Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 4:59 PM
Study NCT ID:
NCT06180460
Status:
COMPLETED
Last Update Posted:
2025-10-08
First Post:
2023-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CALM: Managing Distress in Malignant Brain Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-02', 'studyFirstSubmitDate': '2023-12-12', 'studyFirstSubmitQcDate': '2023-12-12', 'lastUpdatePostDateStruct': {'date': '2025-10-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the feasibility of the CALM intervention- Screening Rate', 'timeFrame': 'Day 0', 'description': 'Percent of interested individuals who undergo screening'}, {'measure': 'Assess the feasibility of the CALM intervention- Consent Rate', 'timeFrame': 'Day 0', 'description': 'Percent of eligible individuals who consent to the trial'}, {'measure': 'Assess the feasibility of the CALM intervention- Intervention Retention Rate', 'timeFrame': '3 months', 'description': 'Percent of consented individuals who complete the CALM intervention'}, {'measure': 'Assess the feasibility of the CALM intervention- Post-Intervention Questionnaire Completion Rate', 'timeFrame': '3 months', 'description': 'Percent of consented individuals who complete post-intervention questionnaires'}, {'measure': 'Assess the feasibility of the CALM intervention- Follow-up Questionnaire Completion Rate', 'timeFrame': '6 months', 'description': 'Percent of consented individuals who complete follow-up questionnaires'}, {'measure': 'Assess the acceptability of the CALM intervention- Participant Satisfaction', 'timeFrame': '4 months', 'description': 'Satisfaction ratings from participants during exit interview (e.g., Rate your overall benefit on a scale of 1-5).'}, {'measure': 'Assess the acceptability of the CALM intervention- Participant Recommendation Ratings', 'timeFrame': '4 months', 'description': 'Percent of participants who would recommendation CALM to others will be assessed during the exit interview (e.g., Would you recommend this program to others?)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Service Members', 'Veterans'], 'conditions': ['Brain Tumor', 'Brain Metastases', 'Brain Cancer', 'Metastatic Lung Cancer', 'Metastatic Breast Cancer', 'Metastatic Melanoma', 'Metastatic Colon Cancer', 'Metastatic Kidney Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an empirically supported psychotherapeutic intervention, Managing Cancer and Living Meaningfully (CALM), compared to treatment as usual (TAU) in those with malignant brain cancer diagnoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-reported diagnosis of brain metastasis (bMET) or a malignant primary brain tumor (PBT; specifically grade III or IV and CNS diffuse large B cell lymphomas)\\*\n* At least 2-weeks post-surgical resection or biopsy of the brain (if applicable)\n* Score \\> 20 on the TICS\n* Reported elevated depression (PHQ-9 score ≥ 10) OR death anxiety symptoms (DADDS score ≥ 15)\n* Ability to read, speak, and understand English\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Major communication difficulties which would prohibit the psychotherapeutic interaction\n* Inability to meet with the interventionist via an electronic device for telehealth intervention sessions\n* Inability to understand and provide informed consent\n* Prisoners\n* Medical, psychological, or social condition that, in the opinion of the principal investigator, may increase the participant's risk of adverse events and/or prohibit the individual's participation in the intervention."}, 'identificationModule': {'nctId': 'NCT06180460', 'briefTitle': 'CALM: Managing Distress in Malignant Brain Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Managing Distress in Malignant Brain Cancer - Phase IIc RCT', 'orgStudyIdInfo': {'id': 'MCC-23-20816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Managing Cancer and Living Meaningfully (CALM)', 'description': 'CALM optimally consists of six individual sessions of 45 to 60 minutes, delivered over a three- to six-month period. CALM sessions address four broad and interrelated domains found to be important and relevant in this population: (1) symptom management and communication with healthcare providers, (2) changes in personal relationships, (3) sense of meaning and purpose, and (4) the future, hope and mortality.', 'interventionNames': ['Behavioral: CALM']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment as Usual (TAU)', 'description': 'Treatment as usual (TAU) for managing distress in brain cancer involves being provided a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.', 'interventionNames': ['Behavioral: Treatment as usual']}], 'interventions': [{'name': 'CALM', 'type': 'BEHAVIORAL', 'description': 'The CALM intervention is a supportive-expressive therapy that is administered by CALM trained clinicians in a particular style.', 'armGroupLabels': ['Managing Cancer and Living Meaningfully (CALM)']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual includes a list of local / national resources (e.g., psychologist, social worker, or other mental health providers) if an individual chooses to seek treatment for the distress they are experiencing.', 'armGroupLabels': ['Treatment as Usual (TAU)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Ashlee Loughan, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}