Cancer
Conditions
Keywords
Adolescents, Young Adults, Post-treatment cancer survivors
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 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.
Interventions
BEHAVIORALEMPOWER
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.
Sponsors
Wake Forest University Health Sciences
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| T0 and T6 Positive Affect T-Scores--Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Computer Adaptive Test (CAT) Questionnaire | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJohn M Salsman, Ph.D
Wake Forest University Health Sciences
Participant flow
Pre-assignment details
The design of this study is a full factorial design with 5 arms.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.0 Years STANDARD_DEVIATION 5.9 |
| Race/Ethnicity, Customized Black | 2 Participants |
| Race/Ethnicity, Customized Other (non-Black. non-White) | 2 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Sex: Female, Male Female | 263 Participants |
| Sex: Female, Male Male | 1 Participants |
| Site Site: Levine Cancer Institute/Hospital | 1 Participants |
| Site Site: MD Anderson | 35 Participants |
| Site Site: Northwestern | 196 Participants |
| Site Site: WFB/other | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk | EG017 affected / at risk | EG018 affected / at risk | EG019 affected / at risk | EG020 affected / at risk | EG021 affected / at risk | EG022 affected / at risk | EG023 affected / at risk | EG024 affected / at risk | EG025 affected / at risk | EG026 affected / at risk | EG027 affected / at risk | EG028 affected / at risk | EG029 affected / at risk | EG030 affected / at risk | EG031 affected / at risk | EG032 affected / at risk | EG033 affected / at risk | EG034 affected / at risk | EG035 affected / at risk | EG036 affected / at risk | EG037 affected / at risk | EG038 affected / at risk | EG039 affected / at risk | EG040 affected / at risk | EG041 affected / at risk | EG042 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 | 0 / 13 | 0 / 13 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 1 / 12 | 2 / 12 | 1 / 12 | 1 / 12 | 2 / 12 | 1 / 12 | 1 / 12 | 1 / 12 | 1 / 12 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 11 | 2 / 11 | 1 / 12 | 1 / 12 | 1 / 10 | 1 / 10 | 1 / 11 | 1 / 11 | 2 / 11 | 1 / 12 | 2 / 10 | 1 / 13 | 1 / 13 | 1 / 10 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 10 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 10 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 11 | 1 / 12 | 1 / 10 | 1 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 12 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 12 | 0 / 10 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 | 0 / 13 | 0 / 13 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 10 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 11 | 0 / 12 | 0 / 10 | 0 / 10 |
Outcome results
None listed