MOST EMPOWER: Optimizing An Emotion Regulation Intervention

NCT04317417 | Completed Results

• 3 other identifiers: IRB00057993WFBCCC 04220R01CA242849-01
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer

Keywords

Adolescents; Young Adults; Post-treatment cancer survivors

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

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

Study Arms (32)

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

Interventions

EMPOWER BEHAVIORAL

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.

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

Eligibility Criteria

• Age: 15 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

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

Related Publications (1)

• 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.

  PMID: 39710338 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: John Salsman
• Organization: Wake Forest Baptist Comprehensive Cancer Center

john.salsman@wfusm.edu

336-713-3613

Study Officials

• John M Salsman, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: July 9, 2026
• Results First Posted: July 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)