Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT05297734
Status:
RECRUITING
Last Update Posted:
2025-03-19
First Post:
2022-03-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003643', 'term': 'Death'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D012516', 'term': 'Osteosarcoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018213', 'term': 'Neoplasms, Bone Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cluster Randomized Controlled Trial among 26 clinics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2996}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-15', 'studyFirstSubmitDate': '2022-03-17', 'studyFirstSubmitQcDate': '2022-03-17', 'lastUpdatePostDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).', 'timeFrame': 'Change in health-related quality of life from baseline to 3 months', 'description': 'Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Change in health-related quality of life as assessed by the Functional Assessment of Cancer Therapy (FACT-G).', 'timeFrame': 'Change in health-related quality of life from baseline to 6, and 12 months', 'description': 'Each patient will receive a health-related quality of life survey (FACT-G) at baseline, 3 months, 6 months, and 12 months.'}, {'measure': 'Change in patient activation using the Patient Activation Measure (PAM-13).', 'timeFrame': 'Change in patient activation from baseline to 3, 6, and 12 months', 'description': 'Each patient will receive a validated patient activation survey (PAM-13) to assess their activation at baseline, 3 months, 6 months, and 12 months.'}, {'measure': 'Change in satisfaction with care using the Consumer Assessment of Health Care (Providers and Systems (CAHPS) Cancer Care Survey Questions #39 and #42.', 'timeFrame': 'Change in satisfaction with care from baseline to 3, 6, and 12 months', 'description': 'Each patient will receive a validated satisfaction with care survey at baseline, 3 months, 6 months, and 12 months.'}, {'measure': 'Change in satisfaction with decision using the Satisfaction with Decision Scale (SWD)', 'timeFrame': 'Change in satisfaction with decision from baseline to 3, 6, and 12 months', 'description': 'Each patient will receive a validated satisfaction with decision survey at baseline, 3 months, 6 months and 12 months.'}, {'measure': 'Palliative Care Use (Self-reported and Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Palliative care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6 and 12 months after patient enrollment.'}, {'measure': 'Hospice Care Use (Self-reported and Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Hospice care use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after patient enrollment.'}, {'measure': 'Emergency Department Visits (Self-reported and Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Emergency Department use will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.'}, {'measure': 'Hospitalization Visits (Self-reported and Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Hospital use for each patient will be self-reported by each patient or abstracted by electronic medical record at 3, 6, and 12 months after enrollment.'}, {'measure': 'Documentation of goals of care discussions (Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Documentation of goals of care discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.'}, {'measure': 'Documentation of symptom discussions (Chart Review)', 'timeFrame': '3, 6, and 12 months after patient enrollment', 'description': 'Documentation of symptom discussions will be abstracted by electronic medical record chart review for each patient at 3, 6, and 12 months after enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carcinoma', 'Lung Neoplasms', 'Carcinoma, Non-Small-Cell Lung', 'Melanoma', 'Pancreatic Neoplasms', 'Sarcoma', 'Ovarian Neoplasms', 'Carcinoma, Ovarian Epithelial', 'Stomach Neoplasms', 'Glioblastoma', 'Rectal Neoplasms', 'Colonic Neoplasms', 'Esophageal Neoplasms', 'Breast Neoplasms', 'Carcinoma, Renal Cell', 'Skin Neoplasms', 'Small Cell Lung Carcinoma', 'Osteosarcoma', 'Myelodysplastic Syndromes', 'Disease Progression', 'Neoplasms, Glandular and Epithelial', 'Neoplasms by Histologic Type', 'Neoplasms', 'Respiratory Tract Neoplasms', 'Thoracic Neoplasms', 'Neoplasms by Site', 'Lung Diseases', 'Respiratory Tract Diseases', 'Urogenital Neoplasms', 'Carcinoma, Bronchogenic'], 'conditions': ['End of Life', 'Cancer']}, 'descriptionModule': {'briefSummary': 'This cluster-randomized comparative effectiveness trial compares a technology-based supportive cancer care (SCC) approach with a redesigned team-based supportive cancer care (SCC) approach.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Greater intervention effects on health-related quality of life\n\nSECONDARY OBJECTIVES:\n\nI. Greater intervention effects on patient activation II. Greater satisfaction with care and decision-making III. Greater documentation of goals of care and symptoms IV. To lower acute care V. Greater palliative care and hospice\n\nOUTLINE: Sites are randomized to 1 of 2 arms.\n\nARM A: Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.\n\nARM B: Patients are paired with a lay health worker who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.