Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT03979794
Status:
TERMINATED
Last Update Posted:
2024-11-14
First Post:
2019-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Distress Screening and Intervention in Cancer Surgery
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'}, {'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial (intervention vs. standard care)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Insufficient funding for research personnel prevented adequate recruitment and retention of research participants.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-12', 'studyFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2019-06-06', 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Health Questionnaire-8', 'timeFrame': '4-weeks post-operation (+/-1 week)', 'description': 'PHQ-8 assesses depression symptoms; A total score (range: 0-24) will be used with higher scores representing more depressive symptoms.'}, {'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': '4-weeks post-operation (+/-1 week)', 'description': 'The GAD-7 measures anxiety symptoms; A total score (range: 0-21) will be used with higher scores representing more anxiety symptoms.'}], 'secondaryOutcomes': [{'measure': 'Medical Outcomes Study Short Form-36 (SF-36) Physical Health Component Scale (PCS)', 'timeFrame': '4-weeks post-operation (+/-1 week)', 'description': 'The SF-36 PCS assesses physical health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher physical health-related QOL.'}, {'measure': 'Medical Outcomes Study Short Form-36 (SF-36) Mental Health Component Scale (MCS)', 'timeFrame': '4-weeks post-operation (+/-1 week)', 'description': 'The SF-36 MCS assesses mental health-related quality of life (QOL) on a 0-100 scale (with a mean of 50 and standard deviation of 10 for general population). Higher scores represent higher mental health-related QOL.'}, {'measure': 'Number of Complications', 'timeFrame': '30 days post-operation', 'description': 'Occurrence of: perioperative mortality, cardiac complications, postoperative pneumonia, intubation for \\>48-hours postoperatively unplanned reintubation, venous thromboembolic events, renal dysfunction, or surgical-site infections'}, {'measure': 'Length of post-operative hospital stay', 'timeFrame': '30 days post-operation', 'description': 'Number of days inpatient hospital stay after operation'}, {'measure': 'Hospital Readmission', 'timeFrame': '30 days post-operation', 'description': 'Number of times readmitted to a hospital after operation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Stress']}, 'descriptionModule': {'briefSummary': 'The goal of this project is to examine initial effectiveness of a brief (2 preoperative, 2 postoperative session) cognitive behaviorally-based telephone intervention compared to standard care on postoperative outcomes for patients who are scheduled to undergo a cancer-related surgery in 12 or more days and screen positive for distress (4 or higher on 0-10 Distress Thermometer). The intervention focuses on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care. Participants will be randomly assigned to receive the intervention or to receive standard care. Outcomes assessed 4 and 6 weeks post-operatively will include: Depression (Patient Health Questionnaire-8), anxiety (Generalized Anxiety Disorder-7), health-related QOL (SF-36 MCS and PCS), number and type of complications, length of stay, and 30-day readmission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ADULT (18 years of age or older)\n* SCHEDULED FOR SURGERY FOR CANCER (excluding non-melanoma skin cancer) 12 OR MORE DAYS IN ADVANCE OF CONSENT\n* SIGNIFICANTLY DISTRESSED (\\>4 on the 0-10 Distress Thermometer)\n* ABLE TO SPEAK ENGLISH\n\nExclusion Criteria:\n\n* COGNITIVE IMPAIRMENT : \\<4 on baseline Mini Cog measure\n* SERIOUS MENTAL ILLNESS: a diagnosis of a bipolar or psychotic disorder (noted in medical record)\n* NON-ENGLISH SPEAKING: This study only involves participants who can speak English.'}, 'identificationModule': {'nctId': 'NCT03979794', 'briefTitle': 'A Distress Screening and Intervention in Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'A Distress Screening and Intervention in Cancer Surgery', 'orgStudyIdInfo': {'id': 'H-40276'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Be-WEL Intervention', 'description': 'Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.', 'interventionNames': ['Behavioral: Behavioral Intervention for Wellness and Engaged Living (Be-WEL)']}, {'type': 'NO_INTERVENTION', 'label': 'Standard Care', 'description': 'Standard Care consists of the standard care patients typically receive from their medical team.'}], 'interventions': [{'name': 'Behavioral Intervention for Wellness and Engaged Living (Be-WEL)', 'type': 'BEHAVIORAL', 'description': 'Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.', 'armGroupLabels': ['Be-WEL Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Chelsea G Ratcliff, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baylor College of Medicine/Sam Houston State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not currently a plan to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Adjunct Assistant Professor', 'investigatorFullName': 'Chelsea Ratcliff', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}