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Trial Title:
Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit
NCT ID:
NCT06420193
Condition:
Depression
Cancer
Adolescent
Young Adult
Adult
Conditions: Official terms:
Depression
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Supportive Care
Masking:
Single (Participant)
Intervention:
Intervention type:
Behavioral
Intervention name:
AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
Description:
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.
Arm group label:
Condition 1
Arm group label:
Condition 10
Arm group label:
Condition 11
Arm group label:
Condition 12
Arm group label:
Condition 13
Arm group label:
Condition 14
Arm group label:
Condition 15
Arm group label:
Condition 16
Arm group label:
Condition 2
Arm group label:
Condition 3
Arm group label:
Condition 4
Arm group label:
Condition 5
Arm group label:
Condition 6
Arm group label:
Condition 7
Arm group label:
Condition 8
Arm group label:
Condition 9
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
15 Years
Maximum age:
39 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
East Carolina University
Address:
City:
Greenville
Zip:
27858
Country:
United States
Status:
Recruiting
Contact:
Last name:
AnneMarie Coffey
Phone:
252-328-6244
Email:
coffeya23@ecu.edu
Contact backup:
Last name:
Karly M Murphy, PhD
Phone:
252-737-4638
Email:
murphykar22@ecu.edu
Contact backup:
Last name:
Karly M Murphy, PhD
Start date:
October 1, 2024
Completion date:
December 2024
Lead sponsor:
Agency:
East Carolina University
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
East Carolina University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06420193
