CompletedNCT04317417MOST EMPOWERUpdated Jul 9, 2026Results posted

MOST EMPOWER: Optimizing An Emotion Regulation Intervention

An interventional study of EMPOWER in Cancer, sponsored by Wake Forest University Health Sciences. Completed at 3 sites in United States. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care

Phase: Not applicable
Study type: Interventional
Enrollment: 352
Allocation: Randomized
Ages: 15 Years to 39 Years
Sex: All

Study 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.

Read the detailed 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 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.

Conditions studied

Cancer

Browse trials for

Neoplasms 9,365

Keywords

Adolescents
Young Adults
Post-treatment cancer survivors

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 352 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 15 Years to 39 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Supportive care
Allocation: Randomized
Intervention model: Factorial assignment
Masking: None (open label)
Enrollment: 352 participants (actual)

Study arms

Experimental
Arm 1 No PE, No M, No PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 2 No PE, No M, No PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 3 No PE, No M, No PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 4 No PE, No M, No PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 5 No PE, No M, Yes PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 6 No PE, No M, Yes PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 7 No PE, No M, Yes PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 9 No PE, Yes M, No PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 10 No PE, Yes M, No PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 11 No PE, Yes M, No PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 13 No PE, Yes M, Yes PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 17 Yes PE, No M, No PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 18 Yes PE, No M, No PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 19 Yes PE, No M, No PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 21 Yes PE, No M, Yes PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 25 Yes PE, Yes M, No PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK
Behavioral: EMPOWER
Experimental
Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK
Behavioral: EMPOWER
Experimental
Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK
Behavioral: EMPOWER
Experimental
Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK
Behavioral: EMPOWER

Interventions

BehavioralEMPOWER
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.

What researchers measure

Primary outcomes

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)

Secondary outcomes

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
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)

Results

Posted Jul 9, 2026

Participant flow

Participant flow — Overall Study
Milestone	Arm 1 No PE, No M, No PR, No PS, No AK	Arm 2 No PE, No M, No PR, No PS, Yes AK	Arm 3 No PE, No M, No PR, Yes PS, No AK	Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Arm 5 No PE, No M, Yes PR, No PS, No AK	Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Arm 9 No PE, Yes M, No PR, No PS, No AK	Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Arm 17 Yes PE, No M, No PR, No PS, No AK	Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Arm 19 Yes PE, No M, No PR, Yes PS, No AK	Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK
Started	12	12	12	12	12	11	11	12	10	11	12	10	11	13	11	10	11	11	10	11	10	11	10	11	11	11	10	10	12	10	11	10
Completed	8	9	9	10	10	11	8	8	5	8	8	8	2	10	5	7	8	9	7	7	9	8	8	10	9	8	7	5	8	8	6	8
Not completed	4	3	3	2	2	0	3	4	5	3	4	2	9	3	6	3	3	2	3	4	1	3	2	1	2	3	3	5	4	2	5	2

Outcome measures

PrimaryT0 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)
Reported as:: Least squares mean · T-score

T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
T-score	Group 1: Positive Events, Capitalizing, Gratitude (Intervention Content) in Week 1	Group 2: Cognitive Skills (Control Content) in Week 1	Group 3: Mindfulness (Intervention Content) in Week 2	Group 4: Financial Literacy (Control Content) in Week 2	Group 5: Positive Reappraisal (Intervention Content) in Week 3	Group 6: Nutrition (Control Content) in Week 3	Group 7: Personal Strengths/Goal-setting (Intervention Content) in Week 4	Group 8: Weight Management (Control Content) in Week 4	Group 9: Acts of Kindness (Intervention Content) in Week 5	Group 10: Sun Protection (Control Intervention) in Week 5
Estimated T-scores at T0	46.2 ± 0.7	45.3 ± 0.7	46.0 ± 0.7	45.6 ± 0.6	46.4 ± 0.7	45.1 ± 0.7	45.8 ± 0.7	45.7 ± 0.7	45.8 ± 0.7	45.7 ± 0.7
Estimated T-scores at T6	47.7 ± 0.8	46.7 ± 0.8	47.4 ± 0.8	47.0 ± 0.7	47.4 ± 0.7	47.0 ± 0.8	47.7 ± 0.8	46.7 ± 0.7	46.9 ± 0.7	47.4 ± 0.8

