Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-04-01 @ 12:22 AM
Study NCT ID:
NCT02333604
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2015-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cancer Experience Registry (CER) for Cancer Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'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': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-12', 'size': 122777, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_004.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-04-12T14:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15000}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2035-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-12', 'studyFirstSubmitDate': '2015-01-06', 'studyFirstSubmitQcDate': '2015-01-06', 'lastUpdatePostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2035-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported quality of life measures', 'timeFrame': '7 days', 'description': 'Participant self-reported symptoms and functioning will be measured using the Patient-Reported Outcomes Measurement Information System-Preference Score (PROMIS-Pr). Five domains assess symptoms with higher scores corresponding to worse symptomology (Depression; Anxiety; Pain Interference; Fatigue; Sleep Disturbance) and three assess function with lower scores corresponding to worse functioning (Physical Function; Ability to Participate in Social Roles and Activities; Cognitive Function). Participants rate each item with reference to the past seven days; function scales have no timeframe specified. Scale scores are converted to standardized T scores (mean = 50, SD = 10); normative reference groups are the U.S. general population, except Sleep Disturbance, where comparisons are to a mix of the U.S. population and people with chronic illness.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cancer', 'cancer survivorship', 'psychosocial needs', 'cancer experience', 'acute myelogenous leukemia', 'breast cancer', 'breast cancer, metastatic', 'chronic lymphocytic leukemia', 'chronic myeloid leukemia', 'liver cancer', 'lung cancer', 'melanoma', 'multiple myeloma', 'myelodysplastic syndrome', 'ovarian cancer', 'prostate cancer', 'stomach cancer', 'bladder cancer', 'colorectal cancer', 'patient insights'], 'conditions': ['Neoplasms', 'Cancer', 'Caregiver']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cancersupportcommunity.org/sites/default/files/file/2020-07/CSC_Registry_Report_June_2020.pdf', 'label': 'The 2020 Registry Report highlights findings from the Cancer Experience Registry data'}]}, 'descriptionModule': {'briefSummary': 'The Cancer Experience Registry®: An Online Survey Research Study to Understand the Experiences of Those Impacted By a Cancer Diagnosis. The Registry is a web-based platform to distribute cross-sectional and longitudinal surveys. Study surveys are designed based on input from advisor experts, including patients and caregivers, and focus on the social, emotional, physical, financial and decision-making experiences of those who have been diagnosed with cancer and their caregivers. Findings contribute toward enhancing care for patients, survivors and caregivers via programming and policy initiatives.', 'detailedDescription': 'The aims of the Registry are to: 1) better understand the psychosocial experiences and needs of people who have been impacted by cancer, including patients, survivors and caregivers; 2) inform the research community, healthcare providers, patient advocates and policy makers around gaps in care and the psychosocial challenges of people affected by cancer; 3) use the findings to develop and disseminate tailored (data-guided) programs and services that will address the emotional and social needs and ultimately improve the long-term quality of life of people affected by cancer; 4) link registrants to cancer related resources and programs via an online, modifiable platform; and 5) provide collaborating sites (e.g., hospitals/health networks/CSC affiliates) with aggregated reports on quality and needs of members or customers to enhance or improve quality of care.\n\nFindings from the Registry are disseminated online at https://www.cancersupportcommunity.org/sites/default/files/file/2020-07/CSC\\_Registry\\_Report\\_June\\_2020.pdf'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any individual who has received a cancer diagnosis or has been a family caregiver or informal caregiver for someone diagnosed with cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Have received a cancer diagnosis or have been a family caregiver or informal caregiver (i.e., a relative or friend) for someone diagnosed with cancer\n* Live in United States, a US territory, or Canada\n* Able to read and understand English\n\nExclusion criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02333604', 'acronym': 'CER', 'briefTitle': 'Cancer Experience Registry (CER) for Cancer Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'Cancer Support Community, Research and Training Institute, Philadelphia'}, 'officialTitle': 'Cancer Experience Registry: An Online Survey Research Study to Understand the Experiences of Cancer Patients and Caregivers', 'orgStudyIdInfo': {'id': 'Salus IRB # 23044'}}, 'contactsLocationsModule': {'locations': [{'zip': '20015', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Erica E Fortune, PhD', 'role': 'CONTACT', 'email': 'efortune@cancersupportcommunity.org', 'phone': '202-659-9709'}, {'name': 'Claire Saxton, MBA', 'role': 'CONTACT', 'email': 'csaxton@cancersupportcommunity.org', 'phone': '202.659.9709'}], 'facility': 'Cancer Support Community Research & Training Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'centralContacts': [{'name': 'Erica E. Fortune, PhD', 'role': 'CONTACT', 'email': 'efortune@cancersupportcommunity.org', 'phone': '202.659.9709'}, {'name': 'Kara Doughtie, PhD', 'role': 'CONTACT', 'email': 'kdoughtie@cancersupportcommunity.org'}], 'overallOfficials': [{'name': 'Erica E. Fortune, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cancer Support Community'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD is not available at this time. Data in aggregate is shared with recruitment partners.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cancer Support Community, Research and Training Institute, Philadelphia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President, Research, Cancer Support Community', 'investigatorFullName': 'Erica E. Fortune', 'investigatorAffiliation': 'Cancer Support Community, Research and Training Institute, Philadelphia'}}}}