MOST EMPOWER: Optimizing An Emotion Regulation Intervention

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Recruiting
CT.gov ID
NCT04317417
Collaborator
National Cancer Institute (NCI) (NIH)
352
2
32
31.8
176
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: EMPOWER
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
352 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Using MOST to EMPOWER: Optimizing an Emotion Regulation Intervention to Enhance Well-being Among Adolescents and Young Adult Cancer Survivors
Actual Study Start Date :
Jan 6, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Condition 1

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

Behavioral: EMPOWER
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.

Experimental: Condition 2

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

Behavioral: EMPOWER
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.

Experimental: Condition 3

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

Behavioral: EMPOWER
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.

Experimental: Condition 4

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

Behavioral: EMPOWER
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.

Experimental: Condition 5

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

Behavioral: EMPOWER
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.

Experimental: Condition 6

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

Behavioral: EMPOWER
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.

Experimental: Condition 7

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

Behavioral: EMPOWER
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.

Experimental: Condition 8

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

Behavioral: EMPOWER
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.

Experimental: Condition 9

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

Behavioral: EMPOWER
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.

Experimental: Condition 10

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

Behavioral: EMPOWER
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.

Experimental: Condition 11

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

Behavioral: EMPOWER
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.

Experimental: Condition 12

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

Behavioral: EMPOWER
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.

Experimental: Condition 13

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

Behavioral: EMPOWER
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.

Experimental: Condition 14

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

Behavioral: EMPOWER
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.

Experimental: Condition 15

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

Behavioral: EMPOWER
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.

Experimental: Condition 16

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

Behavioral: EMPOWER
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.

Experimental: Condition 17

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

Behavioral: EMPOWER
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.

Experimental: Condition 18

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

Behavioral: EMPOWER
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.

Experimental: Condition 19

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

Behavioral: EMPOWER
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.

Experimental: Condition 20

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

Behavioral: EMPOWER
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.

Experimental: Condition 21

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

Behavioral: EMPOWER
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.

Experimental: Condition 22

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

Behavioral: EMPOWER
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.

Experimental: Condition 23

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

Behavioral: EMPOWER
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.

Experimental: Condition 24

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

Behavioral: EMPOWER
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.

Experimental: Condition 25

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

Behavioral: EMPOWER
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.

Experimental: Condition 26

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

Behavioral: EMPOWER
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.

Experimental: Condition 27

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

Behavioral: EMPOWER
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.

Experimental: Condition 28

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

Behavioral: EMPOWER
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.

Experimental: Condition 29

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

Behavioral: EMPOWER
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.

Experimental: Condition 30

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

Behavioral: EMPOWER
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.

Experimental: Condition 31

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

Behavioral: EMPOWER
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.

Experimental: Condition 32

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

Behavioral: EMPOWER
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.

Outcome Measures

Primary Outcome Measures

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire [Baseline up to 4 months after intervention]

    Participants will complete a self-reported questionnaire on psychological wellbeing 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. Higher scores indicate more of the underlying construct.

Secondary Outcome Measures

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Questionnaire [Baseline up to 4 months after intervention]

    Participants will complete a self-reported questionnaire to capture the negative aspects of anxiety in the past seven days. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Questionnaire [Baseline up to 4 months after intervention]

    Participants will complete a self-reported questionnaire to capture the negative aspects of depression over the past seven days. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Life Satisfaction Questionnaire [Baseline up to 4 months after intervention]

    Participants will complete a self-reported questionnaire to capture the positive (life satisfaction) aspects of emotional health. Raw scores will be converted to T-scores with a mean of 50 and a standard deviation of 10. Higher scores indicate more of the underlying construct.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 39 Years
Sexes Eligible for Study:
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:
  • Ever been hospitalized for a psychiatric illness

  • Currently receiving palliative or hospice care

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwestern University Feinberg School of Medicine Chicago Illinois United States 60611
2 Wake Forest Baptist Comprehensive Cancer Center Winston-Salem North Carolina United States 27157

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: John M Salsman, Ph.D, Wake Forest University Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT04317417
Other Study ID Numbers:
  • IRB00057993
  • WFBCCC 04220
  • R01CA242849-01
First Posted:
Mar 23, 2020
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wake Forest University Health Sciences

Study Results

No Results Posted as of Jun 16, 2022