SecondaryT0 and T6 Anxiety T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT) Questionnaire

Time frame:: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
Reported as:: Least squares mean · T-score

T0 and T6 Anxiety T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Computer Adaptive Test (CAT) Questionnaire
T-score	Group 1: Positive Events, Capitalizing, Gratitude (Intervention Content) in Week 1	Group 2: Cognitive Skills (Control Content) in Week 1	Group 3: Mindfulness (Intervention Content) in Week 2	Group 4: Financial Literacy (Control Content) in Week 2	Group 5: Positive Reappraisal (Intervention Content) in Week 3	Group 6: Nutrition (Control Content) in Week 3	Group 7: Personal Strengths/Goal-setting (Intervention Content) in Week 4	Group 8: Weight Management (Control Content) in Week 4	Group 9: Acts of Kindness (Intervention Content) in Week 5	Group 10: Sun Protection (Control Intervention) in Week 5
Estimated T-scores at T0	57.3 ± 0.6	57.1 ± 0.6	56.6 ± 0.6	57.7 ± 0.6	56.1 ± 0.6	58.3 ± 0.6	56.9 ± 0.6	57.5 ± 0.6	56.8 ± 0.6	57.6 ± 0.6
Estimated T-scores at T6	55.3 ± 0.7	56.2 ± 0.7	55.1 ± 0.7	56.4 ± 0.6	55.1 ± 0.7	56.4 ± 0.7	55.3 ± 0.7	56.2 ± 0.7	55.6 ± 0.6	56.0 ± 0.7

SecondaryT0 and T6 Depression T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire

Time frame:: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
Reported as:: Least squares mean · T-score

T0 and T6 Depression T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire
T-score	Group 1: Positive Events, Capitalizing, Gratitude (Intervention Content) in Week 1	Group 2: Cognitive Skills (Control Content) in Week 1	Group 3: Mindfulness (Intervention Content) in Week 2	Group 4: Financial Literacy (Control Content) in Week 2	Group 5: Positive Reappraisal (Intervention Content) in Week 3	Group 6: Nutrition (Control Content) in Week 3	Group 7: Personal Strengths/Goal-setting (Intervention Content) in Week 4	Group 8: Weight Management (Control Content) in Week 4	Group 9: Acts of Kindness (Intervention Content) in Week 5	Group 10: Sun Protection (Control Intervention) in Week 5
Estimated T0 T-scores	51.6 ± 0.6	51.3 ± 0.6	50.8 ± 0.6	52.1 ± 0.6	50.9 ± 0.6	52.1 ± 0.6	51.2 ± 0.6	51.7 ± 0.6	51.5 ± 0.6	51.5 ± 0.6
Estimated T6 T-scores	51.6 ± 0.6	50.7 ± 0.6	50.9 ± 0.7	51.4 ± 0.6	51.3 ± 0.6	51.1 ± 0.6	51.0 ± 0.6	51.3 ± 0.6	51.2 ± 0.6	51.2 ± 0.7

SecondaryT0 and T6 Life Satisfaction T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire

Time frame:: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
Reported as:: Least squares mean · T-score

