MOST EMPOWER: Optimizing An Emotion Regulation Intervention

Not Applicable

Completed

• Conditions: Cancer

• Registration Number: NCT04317417
• Lead Sponsor: Wake Forest University Health Sciences

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, 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.

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-20
• Study First Posted: 2020-03-23
• Study Start: 2022-01-06
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

• Able to read and understand English
• Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
• 15 to 39 years of age at diagnosis of first cancer and currently between the ages of 15 to 39
• Within 0-5 year's post-active treatment for initial diagnosis or recurrence (Note: Maintenance therapy for hematologic or hormonal therapy for breast cancers are not considered "active treatments" for purposes of this study).
• Internet access through a home computer, tablet or smartphone.

Exclusion Criteria

• Ever been hospitalized for a psychiatric illness
• Currently receiving palliative or hospice care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire	Baseline up to 4 months after intervention	Participants will complete a self-reported questionnaire on psychological well being for feelings that reflect a level of pleasurable engagement with the environment, such as happiness, joy, excitement, enthusiasm, and contentment over the past seven days. A mixed model adjusted for baseline to model the value of the outcome (positive affect) at each time point following the intervention. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. There is no fixed minimum or maximum score.; Average score (50): Represents the national average for the general population. Higher scores (\>50): Indicate higher positive affect than the general population. For example, a T-score of 60 is one standard deviation better than the national average.; Lower scores (\<50): Indicate lower positive affect than the general population. A T-score of 40 is one standard deviation worse than the national average.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire	Baseline up to 4 months after intervention	Participants will complete a self-reported questionnaire to capture the negative aspects of anxiety in the past seven days. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. A higher T-score indicates more of the concept being measured, so higher scores correlate with greater anxiety.; Below 50: Lower than the average anxiety level of the general population. 50: The average anxiety level for the general population.; Above 50: Higher than the average anxiety level of the general population. The severity can be categorized as follows: Less than or equal to 55: Within normal limits. 55-60: Mild anxiety. 60-70: Moderate anxiety. A score of 60 is one standard deviation above the mean.; \> 70: Severe anxiety.
Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire	Baseline up to 4 months after intervention	Participants will complete a self-reported questionnaire to capture the negative aspects of depression over the past seven days. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate a greater severity of depressive symptoms.; T-score of 50: This score indicates no to slight symptoms. T-score of 60: This score indicates at least moderate depression symptoms. T-scores below 50: These scores indicate fewer depressive symptoms than the average person.; T-scores above 50: These scores indicate more depressive symptoms than the average person.
Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire	Baseline up to 4 months after intervention	Participants will complete a self-reported questionnaire to capture the positive (life satisfaction) aspects of emotional health. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. There is no set minimum or maximum score, scores usually fall within the 20 to 80 range.; A T-score of 50 indicates a level of life satisfaction that is average for the U.S. general population.; Higher scores represent higher levels of life satisfaction. Lower scores represent lower levels of life satisfaction.

Trial Locations

Locations (3)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Wake Forest Baptist Comprehensive Cancer Center; 🇺🇸 Winston-Salem, North Carolina, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States