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.
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 Acts 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 meaning and purpose, life satisfaction and global mental health 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, meaning and purpose, depression, anxiety, and global mental health 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, meaning and purpose, depression, anxiety, and global mental health. * 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, meaning and purpose, depression, anxiety and global mental health.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
352
Participants will receive weekly material for a total of 5 weeks consisting of 1-2 days of didactic content and several days of brief, real-life skills practice and reporting taking approximately 10-15 minutes to complete. Adolescents and young adults cannot skip ahead, but they can return to old lessons or exercises if they choose. Most exercises are done in a "diary" format in which past responses are displayed next to their new ones, so that every time they visit that exercise they see their growing list of past positive experiences. Participants will be permitted up to 8 weeks to complete this self-guided intervention.
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
T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
Participants completed 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. We used a mixed model to estimate the mean within-group value of the outcome (positive affect T-score) at each time point following the intervention. Average score (50): Represents the national average for the general population. 50 indicates the population mean with a standard deviation of 10 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.
Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
T0 and T6 Anxiety T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT) Questionnaire
Participants completed 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. We used a mixed model to estimate the mean within-group value of the outcome (positive affect T-score) at each time point following the intervention. Average score (50): Represents the national average for the general population. 50 indicates the population mean with a standard deviation of 10 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.
Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
T0 and T6 Depression T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire
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Participants completed 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. We used a mixed model to estimate the mean within-group value of the outcome (positive affect T-score) at each time point following the intervention. Average score (50): Represents the national average for the general population. 50 indicates the population mean with a standard deviation of 10 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.
Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
T0 and T6 Life Satisfaction T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire
Participants completed 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. We used a mixed model to estimate the mean within-group value of the outcome (positive affect T-score) at each time point following the intervention. Average score (50): Represents the national average for the general population. 50 indicates the population mean with a standard deviation of 10 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.
Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)