Clinical trial NCT04317417: MOST EMPOWER: Optimizing An Emotion Regulation Intervention
Official title: Using MOST to EMPOWER: Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Adolescents
Young Adults
Post-treatment cancer survivors
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-23
Enrollment: 352
Sex: ALL
Minimum age (years): 15
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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 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 life satisfaction and general self-efficacy 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, general self-efficacy, depression, and anxiety 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, depression, and anxiety.
* 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, depression, and anxiety.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire
timeFrame: Baseline up to 4 months after intervention
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire
timeFrame: Baseline up to 4 months after intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire
timeFrame: Baseline up to 4 months after intervention
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire
timeFrame: Baseline up to 4 months after intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: John M Salsman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: