Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2026-03-19 @ 5:09 PM
Study NCT ID:
NCT02752061
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2016-04-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 979}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-21', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-25', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cancer stage', 'timeFrame': '1 day visit'}, {'measure': 'Time from initial clinic visit with cancer symptom/sign to entry into oncology care', 'timeFrame': '1 day visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neoplasms', 'HIV', 'Healthcare Disparity']}, 'referencesModule': {'references': [{'pmid': '29896450', 'type': 'DERIVED', 'citation': 'Tapela NM, Peluso MJ, Kohler RE, Setlhako II, Botebele K, Gabegwe K, Nkele I, Narasimhamurthy M, Mmalane M, Grover S, Barak T, Shulman LN, Lockman S, Dryden-Peterson S. A Step Toward Timely Referral and Early Diagnosis of Cancer: Implementation and Impact on Knowledge of a Primary Care-Based Training Program in Botswana. Front Oncol. 2018 May 29;8:187. doi: 10.3389/fonc.2018.00187. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Diagnostic and treatment delays contribute substantially to disparities in cancer morbidity and mortality between low- and middle- income countries (LMICs) and high-income countries. Individuals present with advanced stage disease resulting in minimal chance for cure or long-term survival.\n\nThe Potlako project will implement and evaluate a multifaceted intervention to test the hypothesis that a package of enhanced coordination of care including an electronic messaging, transportation support, and training targeted at generalist clinicians at primary and secondary level facilities, can reduce time to diagnosis and stage at diagnosis for HIV-infected individuals with cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Citizen of Botswana\n* Suspected or diagnosed cancer\n\nExclusion Criteria:\n\n* Involuntary incarceration'}, 'identificationModule': {'nctId': 'NCT02752061', 'briefTitle': 'Potlako: A Programmatic Intervention to Improve Access to Timely Oncology Care', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'Potlako: A Programmatic Multi-facility Level Intervention to Improve Access to Timely Oncology Care in Botswana', 'orgStudyIdInfo': {'id': 'BHP078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Kweneng East District', 'description': 'Patient presenting with possible cancer symptoms/sign to a clinic or hospital in Kweneng East District during study period.', 'interventionNames': ['Other: Potlako intervention']}, {'type': 'NO_INTERVENTION', 'label': 'All other districts', 'description': 'Patient presenting with possible cancer symptoms/sign to a clinic or hospital in all other districts of Botswana (or Kweneng East prior to implementation of intervention).'}], 'interventions': [{'name': 'Potlako intervention', 'type': 'OTHER', 'description': 'Multicomponent intervention including:\n\n* provider training on early detection and diagnostic approaches to cancer\n* patient education on importance of obtaining timely cancer diagnosis\n* provision of a patient navigator to facilitate diagnosis and entry into care\n* provision of transportation support to vulnerable patients', 'armGroupLabels': ['Kweneng East District']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gaborone', 'country': 'Botswana', 'facility': 'Botswana Harvard AIDS Institute', 'geoPoint': {'lat': -24.65451, 'lon': 25.90859}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, {'name': 'Botswana Harvard AIDS Institute Partnership', 'class': 'OTHER'}, {'name': 'Botswana Ministry of Health', 'class': 'OTHER_GOV'}, {'name': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Research Affiliate', 'investigatorFullName': 'Scott Dryden-Peterson', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}