Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit
ASCENT
Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
2 other identifiers
interventional
16
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Oct 2024
Shorter than P25 for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2024
CompletedFirst Posted
Study publicly available on registry
May 17, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 17, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 17, 2025
CompletedJuly 10, 2025
July 1, 2025
9 months
May 7, 2024
July 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Acceptability of Study Procedures - Quantitative
An investigator-developed survey will be used to evaluate acceptability of study procedures. Mean scale scores range from 1 to 4, with higher scores indicating greater acceptability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.
Week 6
Acceptability of Study Procedures - Qualitative
An investigator-developed semi-structured interview will be used to evaluate acceptability of study procedures. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of study procedures.
Weeks 6-8
Secondary Outcomes (8)
Study Feasibility - Recruitment Rate
Upon enrollment of 16 participants
Study Feasibility - Retention Rate
Week 6
Intervention Acceptability - Quantitative
Week 6
Intervention Satisfaction - Quantitative
Week 6
Intervention Acceptability & Satisfaction - Qualitative
Weeks 6-8
- +3 more secondary outcomes
Study Arms (16)
Condition 1
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).
Condition 2
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 3
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
Condition 4
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 5
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
Condition 6
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 7
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
Condition 8
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
Condition 9
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values).
Condition 10
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 11
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
Condition 12
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 13
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
Condition 14
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
Condition 15
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance)
Condition 16
EXPERIMENTALFeeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); and Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Mental Health: Current diagnosis of severe or persistent mental illness
- Suicidality: Severe suicidal ideation (including plan and intent)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- East Carolina Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
East Carolina University
Greenville, North Carolina, 27858, United States
Related Publications (1)
Ingram KM, Glock R, Williamson L, Coffey A, Anctil R, Augustinovic A, Yang D, Victorson D, Schoemann AM, Liles D, Salsman JM. Evaluating the feasibility and acceptability of study procedures for a full factorial trial of ASCENT: protocol for a randomized pilot. Pilot Feasibility Stud. 2025 Nov 24;11(1):147. doi: 10.1186/s40814-025-01728-z.
PMID: 41287126DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karly M Murphy, PhD
East Carolina University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 7, 2024
First Posted
May 17, 2024
Study Start
October 1, 2024
Primary Completion
June 17, 2025
Study Completion
June 17, 2025
Last Updated
July 10, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
All de-identified data collected from participants in this study will be preserved and shared in alignment with best practices for open science. Data will be submitted to Dataverse, a free NIH Generalist Repository Ecosystem Initiative (https://dataverse.org/researchers).