Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-06 @ 1:14 PM
Study NCT ID:
NCT02334332
Status:
WITHDRAWN
Last Update Posted:
2015-09-25
First Post:
2015-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-23', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-07', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient/informal caregiver satisfaction with timing, content, and delivery of the intervention', 'timeFrame': 'Up to 2 months', 'description': 'Descriptive statistics will be presented through summary statistics of data from the satisfaction tools.'}], 'secondaryOutcomes': [{'measure': 'Change in mean survey scores', 'timeFrame': 'Baseline up to 4 weeks', 'description': 'Data will be summarized using descriptive statistics. Statistics will be tabulated for each sequentially enrolled cohort.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Caregiver'], 'conditions': ['Anxiety', 'Gastric Carcinoma', 'Stress']}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies an educational brochure in preparing patients with gastric cancer and their caregivers for recovery after surgery. Giving an educational brochure may help prepare patients and their caregivers by improving knowledge about symptoms after surgery. It may also improve quality of life and reduce worry after surgery.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To pilot test an educational intervention in the form of a teaching brochure to prepare patients and informal caregivers for recovery following partial or total gastrectomy.\n\nSECONDARY OBJECTIVES:\n\nI. To describe preliminary effect of the intervention on patient-reported outcomes (PROs), informal caregiver-reported outcomes, and clinical/system outcomes.\n\nOUTLINE: Participants are enrolled sequentially to 1 of 2 cohorts.\n\nCOHORT I: Participants receive standard post-operative care.\n\nCOHORT II: Participants receive a 2-page educational brochure after surgery and prior to discharge home.\n\nAfter completion of study, participants are followed up for approximately 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be accrued using the following inclusion criteria:\n\n * Scheduled to undergo partial or total gastrectomy for treatment of gastric cancer\n * Able to read and understand English\n* Informal Caregivers will be accrued using the following inclusion criteria:\n\n * The primary informal caregiver as identified by patients participating in the study; this refers to either a family member or friend who will be providing the majority of care following surgery\n * Able to read and understand English\n* All participants must have the ability to understand the willingness to provide informed consent\n\nExclusion Criteria:\n\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study'}, 'identificationModule': {'nctId': 'NCT02334332', 'briefTitle': 'Educational Brochure in Preparing Patients With Gastric Cancer and Their Caregivers for Recovery After Surgery', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Pilot Study of an Educational Brochure to Prepare Patients and Informal Caregivers for Recovery Following Gastrectomy', 'orgStudyIdInfo': {'id': '14286'}, 'secondaryIdInfos': [{'id': 'NCI-2014-02563', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '14286', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort I (standard care)', 'description': 'Participants receive standard post-operative care.', 'interventionNames': ['Procedure: Standard Follow-Up Care', 'Procedure: Quality-of-Life Assessment']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort II (educational brochure)', 'description': 'Participants receive a 2-page educational brochure after surgery and prior to discharge home.', 'interventionNames': ['Other: Educational Intervention', 'Procedure: Quality-of-Life Assessment']}], 'interventions': [{'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention, Educational'], 'description': 'Receive educational brochure', 'armGroupLabels': ['Cohort II (educational brochure)']}, {'name': 'Standard Follow-Up Care', 'type': 'PROCEDURE', 'description': 'Receive standard post-operative care', 'armGroupLabels': ['Cohort I (standard care)']}, {'name': 'Quality-of-Life Assessment', 'type': 'PROCEDURE', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Cohort I (standard care)', 'Cohort II (educational brochure)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Virginia Sun', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}