Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit

Not Applicable

Not yet recruiting

• Conditions: Depression; Cancer; Adolescent; Young Adult; Adult

• Registration Number: NCT07173205
• Lead Sponsor: East Carolina University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Submitted: 2025-09-17
• Last Update Posted: 2025-09-23
• Study Start: 2025-10-01
• Primary Completion: 2026-07
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 208

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in Depressive Symptoms at follow-up	Baseline to Week 12 and Baseline to Week 24	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).

Trial Locations

Locations (2)

East Carolina University; 🇺🇸 Greenville, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States