Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 2:10 PM
Study NCT ID:
NCT06805669
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2025-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-23', 'studyFirstSubmitQcDate': '2025-01-28', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the difference of Health Related Quality of Life (HRQoL) for sarcoma patients who receive early palliative care versus not', 'timeFrame': 'From enrollment/baseline to 12 weeks', 'description': 'HRQoL will be assessed using ESAS-r (Edmonton Symptom Assessment System - revised) and EORTC QLQ-C30 (European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C-30).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sarcoma', 'Palliative Care'], 'conditions': ['Sarcoma']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.\n\nParticipants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written and voluntary informed consent.\n* Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.\n* Age ≥ 18 years.\n* Have not received any previous systemic treatment with palliative intent for advanced sarcoma.\n* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.\n* Life expectancy \\> 6 months.\n* Willing/able to complete questionnaires.\n\nExclusion Criteria:\n\n* Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.\n* Patient in need of urgent home support services or symptom management through a palliative care team.\n* Patient is being actively followed by a palliative care physician.\n* Active psychiatric disorder or drug abuse.\n* Insufficient English literacy to complete questionnaires.'}, 'identificationModule': {'nctId': 'NCT06805669', 'acronym': 'SARQUALITY', 'briefTitle': 'This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)', 'organization': {'class': 'OTHER', 'fullName': 'Mount Sinai Hospital, Canada'}, 'officialTitle': 'Integrating Early Palliative Care in Advanced SARcoma Patients for Enhanced QUALITY of Life: the SARQUALITY Study', 'orgStudyIdInfo': {'id': 'SARC-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Referral to Palliative Care', 'interventionNames': ['Other: Early referral to palliative care']}, {'type': 'OTHER', 'label': 'Standard Treatment', 'interventionNames': ['Other: Standard Treatment']}], 'interventions': [{'name': 'Early referral to palliative care', 'type': 'OTHER', 'description': 'Participant will be referred to palliative care at start of systemic treatment', 'armGroupLabels': ['Early Referral to Palliative Care']}, {'name': 'Standard Treatment', 'type': 'OTHER', 'description': 'Participants will be referred to palliative care upon appearance of uncontrollable symptoms.', 'armGroupLabels': ['Standard Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 1X5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Clinical Trials Manager', 'role': 'CONTACT', 'email': 'Oncology.Research@sinaihealth.ca', 'phone': '4165868440'}, {'name': 'Albiruni R. Abdul Razak', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Clinical Trials Manager', 'role': 'CONTACT', 'email': 'Oncology.Research@sinaihealth.ca', 'phone': '416-586-8440'}], 'overallOfficials': [{'name': 'Albiruni R. Abdul Razak', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Only IPD used in the results publication will be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mount Sinai Hospital, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}