Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Factorial AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 39 years
Gender
Both males and females

Description

The EMPOWER Intervention is composed of five components: Noting daily positive event, capitalizing on and savoring positive events, and gratitude. Mindfulness Positive Reappraisal Focusing on personal strengths, setting and working toward attainable goals Small of Kindness For subjects who do not re...

The EMPOWER Intervention is composed of five components: Noting daily positive event, capitalizing on and savoring positive events, and gratitude. Mindfulness Positive Reappraisal Focusing on personal strengths, setting and working toward attainable goals 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, 1,2,3,4 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.

Tracking Information

NCT #
NCT04317417
Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: John M Salsman, Ph.D Wake Forest University Health Sciences