Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT03413332
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2018-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Web-Based Communication Education for Breast Cancer Survivorship Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-01-30', 'size': 447532, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-01-11T10:15', 'hasProtocol': True}, {'date': '2017-01-30', 'size': 370028, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-01-11T10:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 141}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-01', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-26', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Communication Competence Scale', 'timeFrame': '6 months', 'description': '16 items to assess information provision, seeking, and verifying; α=.80-.89.'}, {'measure': 'Assessment of Patient Experiences of Cancer Care', 'timeFrame': '6 months', 'description': '10-item patient-reported communication quality with follow-up care doctors; α=.75 in Chinese'}, {'measure': 'Decision-making Participation Self-efficacy Scale', 'timeFrame': '6 months', 'description': "5-item measure of patient's efficacy in engaging in medical communication; α=.89 in Chinese"}, {'measure': 'Perceived Personal Control Scale', 'timeFrame': '6 months', 'description': "4-item measure of patients' perceived personal control over breast cancer; α=.71 in Chinese"}], 'secondaryOutcomes': [{'measure': 'PROMIS Fatigue', 'timeFrame': '6 months', 'description': '6 items (e.g., felt tired, exhausted, limited at work); α=.97'}, {'measure': 'PROMIS Sleep Disturbance', 'timeFrame': '6 months', 'description': '6 items (e.g., sleep not steady, unsatisfied, hard to fall asleep); α=.98'}, {'measure': 'PROMIS Pain Interference', 'timeFrame': '6 months', 'description': '6 items (e.g., affecting ability to focus, interact with others, run errands); α=.95'}, {'measure': 'PROMIS Cognitive Function', 'timeFrame': '6 months', 'description': '6 items (e.g., had trouble concentrating, slow thinking, hard to concentrate); α=.95'}, {'measure': 'PROMIS Physical Function', 'timeFrame': '6 months', 'description': '8 items (e.g., carry heavy objects, kneeling, doing 2-hour labor work); α=.90'}, {'measure': 'PROMIS Anxiety', 'timeFrame': '6 months', 'description': '7 items (e.g., felt anxious, nervous, fearful, tense); α=.90'}, {'measure': 'PROMIS Depression', 'timeFrame': '6 months', 'description': '8 items (e.g., felt helpless, depressed, unhappy, hopeless); α=.90'}, {'measure': 'Side/late Effect Assessments', 'timeFrame': '6 months', 'description': '31-item measure of patient-reported side/late effects from breast cancer treatment'}, {'measure': 'Adherence to Breast Care Guidelines', 'timeFrame': '6 months', 'description': '26 yes-no items: receiving breast cancer follow-up care recommendations from doctors'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chinese American Women', 'Provider-patient Communication', 'Survivorship Care'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This two-phase research plan will develop and test a culturally relevant, web-based patient education program, hereafter known as E-Talkcare. The intervention aims to empower Chinese cancer patients to effectively communicate with different providers in different healthcare settings.', 'detailedDescription': "This two-phase study develops and tests the usability and efficacy of a culturally relevant, web-based patient education program, hereafter known as E-Talkcare, in improving Chinese immigrant breast cancer survivors' competence, perceived control, and self-efficacy in cancer care communication (intermediate outcomes), and patient-reported symptoms, adherence to breast cancer survivorship care guidelines, and quality of life (distal outcomes) versus the usual care control arm. In Phase I, community-based participatory research (CBPR) principles will be used to develop the intervention to educate participants about culture and communication by demonstrating how to ask for and verify information with doctors and use personalized symptom reports, and by providing question prompt lists for doctor visits. In Phase II, the intervention will be tested in a pilot randomized control trial (RCT). Using cases from Los Angeles Cancer Surveillance Program, California Cancer Registry, Maryland Cancer Registry, and clinics from California, 118 Chinese immigrant women (diagnosed with stage 0-III breast cancer and 1-3 years post-diagnosis) will be enrolled and randomized to either the E-Talkcare intervention or a usual care control arm. Participants will be interviewed via telephone at baseline (i.e., pre-randomization), 3-, and 6-months post-randomization."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nEligible Chinese women\n\n* ≥ age 18\n* foreign-born speaking Mandarin and/or Cantonese,\n* diagnosed with breast cancer at stage 0, I, II or III,\n* 1-3 years post-diagnosis and completed primary treatment (surgery, radiation, and chemotherapy); and\n* no recurrence, and 6) internet access.\n\nExclusion Criteria:\n\n* Women with other cancer types are ineligible due to different treatment complications.'}, 'identificationModule': {'nctId': 'NCT03413332', 'briefTitle': 'Web-Based Communication Education for Breast Cancer Survivorship Care', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Web-Based Communication Education for Breast Cancer Survivorship Care', 'orgStudyIdInfo': {'id': '2016-1407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-Talkcare Group', 'description': 'use the web-based patient education tool', 'interventionNames': ['Other: E-Talkcare']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care Group', 'description': 'receive usual care', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'E-Talkcare', 'type': 'OTHER', 'description': "Women in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered.", 'armGroupLabels': ['E-Talkcare Group']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Survivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants.', 'armGroupLabels': ['Usual Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Judy Wang, PhD', 'role': 'CONTACT', 'email': 'jw235@georgetown.edu', 'phone': '202-687-6306'}, {'name': 'Judy (Huei_Yu) Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Judy Wang, Ph.D.', 'role': 'CONTACT', 'email': 'jw235@georgetown.edu', 'phone': '202-687-6306'}, {'name': 'Jiayan Gu, MSPH', 'role': 'CONTACT', 'email': 'jg1829@georgetown.edu', 'phone': '202-687-8007'}], 'overallOfficials': [{'name': 'Judy Wang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Judy Wang', 'investigatorAffiliation': 'Georgetown University'}}}}