T0 and T6 Life Satisfaction T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire
T-score	Group 1: Positive Events, Capitalizing, Gratitude (Intervention Content) in Week 1	Group 2: Cognitive Skills (Control Content) in Week 1	Group 3: Mindfulness (Intervention Content) in Week 2	Group 4: Financial Literacy (Control Content) in Week 2	Group 5: Positive Reappraisal (Intervention Content) in Week 3	Group 6: Nutrition (Control Content) in Week 3	Group 7: Personal Strengths/Goal-setting (Intervention Content) in Week 4	Group 8: Weight Management (Control Content) in Week 4	Group 9: Acts of Kindness (Intervention Content) in Week 5	Group 10: Sun Protection (Control Intervention) in Week 5
Estimated T0 T-Scores	49.2 ± 0.8	47.9 ± 0.8	49.3 ± 0.8	47.9 ± 0.8	49.4 ± 0.8	47.7 ± 0.8	48.7 ± 0.8	50.5 ± 0.8	48.7 ± 0.8	48.4 ± 0.8
Estimated T6 T-Scores	50.2 ± 0.8	49.5 ± 0.8	50.6 ± 0.8	49.0 ± 0.8	50.4 ± 0.8	49.2 ± 0.8	48.4 ± 0.8	49.2 ± 0.8	49.6 ± 0.8	50.1 ± 0.8

Adverse events

Collected over From day immediately following date of randomization until 4 months post intervention. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Arm 1, Week 2 (Financial Literacy Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 2, Week 2 (Financial Literacy Content)	0/12 (0%)	0/12 (0%)	2/12 (16.7%)
Arm 2, Followup	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 3, Week 2 (Financial Literacy Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 4, Week 1 (Cognitive Changes Content)	0/12 (0%)	0/12 (0%)	2/12 (16.7%)
Arm 4, Week 3 (Nutrition Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 4, Followup	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 5, Week 2 (Financial Literacy Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 5, Followup	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 6, Week 1(Cognitive Changes Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 6, Followup	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 7, Week 1 (Cognitive Changes Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 7, Week 3 (Positive Reappraisal Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 7, Followup	0/11 (0%)	0/11 (0%)	2/11 (18.2%)
Arm 8, Week 4 (Personal Strengths Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 8, Week 5 (Acts of Kindness Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 9, Week 1 (Cognitive Changes Content)	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 9, Week 5 (Sun Protection Content)	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 10, Week 1 (Cognitive Changes Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 10, Week 3 (Nutrition Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 10, Followup	0/11 (0%)	0/11 (0%)	2/11 (18.2%)
Arm 11, Week 5 (Sun Protection Content)	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 12, Followup	0/10 (0%)	0/10 (0%)	2/10 (20%)
Arm 14, Week 2 (Mindfulness Content)	0/13 (0%)	0/13 (0%)	1/13 (7.7%)
Arm 14, Week 3 (Positive Reappraisal Content)	0/13 (0%)	0/13 (0%)	1/13 (7.7%)
Arm 16, Week 1 (Cognitive Changes Content)	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 17, Week 2 (Financial Literacy Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 17, Week 4 (Weight Management Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 18, Week 4 (Weight Management Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 19, Followup	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 20, Week 1 (Gratitude Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 20, Week 4 (Personal Strengths Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 20, Followup	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 21, Week 1 (Gratitude Content)	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 22, Week 4 (Weight Management Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 22, Followup	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 24, Week 5 (Kindness Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 24, Followup	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 25, Week 2 (Mindfulness Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 25, Week 5 (Sun Protection Content)	0/11 (0%)	0/11 (0%)	1/11 (9.1%)
Arm 29, Followup	0/12 (0%)	0/12 (0%)	1/12 (8.3%)
Arm 30, Followup	0/10 (0%)	0/10 (0%)	1/10 (10%)
Arm 32, Followup	0/10 (0%)	0/10 (0%)	1/10 (10%)

