarize adherence and retention by participants over the course of the EMPOWER intervention
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to physical functioning fatigue satisfaction with social roles and responsibilities
Identify which of five components in the EMPOWER web based curriculum contribute meaningfully to health behaviors diet exercise sedentary behavior alcohol consumption cigarette smoking
Examine the trajectory of change in positive affect life satisfaction general self-efficacy depression and anxiety among post-treatment adolescent and young adult cancer survivors post intervention by intervention component
Examine coping self-efficacy as a mediator of the relationship between EMPOWER intervention components and positive affect life satisfaction depression and anxiety
Examine potential moderators age gender social support general self-efficacy stressors and positive events of the relationship between EMPOWER intervention components and positive affect life satisfaction depression and anxiety
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 |
|---|---|---|---|
| R01CA242849-01 | NIH | Wake Forest Baptist Comprehensive Cancer Center | httpsreporternihgovquickSearchR01CA242849-01 |
| WFBCCC 04220 | OTHER | None | None |