NCT04317417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
352

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 6, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

3.3 years

First QC Date

March 19, 2020

Last Update Submit

September 11, 2025

Conditions

Keywords

AdolescentsYoung AdultsPost-treatment cancer survivors

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire

    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.

    Baseline up to 4 months after intervention

Secondary Outcomes (3)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire

    Baseline up to 4 months after intervention

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire

    Baseline up to 4 months after intervention

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire

    Baseline up to 4 months after intervention

Study Arms (32)

Condition 1

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 2

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 3

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 4

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 5

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 6

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 7

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 8

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 9

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 10

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 11

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 12

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 13

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 14

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 15

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 16

EXPERIMENTAL

1\) Cognitive Changes after Cancer, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 17

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 18

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 19

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 20

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 21

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 22

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 23

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 24

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 25

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Diet, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 26

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 27

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 28

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Weight Management, 4) Strengths/Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 29

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Sun Protection

Behavioral: EMPOWER

Condition 30

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Financial Literacy and 5) Acts of Kindness

Behavioral: EMPOWER

Condition 31

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Sun Protection

Behavioral: EMPOWER

Condition 32

EXPERIMENTAL

1\) Positive Events, Capitalizing and Gratitude, 2) Mindfulness, 3) Positive Reappraisal , 4) Strengths/ Achievable Goals and 5) Acts of Kindness

Behavioral: EMPOWER

Interventions

EMPOWERBEHAVIORAL

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.

Condition 1Condition 10Condition 11Condition 12Condition 13Condition 14Condition 15Condition 16Condition 17Condition 18Condition 19Condition 2Condition 20Condition 21Condition 22Condition 23Condition 24Condition 25Condition 26Condition 27Condition 28Condition 29Condition 3Condition 30Condition 31Condition 32Condition 4Condition 5Condition 6Condition 7Condition 8Condition 9

Eligibility Criteria

Age15 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Able to read and understand English
  • Past history of a cancer diagnosis (excluding basal cell skin carcinoma)
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

  • John M Salsman, Ph.D

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

January 6, 2022

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations