Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:29 AM
Study NCT ID:
NCT06927102
Status:
RECRUITING
Last Update Posted:
2025-09-19
First Post:
2025-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-16', 'studyFirstSubmitDate': '2025-04-07', 'studyFirstSubmitQcDate': '2025-04-13', 'lastUpdatePostDateStruct': {'date': '2025-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in follow-up data with proactive outreach', 'timeFrame': '6 months', 'description': 'Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about recurrence of disease, and these responses will be documented as valid follow-up entries.'}, {'measure': 'Updated mortality data', 'timeFrame': '6 months', 'description': 'For patients identified as lost-to-follow-up, proactive outreach efforts will be undertaken via phone calls, messages, or emails. Patients (or their families) will be queried about mortality (if applicable) and these responses will be documented as valid follow-up entries.'}], 'secondaryOutcomes': [{'measure': '3. Evaluate the reasons for patient disengagement from follow-up care.', 'timeFrame': '6 months', 'description': 'During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be documented as qualitative entries.'}, {'measure': 'Assessment of willingness for future hospital contact', 'timeFrame': '6 months', 'description': 'Participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Follow up', 'survivorship'], 'conditions': ['Breast Carcinoma']}, 'referencesModule': {'references': [{'pmid': '41334423', 'type': 'DERIVED', 'citation': 'Hariharan N, Rao TS, Rajappa SJ, Naidu CK, Rayani B, Kodandapani S, Koppula V, Gudipudi D. From exclusion to inclusion: Analysis of patterns of follow-up in breast cancer. Int J Surg Protoc. 2025 Sep 8;29(4):156-160. doi: 10.1097/SP9.0000000000000061. eCollection 2025 Dec.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to determine the proportion of patients who are lost-to-follow-up at five years, identify factors associated with loss of follow-up , and explore patient-reported barriers to follow-up in a public sector cancer care setting.\n\nThe main question it aims to answer is : Do proactive outreach programs help in improving follow-up rates among breast cancer patients who are categorized as "lost-to-follow-up." This study will be conducted in a real-world cohort of women with non-metastatic breast cancer treated at a tertiary care centre, between 2017-2018.', 'detailedDescription': 'This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute. Baseline data collection will include essential demographic information, clinical data including tumor characteristics, stage at presentation and luminal subtype and treatment information including surgical intervention, chemotherapy, radiotherapy, hormonal therapy, and targeted therapy.\n\nThe study will be conducted in three phases.\n\n1. Phase I: Quantitative Follow-Up Analysis Follow-up data will be retrieved from hospital records and electronic medical records (EMR) up to December 2024. Follow-up visits will be documented annually through to the end of 2024.\n2. Phase II: Assessment of Lost to Follow-Up (LTFU) Cases For patients identified as LTFU (definitions provided below), additional variables will be extracted, including geographic distance from the hospital, mode of employment, marital status, and payment method (government scheme, insurance, or self-pay). Proactive outreach efforts will be undertaken via phone calls, messages, or emails using contact information available in hospital records. Informed consent will be obtained in cases where contact has been successfully established - verbally for phone calls and in writing for electronic communication. Patients (or their families) will be queried about current health status, recent diagnostic evaluations, recurrence of disease, or mortality (if applicable). These responses will be documented as valid follow-up entries.\n3. Phase III: Qualitative Analysis of LTFU Reasons During outreach, participants will also be asked to identify reasons for missing follow-up visits. These will be categorized under the following domains: Logistical barriers (e.g., travel, time constraints), financial constraints, availability of alternative/local healthcare facilities, physician recommendations, lack of awareness regarding the importance of follow-up. In addition, participants will be asked about their willingness to maintain hospital contact in the future and their preferred mode of communication (e.g., phone, SMS, email, video call).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This is a prospective cohort study involving women diagnosed with non-metastatic breast cancer in the years 2017-2018, who received treatment at our institute, Basavatarakam Indo American Cancer Hospital \\& Research Institute, Hyderabad, India.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients newly diagnosed with non-metastatic breast cancer between 2017-2018\n2. Patients categorized as "lost-to-follow-up", as defined above\n3. Patients willing to participate upon re-engagement\n\nExclusion Criteria:\n\n1. Patients with incomplete medical records\n2. Patients who have taken part of the treatment at another hospital/centre\n3. Patients who have relocated permanently out of the study region\n\nWithdrawal Criteria:\n\n1\\. Patient withdraws consent'}, 'identificationModule': {'nctId': 'NCT06927102', 'acronym': 'FOCUS-BC', 'briefTitle': 'From Exclusion to Inclusion: Analysing Follow-up Discontinuity in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Basavatarakam Indo American Cancer Hospital & Research Institute'}, 'officialTitle': 'A Comprehensive Analysis of Follow-up Outcomes, Continuity and Updated Survivorship in Breast Cancer', 'orgStudyIdInfo': {'id': 'IEC/2024/295'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'New, non-metastatic, breast cancer patients between 2017-2018', 'description': 'All women with newly diagnosed non-metastatic breast cancer, presenting to Basavatarakam Indo American Cancer Hospital \\& Research Institute, Hyderabad, India, between 2017 - 2018 will be included in the study. The analysis will focus on the women who have been lost-to-follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '500034', 'city': 'Hyderabad', 'state': 'Telangana', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Clinical Trial Manager, B. Pharm', 'role': 'CONTACT', 'email': 'research.oncology@basavatarakam.org', 'phone': '022-23551235'}], 'facility': 'Basavatarakam Indo American Cancer Hospital & Research Institute', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}], 'centralContacts': [{'name': 'Clinical Trial Co-ordinator, Pharm D', 'role': 'CONTACT', 'email': 'research.oncology@basavatarakam.org', 'phone': '040-23551235'}], 'overallOfficials': [{'name': 'Nisha Hariharan, MS,HBNI Fellow Breast Oncology', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Basavatarakam Indo American Cancer Hospital & Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Since this study involves contacting women who are lost-to-follow-up, the investigators are considering various options for sharing IPD, with appropriate consent from the participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basavatarakam Indo American Cancer Hospital & Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant, Breast Oncosurgeon', 'investigatorFullName': 'Nisha Hariharan', 'investigatorAffiliation': 'Basavatarakam Indo American Cancer Hospital & Research Institute'}}}}