DepressionASCENTNCT07173205
Optimizing 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 2 sites in United States.
Trial summary
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. 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
- 208 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Oct 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lane Williamson contact
United States2 sites, 2 recruiting
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
AnneMarie Coffey, BS, 252-328-6244, coffeya23@ecu.edu
Karly M Murphy, PhD, 252-737-4638, murphykar22@ecu.edu
- Recruiting
Wake Forest University
Winston-Salem, North Carolina, 27109
Stephanie Bunch, MPH, 336-716-5180, Stephanie.C.Bunch@advocatehealth.org
John Salsman, PhD, jsalsman@wakehealth.edu
About this study
Official title: R00 Full Factorial Trial: Optimizing ASCENT
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.
- Conditions
- Depression, Cancer, Adolescent, Young Adult, Adult
- Being tested
- AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)
- Keywords
- AYA, Adolescent and Young Adult, Cancer Survivorship, Depressive Symptoms, Digital Mental Health, Multiphase Optimization Strategy, Full Factorial Trial
- 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.
Change in Depressive Symptoms during Intervention Period
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).
Measured: Baseline to Week 6
Secondary outcomes (1)
Change in Depressive Symptoms at follow-up
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).
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start25 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences
- 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
- NCT07173205
- Sponsor's protocol ID
- 24-001496
- Other IDs
- R00CA248701
- Acronym
- ASCENT
- Status last verified
- Jan 2026
- First submitted
- 8 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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).
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- R00 Full Factorial Trial: Optimizing ASCENT
- ClinicalTrials.gov ID
- NCT07173205
- Acronym / sponsor ID
- ASCENT / 24-001496
- Conditions
- Depression, Cancer, Adolescent, Young Adult, Adult
- Keywords
- AYA, Adolescent and Young Adult, Cancer Survivorship, Depressive Symptoms, Digital Mental Health, Multiphase Optimization Strategy, Full Factorial Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- East Carolina UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Wake Forest University Health Sciences
- Study start
- 25 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Sep 2025 (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.
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.
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
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).
1 secondary outcome
Change in Depressive Symptoms at follow-up
Time frame: Baseline to Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- 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.
Lane Williamson contact
Karly M Murphy, PhD principal investigator
East Carolina University
2 sites 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 2 sites 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AnneMarie Coffey, BS (252-328-6244, coffeya23@ecu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressive Symptoms during Intervention Period (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026.