DepressionASCENTNCT06420193
Evaluating Procedures for a Study of the AYA Survivors Coping and Emotional Needs Toolkit
A study testing AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) in people with Depression and Cancer, run by East Carolina University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Depression, Cancer, Adolescent
- What is being tested?
- AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Mental Health: Current diagnosis of severe or persistent mental illness
- Suicidality: Severe suicidal ideation (including plan and intent)
Trial locations and contacts
1 site in 1 country.
United States1 site
East Carolina University
Greenville, North Carolina, 27858
About this study
Official title: Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
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
- Being tested
- AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
- Medical subject headings
- Depression, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Condition 1 | Experimental | Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 2 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 3 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 4 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 5 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 6 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 7 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 8 | Experimental | Feeling 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) Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 9 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 10 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 11 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 12 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 13 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 14 | Experimental | Feeling 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). Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 15 | Experimental | Feeling 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) Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
| Condition 16 | Experimental | Feeling 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) Receives: Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weeks 6-8
Secondary outcomes (8)
Study Feasibility - Recruitment Rate
Recruitment rate will be calculated as the number of participants enrolled in the study divided by the number of participants contacted.
Measured: Upon enrollment of 16 participants
Study Feasibility - Retention Rate
Retention will be defined as the proportion of patients who provide T1 (6 week) data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Measured: Week 6
Intervention Acceptability - Quantitative
An investigator-developed survey will be used to evaluate acceptability of the intervention.
Measured: Week 6
Intervention Satisfaction - Quantitative
An investigator-developed survey will be used to evaluate satisfaction with the intervention. Mean scale scores range from 1 to 4, with higher scores indicating greater satisfaction. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.
Measured: Week 6
Intervention Acceptability & Satisfaction - Qualitative
A semi-structured interview will be used to further characterize acceptability of and satisfaction with the intervention. Transcriptions of semi-structured interviews will undergo rapid qualitative analysis to characterize the reasons for sub-optimal acceptability of and satisfaction with the intervention.
Measured: Weeks 6-8
System Usability Scale
The System Usability Scale (SUS) will be administered to evaluate perceived usability of ASCENT. SUS scores range from 0 to 100, with higher scores indicating greater usability. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.
Measured: Week 6
Intervention Adherence
Adherence will be calculated as the percentage of pages viewed by the participant within a module divided by the total number of pages in the module as indicated by metrics from the website. Mean adherence rate and exact 95% confidence intervals (CIs) for each intervention module will be calculated.
Measured: Weeks 1-6
eHealth Engagement Scale
The eHealth Engagement Scale will be administered to evaluate how engaging users found ASCENT engagement. Mean scale scores range from 1 to 4, with lower scores indicating greater engagement. Descriptive statistics and exact 95% confidence intervals (CIs) will be calculated.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Oct 2024
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Karly M Murphy, PhD, East Carolina University
- Investigators
- Karly M Murphy, PhD, Principal investigator, East Carolina University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420193
- Sponsor's protocol ID
- 23-001795
- Other IDs
- R00CA248701
- Acronym
- ASCENT
- Status last verified
- Jul 2025
- First submitted
- 7 May 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 41287126
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Acceptability of Study Procedures for a Full Factorial Trial of the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
- ClinicalTrials.gov ID
- NCT06420193
- Acronym / sponsor ID
- ASCENT / 23-001795
- Conditions
- Depression, Cancer, Adolescent, Young Adult, Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Condition 1 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression). |
| Condition 2 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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 | Experimental | Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)Feeling 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) |
Who may qualify
- Ages
- 15 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Mental Health: Current diagnosis of severe or persistent mental illness
- Suicidality: Severe suicidal ideation (including plan and intent)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Condition 1, Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 2, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8, Condition 9 |
Primary outcome
Acceptability of Study Procedures - Quantitative
Time frame: Week 6
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.
Acceptability of Study Procedures - Qualitative
Time frame: Weeks 6-8
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.
8 secondary outcomes
Study Feasibility - Recruitment Rate
Time frame: Upon enrollment of 16 participants
Study Feasibility - Retention Rate
Time frame: Week 6
Intervention Acceptability - Quantitative
Time frame: Week 6
Intervention Satisfaction - Quantitative
Time frame: Week 6
Intervention Acceptability & Satisfaction - Qualitative
Time frame: Weeks 6-8
System Usability Scale
Time frame: Week 6
Intervention Adherence
Time frame: Weeks 1-6
eHealth Engagement Scale
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 41287126Ingram 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.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karly M Murphy, PhD principal investigator
East Carolina University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) in people with Depression and Cancer, run by East Carolina University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Study Procedures - Quantitative (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06420193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.