NCT06420193

Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit

Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: East Carolina University · Academic / Other
• Sex: All
• Age: 15 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

The investigators developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes daily mood tracking, a psychoeducational module about cancer and depression, four components that are based on evidence-based interventions for depression. The goal of this study is to evaluate the acceptability of procedures for a future trial in which the investigators will test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs. Additionally, the investigators will evaluate study feasibility as well as intervention acceptability, satisfaction, usability, and engagement.

Conditions

• Depression
• Cancer
• Adolescent
• Young Adult
• Adult

Interventions

Type	Name	Description
BEHAVIORAL	AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)	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.

Timeline

• Start date: 2024-10-01
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2024-05-17
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States