Most frequent other events

Most frequent other events
Event	Arm 1, Week 2 (Financial Literacy Content)	Arm 2, Week 2 (Financial Literacy Content)	Arm 2, Followup	Arm 3, Week 2 (Financial Literacy Content)	Arm 4, Week 1 (Cognitive Changes Content)	Arm 4, Week 3 (Nutrition Content)	Arm 4, Followup	Arm 5, Week 2 (Financial Literacy Content)	Arm 5, Followup	Arm 6, Week 1(Cognitive Changes Content)	Arm 6, Followup	Arm 7, Week 1 (Cognitive Changes Content)	Arm 7, Week 3 (Positive Reappraisal Content)	Arm 7, Followup	Arm 8, Week 4 (Personal Strengths Content)	Arm 8, Week 5 (Acts of Kindness Content)	Arm 9, Week 1 (Cognitive Changes Content)	Arm 9, Week 5 (Sun Protection Content)	Arm 10, Week 1 (Cognitive Changes Content)	Arm 10, Week 3 (Nutrition Content)	Arm 10, Followup	Arm 11, Week 5 (Sun Protection Content)	Arm 12, Followup	Arm 14, Week 2 (Mindfulness Content)	Arm 14, Week 3 (Positive Reappraisal Content)	Arm 16, Week 1 (Cognitive Changes Content)	Arm 17, Week 2 (Financial Literacy Content)	Arm 17, Week 4 (Weight Management Content)	Arm 18, Week 4 (Weight Management Content)	Arm 19, Followup	Arm 20, Week 1 (Gratitude Content)	Arm 20, Week 4 (Personal Strengths Content)	Arm 20, Followup	Arm 21, Week 1 (Gratitude Content)	Arm 22, Week 4 (Weight Management Content)	Arm 22, Followup	Arm 24, Week 5 (Kindness Content)	Arm 24, Followup	Arm 25, Week 2 (Mindfulness Content)	Arm 25, Week 5 (Sun Protection Content)	Arm 29, Followup	Arm 30, Followup	Arm 32, Followup
T-score >70 for PROMIS Anxiety and/or DepressionPsychiatric disorders	1/12	2/12	1/12	1/12	2/12	1/12	1/12	1/12	1/12	1/11	1/11	1/11	1/11	2/11	1/12	1/12	1/10	1/10	1/11	1/11	2/11	1/12	2/10	1/13	1/13	1/10	1/11	1/11	1/11	1/10	1/11	1/11	1/11	1/10	1/11	1/11	1/11	1/11	1/11	1/11	1/12	1/10	1/10

Baseline characteristics

Age, Continuous
Age, Continuous(Years)	Arm 1 No PE, No M, No PR, No PS, No AK	Arm 2 No PE, No M, No PR, No PS, Yes AK	Arm 3 No PE, No M, No PR, Yes PS, No AK	Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Arm 5 No PE, No M, Yes PR, No PS, No AK	Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Arm 9 No PE, Yes M, No PR, No PS, No AK	Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Arm 17 Yes PE, No M, No PR, No PS, No AK	Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Arm 19 Yes PE, No M, No PR, Yes PS, No AK	Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK	Total
Mean	31.3 ± 5.9	32.7 ± 5.2	30.7 ± 6.3	34.0 ± 3.9	32.3 ± 6.2	32.7 ± 5.7	30.6 ± 5.3	35.1 ± 3.3	32.8 ± 4.0	33.3 ± 5.0	34.4 ± 4.8	31.5 ± 6.5	32.9 ± 5.6	35.2 ± 4.9	32.7 ± 6.6	33.1 ± 5.1	30.4 ± 5.9	29.8 ± 5.9	30.2 ± 4.9	29.5 ± 7.5	30.1 ± 7.0	32.8 ± 5.5	31.8 ± 5.9	32.1 ± 4.8	34.1 ± 4.7	30.4 ± 7.1	32.7 ± 5.9	33.3 ± 5.1	31.9 ± 6.4	32.0 ± 6.4	30.0 ± 6.4	33.0 ± 5.9	32.2 ± 5.6

