Coping Toolkit for Depression in Young Cancer Survivors

(ASCENT Trial)

Recruiting at 1 trial location

Overseen By Lane Williamson

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: East Carolina University

Disqualifiers: Severe mental illness, Suicidality

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

208 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool designed to help young cancer survivors manage depression. It incorporates methods such as learning about cancer and depression, practicing mindfulness (focusing on the present), and fostering positive thinking. The researchers aim to identify which parts of the tool most effectively alleviate depressive symptoms. It suits individuals who completed cancer treatment 1 month to 5 years ago, own a smartphone, and face challenges with depression. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could improve mental health support for cancer survivors.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital intervention is safe for adolescent and young adult cancer survivors?

Research has shown that digital tools, such as the AYA Survivors Coping and Emotional Needs Toolkit (ASCENT), can safely and effectively manage depression symptoms, particularly in young cancer survivors. This toolkit addresses emotional challenges using proven methods like mindfulness and positive thinking. These approaches are generally well-tolerated and lack significant side effects, as they focus on psychological support rather than medication.

The ASCENT program includes elements such as education about mental health, changing negative thought patterns, mindfulness, and positive psychology. These methods have succeeded in other settings, yielding good results with minimal risks. They help participants manage their thoughts and feelings without introducing new medications or physical treatments, resulting in a very low risk of side effects compared to drug-based therapies.

Overall, the ASCENT toolkit aims to improve well-being by teaching skills that can help reduce depression symptoms. It offers a supportive and safe option for those seeking to better cope with the emotional aspects of surviving cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASCENT toolkit because it offers a comprehensive approach to tackling depression in young cancer survivors, combining psychoeducation with innovative therapies. Unlike standard treatments that might focus solely on medication or traditional therapy, ASCENT integrates cognitive restructuring, mindfulness training, behavioral activation, and positive psychology. This multifaceted approach helps young survivors not just manage depression but also build resilience and appreciate life, potentially leading to more lasting emotional well-being.

What evidence suggests that this trial's treatments could be effective for depression in young cancer survivors?

Research has shown that young cancer survivors often face mental health challenges, with about one in four experiencing depression. In this trial, participants will receive various components of the ASCENT toolkit, designed to address these issues using several proven methods. Some trial arms will focus on techniques to change negative thoughts, while others will encourage mindfulness to promote presence and acceptance. Additional arms will use activities centered on gratitude and kindness to enhance mood. Studies on digital health tools like ASCENT suggest they can improve mental health for young cancer survivors, making ASCENT a potentially effective way to manage depression. ^{4 6 7 8 9}

Who Is on the Research Team?

Karly M Murphy, PhD

Principal Investigator

East Carolina University

Are You a Good Fit for This Trial?

This trial is for adolescent and young adult cancer survivors who are experiencing symptoms of depression. Participants should be in the age range typically considered adolescence to young adulthood, but specific age ranges aren't provided.

Inclusion Criteria

I was diagnosed with my condition between the ages of 12 and 39.

Language: Fluent in English (spoken and written)

Technology: Own smart phone with data plan

Exclusion Criteria

Current diagnosis of severe or persistent mental illness

I have severe thoughts of harming myself, including a plan and intent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the digital intervention components to manage symptoms of depression

6 weeks

Follow-up

Participants are monitored for changes in depressive symptoms after the intervention

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)

Trial Overview The study tests a digital tool called ASCENT designed to help manage depression in young cancer survivors. It includes psychoeducation and four other components based on proven interventions for depression, aiming to find which parts or combinations improve depressive symptoms.

How Is the Trial Designed?

Group I: Condition 9 Experimental Treatment 1 Intervention

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).

Group II: Condition 8 Experimental Treatment 1 Intervention

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)

Group III: Condition 7 Experimental Treatment 1 Intervention

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).

Group IV: Condition 6 Experimental Treatment 1 Intervention

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).

Group V: Condition 5 Experimental Treatment 1 Intervention

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).

Group VI: Condition 4 Experimental Treatment 1 Intervention

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).

Group VII: Condition 3 Experimental Treatment 1 Intervention

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).

Group VIII: Condition 2 Experimental Treatment 1 Intervention

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).

Group IX: Condition 16 Experimental Treatment 1 Intervention

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)

Group X: Condition 15 Experimental Treatment 1 Intervention

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)

Group XI: Condition 14 Experimental Treatment 1 Intervention

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).

Group XII: Condition 13 Experimental Treatment 1 Intervention

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).

Group XIII: Condition 12 Experimental Treatment 1 Intervention

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).

Group XIV: Condition 11 Experimental Treatment 1 Intervention

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).

Group XV: Condition 10 Experimental Treatment 1 Intervention

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).

Group XVI: Condition 1 Experimental Treatment 1 Intervention

Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).

Who Is Running the Clinical Trial?

East Carolina University

Lead Sponsor

Trials

111

Recruited

42,400+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524059/

Mental health patient‐reported outcomes among adolescents ... Our research question was, how do mental health outcomes, as measured by PROM tools, differ between AYA cancer patients and survivors and their ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.6435

Prevalence and risk of psychological distress, anxiety and ... Our research found that one in three AYA-CS experience psychological distress or anxiety and one in four are affected by depression.

3. ctv.veeva.com ctv.veeva.com/study/optimizing-the-aya-survivors-coping-and-emotional-needs-toolkit

Optimizing the AYA Survivors' Coping and Emotional Needs ... This tool includes one psychoeducation component and four components that are based on evidence-based interventions for depression. The goal of ...

4. ascopubs.org ascopubs.org/doi/10.1200/CCI.17.00138

Digital Health Interventions for Adolescent and Young ... This narrative review describes the evidence regarding digital health interventions targeting adolescent and young adult (AYA) cancer survivors.

5. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2022.872830/full

The Clinical Utility of the Adolescent and Young Adult ... This study demonstrates that the AYA-POST is an appropriate tool in the psychosocial screening of AYAs with cancer, facilitating the identification of distress ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4337625/

Quality of life in adolescent and young adult cancer patients AYA cancer survivors were more likely to have “worse” or impaired QoL compared with the general population, regardless of other demographic factors.

7. chop.edu chop.edu/sites/default/files/2025-08/25ONC-25375X-AYA-Survivorship-Guide-v6.pdf

Psychosocial Services Resource Guide for Adolescent and ... This Resource Guide was created to summarize important resources that may be helpful to adolescent and young adult (AYA) survivors of cancer.

8. mdpi.com mdpi.com/2072-6694/13/19/4847

Adolescent and Young Adult (AYA) Cancer Survivorship ... This article describes the population of AYA cancer survivors according to their epidemiology and late and long-term effects, the challenges and models of AYA ...

9. bloodcancerunited.org bloodcancerunited.org/other-helpful-organizations/patient-and-caregiver-support-and-counseling/young-adults

Young Adults Mission: To provide young cancer survivors who are parents of small children with a safe space for individual and familial healing, recovery, and reconnection.