\n\nAll participants complete a baseline interview upon enrollment during the initial consent phone contact and then a survey at 3-, 6-and 12-months post enrollment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed patients with solid tumor cancer diagnosis or recurrence of the disease.\n2. Patients must have the ability to understand and willingness to provide verbal consent.\n3. Participants must speak English, Spanish, Chinese, or Vietnamese.\n\nExclusion Criteria:\n\n1. Inability to consent to the study\n2. Plans to change oncologist within 12 months\n3. Employed by the practice site\n4. Patients who anticipate moving from the area within 12 months'}, 'identificationModule': {'nctId': 'NCT05297734', 'briefTitle': 'Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Comparative Effectiveness Trial of Two Supportive Cancer Care Delivery Models for Adults With Cancer', 'orgStudyIdInfo': {'id': '63646'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Technology-based supportive cancer care', 'description': 'Patients receive educational materials to assist with advance care planning and symptom management through a technology-based supportive cancer care weekly during months 1-4 and every other week during months 5-12.', 'interventionNames': ['Other: Receive technology-based supportive cancer care']}, {'type': 'EXPERIMENTAL', 'label': 'Redesigned team-based supportive cancer care', 'description': 'Patients are paired with a health educator who will discuss the same educational materials from ARM A either in person or by telephone discussions weekly during months 1-4 and every other week during months 5-12.', 'interventionNames': ['Behavioral: Receive redesigned team-based supportive cancer care']}], 'interventions': [{'name': 'Receive technology-based supportive cancer care', 'type': 'OTHER', 'otherNames': ['Technology-based SCC approach'], 'description': 'All participants will receive an electronic health record message or email with standardized information provided regarding advance care planning and symptom management.', 'armGroupLabels': ['Technology-based supportive cancer care']}, {'name': 'Receive redesigned team-based supportive cancer care', 'type': 'BEHAVIORAL', 'otherNames': ['Patients Activated in Cancer care through Teams (PACT), Redesigned SCC team-based approach'], 'description': 'Lay Health Workers will meet with 1:1 with participants over 12 months to discuss advance care planning, surrogate decision-makers, advance directives and physician orders for life sustaining treatment.', 'armGroupLabels': ['Redesigned team-based supportive cancer care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabrielle Rocque, MD', 'role': 'CONTACT'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36688', 'city': 'Mobile', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jennifer Y Pierce, MD', 'role': 'CONTACT'}], 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Finly Zachariah, MD', 'role': 'CONTACT', 'phone': '800-826-4673'}], 'facility': 'Beckman Research Institute of City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '93703', 'city': 'Fresno', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA Medical Center, Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '95128', 'city': 'Fruitdale', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sangeeta Aggarwal, MD', 'role': 'CONTACT'}], 'facility': 'Santa Clara Valley Medical Center', 'geoPoint': {'lat': 37.31086, 'lon': -121.93275}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Park, MD', 'role': 'CONTACT'}], 'facility': 'St Jude Heritage Medical Group', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richy Agajanian, MD', 'role': 'CONTACT'}], 'facility': 'Oncology Institute for Hope and Innovation', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95655', 'city': 'Mather', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Sacramento VA Medical Center - VA Northern California Health Care System', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}, {'zip': '93940', 'city': 'Monterey', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Pacific Cancer Care', 'geoPoint': {'lat': 36.60024, 'lon': -121.89468}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'VA Palo Alto', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Niharika Dixit, MD', 'role': 'CONTACT'}], 'facility': 'Zuckerberg San Francisco General', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Raymond Liu, MD', 'role': 'CONTACT'}], 'facility': 'Kaiser Foundation Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Rhoads, MD', 'role': 'CONTACT'}], 'facility': 'University of San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'San Francisco VA Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '96819', 'city': 'Honolulu', 'state': 'Hawaii', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Spark M. Matsunaga VA Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '89086', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'North Las Vegas VA Medical Center', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '84148', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'George E. Wahlen Department of Veterans Affairs Medical Center', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'centralContacts': [{'name': 'Manali I Patel, MD MPH MS', 'role': 'CONTACT', 'email': 'manalip@stanford.edu', 'phone': '6507234000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Manali Indravadan Patel', 'investigatorAffiliation': 'Stanford University'}}}}