Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT07173205
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-09-08', 'studyFirstSubmitQcDate': '2025-09-08', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Depressive Symptoms during Intervention Period', 'timeFrame': 'Baseline to Week 6', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Depressive Symptoms at follow-up', 'timeFrame': 'Baseline to Week 12 and Baseline to Week 24', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AYA', 'Adolescent and Young Adult', 'Cancer Survivorship', 'Depressive Symptoms', 'Digital Mental Health', 'Multiphase Optimization Strategy', 'Full Factorial Trial'], 'conditions': ['Depression', 'Cancer', 'Adolescent', 'Young Adult', 'Adult']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '39 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age at enrollment (adolescents 15-17, emerging adults 18-25, young adults 26-39)\n* Age at diagnosis (adolescents 12-17, emerging adults 15-25, young adults 15-39)\n* Time since completion of treatment: 1 month to 5 years\n* Language: Fluent in English (spoken and written)\n* Technology: Own smart phone with data plan\n\nExclusion Criteria:\n\n* Mental Health: Current diagnosis of severe or persistent mental illness\n* Suicidality: Severe suicidal ideation (including plan and intent)'}, 'identificationModule': {'nctId': 'NCT07173205', 'acronym': 'ASCENT', 'briefTitle': "Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit", 'organization': {'class': 'OTHER', 'fullName': 'East Carolina University'}, 'officialTitle': 'R00 Full Factorial Trial: Optimizing ASCENT', 'orgStudyIdInfo': {'id': '24-001496'}, 'secondaryIdInfos': [{'id': 'R00CA248701', 'link': 'https://reporter.nih.gov/quickSearch/R00CA248701', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Condition 1', 'description': 'Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 2', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 3', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 4', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 5', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 6', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 7', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 8', 'description': '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)', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 9', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 10', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 11', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 12', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 13', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 14', 'description': '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).', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 15', 'description': '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)', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}, {'type': 'EXPERIMENTAL', 'label': 'Condition 16', 'description': '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)', 'interventionNames': ['Behavioral: AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)']}], 'interventions': [{'name': 'AYA Survivors Coping and Emotional Needs Toolkit (ASCENT)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill.', 'armGroupLabels': ['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']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27858', 'city': 'Greenville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'AnneMarie Coffey, BS', 'role': 'CONTACT', 'email': 'coffeya23@ecu.edu', 'phone': '252-328-6244'}, {'name': 'Karly M Murphy, PhD', 'role': 'CONTACT', 'email': 'murphykar22@ecu.edu', 'phone': '252-737-4638'}, {'name': 'Karly Murphy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27109', 'city': 'Winston-Salem', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Stephanie Bunch, MPH', 'role': 'CONTACT', 'email': 'Stephanie.C.Bunch@advocatehealth.org', 'phone': '336-716-5180'}, {'name': 'John Salsman, PhD', 'role': 'CONTACT', 'email': 'jsalsman@wakehealth.edu'}], 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'centralContacts': [{'name': 'AnneMarie Coffey, BS', 'role': 'CONTACT', 'email': 'coffeya23@ecu.edu', 'phone': '252-328-6244'}, {'name': 'Lane Williamson', 'role': 'CONTACT', 'email': 'williamsonla24@students.ecu.edu'}], 'overallOfficials': [{'name': 'Karly M Murphy, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'East Carolina University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'ipdSharing': 'YES', 'description': '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).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'East Carolina University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Karly M Murphy, PhD', 'investigatorAffiliation': 'East Carolina University'}}}}