Adolescent, Adult, Cancer, Depression, Young Adult
Conditions
Keywords
AYA, Adolescent and Young Adult, Cancer Survivorship, Depressive Symptoms, Digital Mental Health, Multiphase Optimization Strategy, Full Factorial Trial
Brief summary
Our team has developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes one psychoeducation component and four components that are based on evidence-based interventions for depression. The goal of this study is to test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs.
Interventions
Participants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill.
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
15 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39) * Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39) * Time since completion of treatment: 1 month to 5 years * Language: Fluent in English (spoken and written) * Technology: Own smart phone with data plan
Exclusion criteria
* Mental Health: Current diagnosis of severe or persistent mental illness * Suicidality: Severe suicidal ideation (including plan and intent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms during Intervention Period | Baseline to Week 6 | The primary outcome for this study is change in depressive symptoms from Baseline to Week 6. In order to be considered for inclusion in the optimized intervention, intervention components must result in a 3-point decrease in T-score on the Patient-Reported Outcomes Measurement Information System (PROMIS)® Computer Adaptive Test (CAT) for depression between W0 and W6. T-scores have a range from 0 to 100, a mean of 50, and a standard deviation of 10. On this measure, higher scores indicate greater depressive symptoms (worse outcome). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms at follow-up | Baseline to Week 12 | The investigators will also evaluate change in depressive symptoms from Week 0 to Week 12 and Week 24 using the Patient-Reported Outcomes Measurement Information System (PROMIS)® Computer Adaptive Test (CAT) for depression. T-scores have a range from 0 to 100, a mean of 50, and a standard deviation of 10. On this measure, higher scores indicate greater depressive symptoms (worse outcome). |
Countries
United States
Contacts
Primary ContactAnneMarie Coffey, BS
Backup ContactLane Williamson
Outcome results
None listed