Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-01-05 @ 12:26 AM
Study NCT ID:
NCT06501261
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CALM Psychotherapy in Patients With Metastatic Cancer in Chile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-08', 'studyFirstSubmitDate': '2023-01-17', 'studyFirstSubmitQcDate': '2024-07-08', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depressive symptoms', 'timeFrame': '3 months', 'description': 'Patient Health Questionnaire 9- Higher score means higher depression'}, {'measure': 'depressive symptoms', 'timeFrame': '6 months', 'description': 'Patient Health Questionnaire 9- Higher score means higher depression'}, {'measure': 'Death anxiety', 'timeFrame': '3 months', 'description': 'Death and Dying Distress Scale- Higher score means higher depression'}, {'measure': 'Death anxiety', 'timeFrame': '6 months', 'description': 'Death and Dying Distress Scale- Higher score means higher depression'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['psychotherapy', 'palliative care'], 'conditions': ['Metastatic Cancer']}, 'descriptionModule': {'briefSummary': 'Patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. Chile lacks evidence on effective therapeutic interventions in this population. CALM is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at The Princess Margaret Cancer Center. It consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. The Global CALM program aims to expand CALM research around the world, a program to which FALP has subscribed. Objective: To evaluate the preliminary efficacy of CALM in a sample of patients with metastatic cancer in Chile.\n\nPhase 2 study of preliminary, pseudo-experimental efficacy, without a control group. The study will be carried out in Falp and Corporación Valientes.', 'detailedDescription': 'Patients with metastatic cancer experience multidimensional challenges that increase the risk of emotional distress, which must be addressed by the health team. Chile lacks evidence on effective therapeutic interventions in this population. CALM is a brief, individual (with the presence of a caregiver in one or more sessions) and evidence-based psychotherapy developed at The Princess Margaret Cancer Center. It consists of an intervention of 3 to 6 psychotherapy sessions over a period of 3 to 6 months. The Global CALM program aims to expand CALM research around the world, a program to which FALP has subscribed. Objective: To evaluate the preliminary efficacy of CALM in a sample of patients with metastatic cancer in Chile.\n\nPhase 2 study of preliminary, pseudo-experimental efficacy, without a control group. The study will be carried out in Falp and Corporación Valientes.\n\nSample size 34 participants. Sessions will be online, 45 to 50 minutes long. Sessions can be recorded for supervision and training purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* be ≥18 years of age;\n* be fluent in Spanish;\n* be able to give informed consent; and\n* have received a diagnosis of advanced or metastatic solid tumor cancer with a reduced life expectancy but greater than six months.\n\nExclusion Criteria:\n\n* significant verbal communication difficulties;\n* cognitive impairment indicated by the clinical team or in the patient's file.\n* Patients currently in psychotherapy.\n* Active suicidal ideation"}, 'identificationModule': {'nctId': 'NCT06501261', 'acronym': 'CALM-Ch', 'briefTitle': 'CALM Psychotherapy in Patients With Metastatic Cancer in Chile', 'organization': {'class': 'OTHER', 'fullName': 'Fundacion Arturo Lopez Perez'}, 'officialTitle': 'Preliminary Efficacy and Acceptability of CALM Psychotherapy in Chile', 'orgStudyIdInfo': {'id': 'FALP 001-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CALM arm', 'description': 'patients receiving CALM sessions', 'interventionNames': ['Behavioral: CALM psychotherapy']}], 'interventions': [{'name': 'CALM psychotherapy', 'type': 'BEHAVIORAL', 'description': 'psychotherapy sessions', 'armGroupLabels': ['CALM arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7500921', 'city': 'Providencia', 'state': 'Santiago Metropolitan', 'status': 'RECRUITING', 'country': 'Chile', 'contacts': [{'name': 'Christian Caglevic, md', 'role': 'CONTACT', 'email': 'christian.caglevic@falp.org', 'phone': '2 2420 5100'}, {'name': 'Loreto Fernandez-Gonzalez, PhD(c)', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fundacion Arturo Lopez Perez', 'geoPoint': {'lat': -33.43107, 'lon': -70.60454}}], 'overallOfficials': [{'name': 'Loreto Fernandez-Gonzalez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fundacion Arturo Lopez Perez'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Session recordings will become available during scheduled supervision meetings and will only be watched once.', 'ipdSharing': 'YES', 'description': 'Supervision Meetings. CALM therapists (IP, co-IP) and the co-investigator team will attend in-person or online supervision meetings offered periodically by GIPPEC and the local research team. To ensure the quality of therapy, compliance with the CALM treatment manual, and delivery of best practices (especially in a diseased population), it is vital that therapists submit audio or video recorded session excerpts. Since CALM developers are located in Toronto, Canada, case discussions and audio or video presentation will be done through online platforms (Teams or Google Meet). These online platforms use secure protocols and are already in use at GIPPEC with other Global CALM participating centers. The videos will not be stored on online platforms. The identification data of the participating patients will not be disseminated in this instance, using only the study ID.', 'accessCriteria': 'GIPPEC faculty and team members'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fundacion Arturo Lopez Perez', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}