Sex: Female, Male
Sex: Female, Male(Participants)	Arm 1 No PE, No M, No PR, No PS, No AK	Arm 2 No PE, No M, No PR, No PS, Yes AK	Arm 3 No PE, No M, No PR, Yes PS, No AK	Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Arm 5 No PE, No M, Yes PR, No PS, No AK	Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Arm 9 No PE, Yes M, No PR, No PS, No AK	Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Arm 17 Yes PE, No M, No PR, No PS, No AK	Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Arm 19 Yes PE, No M, No PR, Yes PS, No AK	Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK	Total
Female	11	11	9	8	10	8	10	11	8	5	11	6	8	11	9	7	8	6	8	11	7	6	7	5	7	8	7	8	9	8	8	7	263
Male	1	1	3	4	2	3	1	1	2	6	1	4	3	2	2	3	3	5	2	0	3	5	3	6	4	3	3	2	3	2	3	3	89

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Arm 1 No PE, No M, No PR, No PS, No AK	Arm 2 No PE, No M, No PR, No PS, Yes AK	Arm 3 No PE, No M, No PR, Yes PS, No AK	Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Arm 5 No PE, No M, Yes PR, No PS, No AK	Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Arm 9 No PE, Yes M, No PR, No PS, No AK	Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Arm 17 Yes PE, No M, No PR, No PS, No AK	Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Arm 19 Yes PE, No M, No PR, Yes PS, No AK	Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK	Total
Black	1	2	3	1	3	1	2	1	0	0	2	0	1	1	1	1	1	2	0	1	3	1	1	1	2	1	1	1	1	0	1	0	37
White	9	10	7	9	8	10	9	9	5	8	9	8	9	11	6	9	6	8	9	8	6	10	7	9	9	9	8	7	10	9	10	9	270
Other (non-Black. non-White)	2	0	2	2	1	0	0	2	5	3	1	2	1	1	4	0	4	1	1	2	1	0	2	1	0	1	1	2	1	1	0	1	45

Site
Site(Participants)	Arm 1 No PE, No M, No PR, No PS, No AK	Arm 2 No PE, No M, No PR, No PS, Yes AK	Arm 3 No PE, No M, No PR, Yes PS, No AK	Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Arm 5 No PE, No M, Yes PR, No PS, No AK	Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Arm 9 No PE, Yes M, No PR, No PS, No AK	Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Arm 17 Yes PE, No M, No PR, No PS, No AK	Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Arm 19 Yes PE, No M, No PR, Yes PS, No AK	Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK	Total
Site: WFB/other	3	4	4	3	4	3	3	3	2	3	4	2	3	4	2	2	3	3	2	3	2	2	2	3	3	3	2	2	4	1	3	2	89
Site: Northwestern	7	6	6	7	6	6	6	7	6	6	6	6	6	7	6	6	6	6	6	6	6	6	6	6	6	6	6	6	6	6	6	6	196
Site: MD Anderson	1	1	1	1	1	1	1	1	1	1	1	1	1	1	2	1	1	1	1	1	1	2	1	1	1	1	1	1	1	2	1	1	35
Site: Levine Cancer Institute/Hospital	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	1	32

Study locations

3 sites

Northwestern University Feinberg School of Medicine
Chicago, Illinois 60611, United States
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina 27157, United States
MD Anderson Cancer Center
Houston, Texas 77030, United States

References and documents

Publications

Salsman JM, Murphy KM, Addington EL, Tooze JA, McLouth LE, Yang D, Sanford S, Wagner L, Bunch SC, Rosenberg AR, Valle CG, Zebrack B, Howard D, Roth M, Moskowitz JT. Optimization of a digital health intervention to enhance well-being among adolescent and young adult cancer survivors: Design and methods of the EMPOWER full factorial trial. Contemp Clin Trials. 2025 Feb;149:107783. doi: 10.1016/j.cct.2024.107783. Epub 2024 Dec 20. PubMed 39710338 ↗

Study documents

Protocol and statistical analysis plan · Jan 23, 2024
Informed consent form · May 10, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04317417
Lead sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Mar 23, 2020
Start date: Jan 6, 2022
Primary completion: Apr 30, 2025
Completion: Apr 30, 2025
Results posted: Jul 9, 2026
Last update: Jul 9, 2026

Study contacts

John M Salsman, Ph.D

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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