CancerMOST EMPOWERNCT04317417

MOST EMPOWER: Optimizing An Emotion Regulation Intervention

A study testing EMPOWER in people with Cancer, run by Wake Forest University Health Sciences at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 15 to 39 years
Conditions the study is for: Cancer
What is being tested?: EMPOWER
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 352 participants
Where: 3 sitesUnited States
Study dates: 6 Jan 2022to 30 Apr 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 39 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

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About this study

Official title: Using MOST to EMPOWER: Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors

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: Cancer
Being tested: EMPOWER
Keywords: Adolescents, Young Adults, Post-treatment cancer survivors
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EMPOWERBehavioural
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.

Study groups in NCT04317417
Study group	Role	What they receive
Arm 1 No PE, No M, No PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 2 No PE, No M, No PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 3 No PE, No M, No PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 4 No PE, No M, No PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 5 No PE, No M, Yes PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 6 No PE, No M, Yes PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 7 No PE, No M, Yes PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 8 No PE, No M, Yes PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 9 No PE, Yes M, No PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 10 No PE, Yes M, No PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 11 No PE, Yes M, No PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 12 No PE, Yes M, No PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 13 No PE, Yes M, Yes PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 14 No PE, Yes M, Yes PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 15 No PE, Yes M, Yes PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 16 No PE, Yes M, Yes PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 17 Yes PE, No M, No PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 18 Yes PE, No M, No PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 19 Yes PE, No M, No PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 20 Yes PE, No M, No PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 21 Yes PE, No M, Yes PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 22 Yes PE, No M, Yes PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 23 Yes PE, No M, Yes PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 24 Yes PE, No M, Yes PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 25 Yes PE, Yes M, No PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 26 Yes PE, Yes M, No PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 27 Yes PE, Yes M, No PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 28 Yes PE, Yes M, No PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 29 Yes PE, Yes M, Yes PR, No PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 30 Yes PE, Yes M, Yes PR, No PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 31 Yes PE, Yes M, Yes PR, Yes PS, No AK	Experimental	Not described Receives: Behavioral: EMPOWER
Arm 32 Yes PE, Yes M, Yes PR, Yes PS, Yes AK	Experimental	Not described Receives: Behavioral: EMPOWER

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)

Secondary outcomes (3)

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.
Measured: 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.
Measured: 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.
Measured: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 202230 Apr 2025

First posted23 Mar 2020
Study start6 Jan 2022
Primary completion30 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 352 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04317417
Sponsor's protocol ID: IRB00057993
Other IDs: WFBCCC 04220, R01CA242849-01
Acronym: MOST EMPOWER
Status last verified: Jun 2026
First submitted: 19 Mar 2020
Last updated: 9 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Using MOST to EMPOWER: Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors
ClinicalTrials.gov ID: NCT04317417
Acronym / sponsor ID: MOST EMPOWER / IRB00057993
Conditions: Cancer
Keywords: Adolescents, Young Adults, Post-treatment cancer survivors
Study type: Interventional
Recruitment status: Completed
Enrolment: 352 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 6 Jan 2022 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 23 Mar 2020 (actual)
Results: Posted 9 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 32

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

Who may qualify

Ages: 15 to 39 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EMPOWERParticipants 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.	Behavioural	Arm 1 No PE, No 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, No PS, Yes AK, Arm 2 No PE, No M, No PR, No PS, Yes 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 3 No PE, No M, No PR, Yes 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, 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

Primary outcome

T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)
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.

3 secondary outcomes

T0 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)
T0 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)
T0 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)

Results and safety

Results posted to the registry on 9 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

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

Primary outcome: T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire

Time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6). Least squares mean (Standard Error). Unit: T-score

Measure	Group 1: Positive Events, Capitalizing, Gratitude (Intervention Content) in Week 1 n = 170	Group 2: Cognitive Skills (Control Content) in Week 1 n = 182	Group 3: Mindfulness (Intervention Content) in Week 2 n = 173	Group 4: Financial Literacy (Control Content) in Week 2 n = 179	Group 5: Positive Reappraisal (Intervention Content) in Week 3 n = 176	Group 6: Nutrition (Control Content) in Week 3 n = 176	Group 7: Personal Strengths/Goal-setting (Intervention Content) in Week 4 n = 173	Group 8: Weight Management (Control Content) in Week 4 n = 179	Group 9: Acts of Kindness (Intervention Content) in Week 5 n = 176	Group 10: Sun Protection (Control Intervention) in Week 5 n = 176
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)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From day immediately following date of randomization until 4 months post intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1, Week 2 (Financial Literacy Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 2, Week 2 (Financial Literacy Content)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Arm 2, Followup	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 3, Week 2 (Financial Literacy Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 4, Week 1 (Cognitive Changes Content)	0 of 12 (0%)	2 of 12 (16.7%)	0 of 12
Arm 4, Week 3 (Nutrition Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 4, Followup	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 5, Week 2 (Financial Literacy Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 5, Followup	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 6, Week 1(Cognitive Changes Content)	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Arm 6, Followup	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Arm 7, Week 1 (Cognitive Changes Content)	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Arm 7, Week 3 (Positive Reappraisal Content)	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Arm 7, Followup	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Arm 8, Week 4 (Personal Strengths Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 8, Week 5 (Acts of Kindness Content)	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12
Arm 9, Week 1 (Cognitive Changes Content)	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Arm 9, Week 5 (Sun Protection Content)	0 of 10 (0%)	1 of 10 (10%)

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39710338Salsman 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

John M Salsman, Ph.D principal investigator

Wake Forest University Health Sciences

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EMPOWER in people with Cancer, run by Wake Forest University Health Sciences at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire (time frame: At baseline (T0) and at intervention completion 10 weeks after baseline (T6)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317417, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.