Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-39
SponsorEast Carolina University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Mental Health: Current diagnosis of severe or persistent mental illness
Suicidality: Severe suicidal ideation (including plan and intent)
Trial design
Design model
Factorial
Treatments tested in this trial
AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
BehavioralParticipants 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.
Treatment groups
208 Participants
are divided into 16 treatment groups16
Treatment groupsSee each treatment group below.
Group A: Condition 1Experimental treatment 1 intervention
Group B: Condition 2Experimental treatment 1 intervention
Group C: Condition 3Experimental treatment 1 intervention
Group D: Condition 4Experimental treatment 1 intervention
Group E: Condition 5Experimental treatment 1 intervention
Group F: Condition 6Experimental treatment 1 intervention
Group G: Condition 7Experimental treatment 1 intervention
Group H: Condition 8Experimental treatment 1 intervention
Group I: Condition 9Experimental treatment 1 intervention
Group J: Condition 10Experimental treatment 1 intervention
Group K: Condition 11Experimental treatment 1 intervention
Group L: Condition 12Experimental treatment 1 intervention
Group M: Condition 13Experimental treatment 1 intervention
Group N: Condition 14Experimental treatment 1 intervention
Group O: Condition 15Experimental treatment 1 intervention
Group P: Condition 16Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Depressive Symptoms during Intervention Period
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).
Time frame
Baseline to Week 6Secondary outcomes
1
Change in Depressive Symptoms at follow-up
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).
Time frame
Baseline to Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
East Carolina University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Wake Forest University Health Sciences
Collaborator
Source ClinicalTrials.gov