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NCT Number: NCT07173205

Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit

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.

Recruiting

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Key information

Conditions

Depression Adolescent Adult Behavior Behavioral Symptoms Cancer Neoplasms Young Adult

Age range

15 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East Carolina University, Greenville, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Behavioral

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.

Primary outcomes

  1. Change in Depressive Symptoms during Intervention Period

    Time frame: 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 outcomes

  1. Change in Depressive Symptoms at follow-up

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

AnneMarie Coffey, BS

CONTACT

[email protected]

252-328-6244

Lane Williamson

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

East Carolina University

Other

Collaborators

  • National Cancer Institute (NCI)
  • Wake Forest University Health Sciences

Registry information

Official study title

R00 Full Factorial Trial: Optimizing ASCENT

Acronym: ASCENT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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