Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2026-04-10 @ 3:11 PM
Study NCT ID:
NCT06434402
Status:
RECRUITING
Last Update Posted:
2025-07-17
First Post:
2024-05-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2024-05-21', 'studyFirstSubmitQcDate': '2024-05-23', 'lastUpdatePostDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Study Completion Rate', 'timeFrame': 'At 1 month follow-up', 'description': 'The Study completion rate is defined as the average proportion of participants who complete follow-up assessments at 1-month follow-up. We will also calculate the 95% confidence intervals for the study completion rate.'}, {'measure': 'Intervention Adherence Rate', 'timeFrame': 'At the end of intervention (week 8)', 'description': 'The intervention adherence rate will be calculated as the number of completed writing tasks divided by the total number of assigned tasks (4).'}], 'secondaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy-General', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': 'The Functional Assessment of Cancer Therapy-General will be used to measure multidimensional quality of life, encompassing physical, social, emotional, and functional well-being, across 27 items. Each item is rated on a 5-point Likert scale ranging from 0 to 4. The overall score can range from 0 to 108, with higher scores indicating a better quality of life.'}, {'measure': 'Perceived Stress', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': "The Perceived Stress scale will be used to measure perceived stress. This 4-item measure assesses the degree to which situations in one's life are appraised as stressful. The overall score can range from 0 to 16, with higher scores indicating higher perceived stress."}, {'measure': 'Coping self-efficacy', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': 'The Cancer Behavior Inventory will be used to measure self-efficacy for coping with cancer. Each item is rated on a 9-point Likert scale. The total score ranges from 9 to 81, with higher scores indicating greater self-efficacy for coping with cancer.'}, {'measure': 'Impact of Event Scale', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': 'The 5-item intrusion subscale of the Impact of Event Scale will be used to assess unwanted thoughts related to cancer. Each item is rated on a 4-point Likert scale. The total score ranges from 0 to 25, with higher scores indicating a greater frequency and intensity of intrusive thoughts.'}, {'measure': 'Common Humanity & Self-Kindness', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': 'Common Humanity and Self-Kindness will be measured using the subscales of the Self-Compassion Scale. These subscales capture positive aspects of self-compassion, including self-kindness (e.g., "When I am going through a very hard time, I give myself the caring and tenderness I need") and common humanity (e.g., "When I am down and out, I remind myself that there are lots of other people in the world feeling like me"). Each item is rated on a 5-point Likert scale. The total score for each subscale ranges from 5 to 25, with higher scores indicating a stronger sense of common humanity and self-kindness.'}, {'measure': 'Posttraumatic growth', 'timeFrame': 'Baseline, and 1- and 3-month follow-up', 'description': 'The Posttraumatic Growth Inventory will be used to assess perceived positive changes as a result of a specific traumatic event. It includes 9 items, each rated on a 6-point Likert scale. The total score ranges from 0 to 45, with higher scores indicating greater perceived posttraumatic growth.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To learn more about the experiences of adolescent and young adult cancer survivors and investigate whether a group-based writing intervention can help to improve quality of life of adolescent and young adult cancer survivors.', 'detailedDescription': 'Primary Objective:\n\nTo evaluate the feasibility of a virtual, group-based expressive writing intervention for survivors of adolescent and young adult cancer.\n\nSecondary Objective:\n\nTo preliminarily assess the impact of the study for cancer survivors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Age 15 - 39 years at cancer diagnosis\n* Age 18 - 39 years at study entry\n* Diagnosed between 1 and 5 years ago prior to enrollment\n* Can speak, read, and write in English\n\nExclusion criteria:\n\n* Nonmelanoma skin cancer\n* Major mental health disorder (e.g., schizophrenia or bipolar disorder \\[determined from patient records or self-disclosure\\])\n* No internet access.'}, 'identificationModule': {'nctId': 'NCT06434402', 'briefTitle': 'A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer', 'orgStudyIdInfo': {'id': '2024-0440'}, 'secondaryIdInfos': [{'id': 'NCI-2024-04531', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emerging adults (ages18-25 years)', 'description': 'Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months.\n\nParticipants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.', 'interventionNames': ['Behavioral: Behavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Young adults (ages 26-39 years)', 'description': 'Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months.\n\nParticipants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.', 'interventionNames': ['Behavioral: Behavioral Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'General group (ages 18-39 years)', 'description': 'Participants complete questionnaires over 20 minutes about their mood, health, and demographic information at baseline, and 1, and 3 months.\n\nParticipants are asked to write about their cancer experiences over 20 minutes (non-stop) for 4 weeks.', 'interventionNames': ['Behavioral: Behavioral Intervention']}], 'interventions': [{'name': 'Behavioral Intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Behavior Condition Therapy', 'Behavior Modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral Treatment'], 'description': 'Write about cancer experiences', 'armGroupLabels': ['Emerging adults (ages18-25 years)', 'General group (ages 18-39 years)', 'Young adults (ages 26-39 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Qian Lu, MD,PHD', 'role': 'CONTACT', 'email': 'qlu@mdanderson.org', 'phone': '713-745-8324'}, {'name': 'Qian Lu, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Qian Lu, MD,PHD', 'role': 'CONTACT', 'email': 'qlu@mdanderson.org', 'phone': '(713) 745-8324'}], 'overallOfficials': [{'name': 'Qian Lu, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}