Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-27 @ 9:09 PM
Study NCT ID:
NCT04058795
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2019-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PTSD Mobile App for Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000682', 'term': 'Amyloid'}], 'ancestors': [{'id': 'D046912', 'term': 'Multiprotein Complexes'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-16', 'size': 230761, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-28T13:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 524}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2019-08-14', 'studyFirstSubmitQcDate': '2019-08-14', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PTSD symptoms measured by the PTSD checklist (PCL5)', 'timeFrame': 'baseline, 4 weeks, 12 weeks', 'description': 'PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"'}], 'secondaryOutcomes': [{'measure': 'Change in distress measured by the Distress Thermometer v. 2018', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': 'Distress Thermometer v. 2018 is a one item instrument scored 0-10, with 0 being "No distress" and 10 being "Extreme distress"'}, {'measure': 'Change in PTSD symptoms measured by the PTSD checklist (PCL5)', 'timeFrame': 'baseline, 12 weeks, 6 months', 'description': 'PCL5 is 20 item instrument scored 0-4, with 0 being "Not at all" and 4 being "Extremely"'}, {'measure': 'Change in Quality of Life measured by the PROMIS QOL', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': 'PROMIS QOL is a 10 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"'}, {'measure': 'Change in depression as measured by the PROMIS', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': 'PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"'}, {'measure': 'Change in anxiety as measured by the PROMIS', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': 'PROMIS is an 8 item instrument scored 1-5, with 1 being "Never" and 5 being "Always"'}, {'measure': 'Change in self-efficacy as measured by the Self-efficacy for Chronic Disease', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': 'Self-efficacy for Chronic Disease is a 6 item instrument scored 1-10, with 1 being "Not at all confident" and 10 being "totally confident"'}, {'measure': 'User satisfaction as measured by a survey', 'timeFrame': 'baseline, 4 weeks, 12 weeks, and 6 months', 'description': "Team developed survey that will include questions regarding the participant's experience"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PTSD', 'Depression', 'Anxiety', 'Distress', 'Digital Health', 'mHealth'], 'conditions': ['Posttraumatic Stress Disorder', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '39141666', 'type': 'DERIVED', 'citation': 'Smith SK, Manschot C, Kuhn E, Laber E, Somers TJ, Syrjala KL, Applebaum AJ. Assessing the utility of the PC-PTSD-5 as a screening tool among a cancer survivor sample. Cancer. 2024 Dec 1;130(23):4118-4126. doi: 10.1002/cncr.35504. Epub 2024 Aug 14.'}], 'seeAlsoLinks': [{'url': 'https://sites.duke.edu/transplantsurvivorcoach/contact-us/', 'label': 'Study Website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to use a stepped-care approach in treating symptoms of posttraumatic stress disorder (PTSD). The information learned by doing this study may help us to develop some target treatments for PTSD symptoms in survivors of stem cell transplant.\n\nParticipants in this study will be randomized to a mobile app or usual care. An assessment will be made after 4 weeks and a determination made of adding more intensive treatment. Participants will be asked to complete a questionnaire 4 times over a period of 6 months, at the time your participation is complete.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Completion of autologous or allogeneic HCT 1-5 years previously\n* Partial or complete remission (NED), may be receiving chemoprevention\n* Absence of severe psychological impairment (eg hospitalization for suicidality)\n* Approved for contact by oncologist\n* Able and willing to participate in a one-hour baseline interview\n* No prior CBT for PTSD\n* Owns a smart device with internet and email access\n* Able to read and write English\n* Significant PTSD symptoms as indicated by at least one of the following two criteria: probable cancer-related PTSD on the PCL5 by using the symptom cluster criteria; subthreshold or partial PTSD symptoms as determined by endorsement of reexperiencing cluster and less than or equal to 1 other symptom cluster\n\nExclusion Criteria:\n\n* If the participant does not fulfill the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04058795', 'briefTitle': 'PTSD Mobile App for Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Using a SMART Design to Optimize PTSD Symptom Management Strategies Among Cancer Survivors', 'orgStudyIdInfo': {'id': 'Pro00103154'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cancer Distress Coach (CaDC)', 'description': 'Participants in this group will get the mHealth CaDC app, which will give them tools based on cognitive behavioral therapy principles to manage their stress.', 'interventionNames': ['Behavioral: Cancer Distress Coach (CaDC) App']}, {'type': 'EXPERIMENTAL', 'label': 'CaDC and mCoaching', 'description': 'Participants in this group will get both the CaDC app and weekly clinician support.', 'interventionNames': ['Behavioral: CaDC + mCoaching']}, {'type': 'EXPERIMENTAL', 'label': 'mCBT', 'description': 'Participants in this group will get 8-sessions with a therapist to receive cognitive behavioral therapy (CBT).', 'interventionNames': ['Behavioral: mCBT']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in this group can use mental health services commonly available to all cancer patients at their local medical facility but will not receive access to the CaDC app.'}], 'interventions': [{'name': 'Cancer Distress Coach (CaDC) App', 'type': 'BEHAVIORAL', 'description': 'an app that provides participants with tools to manage their stress in the moment they experience it.', 'armGroupLabels': ['Cancer Distress Coach (CaDC)']}, {'name': 'CaDC + mCoaching', 'type': 'BEHAVIORAL', 'description': 'The CaDC app plus weekly clinician support which provides support in navigating the app, encouraging adherence to the use of the CaDC, and providing guidance in choosing treatment strategies.', 'armGroupLabels': ['CaDC and mCoaching']}, {'name': 'mCBT', 'type': 'BEHAVIORAL', 'description': '8 mobile sessions with a therapist to receive cognitive behavioral therapy.', 'armGroupLabels': ['mCBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Sophia K Smith, PhD, MSW', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}