Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-19 @ 7:20 PM
Study NCT ID:
NCT07176559
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2025-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2025-08-29', 'studyFirstSubmitQcDate': '2025-09-09', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of feasibility of the Spiritual Care Assessment and Intervention (SCAI) framework vs the attention control group', 'timeFrame': 'Weekly visits 1-4, within 3 months of enrollment', 'description': 'Percentage of participants completing interviews'}, {'measure': 'Evaluation of acceptability of the Spiritual Care Assessment and Intervention (SCAI) framework vs the attention control group', 'timeFrame': 'Weekly visits 1-4, within 3 months of enrollment', 'description': 'Acceptability Intervention Measure and Treatment Acceptability and Adherence Scales'}, {'measure': 'Test the effects of spiritual care on the outcome of spiritual wellbeing', 'timeFrame': 'Baseline, 1, 6, and 12 weeks post intervention', 'description': 'Measured by the Functional Assessment of Chronic Illness Therapy - Spirituality'}], 'secondaryOutcomes': [{'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on anxiety with spiritual care', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Generalize Anxiety Disorder - 7'}, {'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on depression with spiritual care', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Patient Health Questionnaire-8'}, {'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on satisfaction with spiritual care', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Patient Satisfaction Instrument-Chaplaincy and Client Satisfaction Questionnaire'}, {'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on spirituality', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Patient-Reported Outcomes Measurement Information System 7'}, {'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on religious coping', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Brief Religious Coping Scale (RCOPE)'}, {'measure': 'Effects of Spiritual Care Assessment and Intervention (SCAI) framework on positive affect', 'timeFrame': '1, 6, and 12 weeks post intervention', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect Short Form'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lung cancer', 'gastrointestinal cancer', 'spiritual care', 'spiritual wellbeing', 'spirituality'], 'conditions': ['Stage IV Lung Cancer', 'Lung Cancer', 'Gastrointestinal Malignancy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to address the need for effective spiritual care support for patients with lung and gastrointestinal cancer. This study will examine how spiritual care affects spiritual wellbeing, anxiety, depression, satisfaction with spiritual care, and quality of communication.', 'detailedDescription': 'This study is an individually randomized trial of chaplain-led intervention utilizing the Spiritual Care Assessment and Intervention (SCAI) framework compared to attention control. The chaplain intervention will consist of 4 spiritual care visits with a board-certified or board-eligible chaplain once a week for approximately 4 weeks. The attention control group will consist of 4 study visits with a trained social worker once a week for approximately 4 weeks.\n\nParticipants will be randomized 1:1 to the chaplain or attention control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥ 18 years old at the time of informed consent\n2. Ability to provide informed consent and HIPAA authorization\n3. Subject is at least 2 weeks post-diagnosis of an incurable and advanced stage (IV) lung or gastrointestinal (GI) malignancy and receiving cancer care at IU Simon Cancer Center, other IU Health Oncology Clinics, or Eskenazi Health Oncology Clinics\n4. Subject has a reliable phone and is willing to participate in 4 sessions with the chaplain\n5. ECOG score ranging from 0 (fully active) to 3 (able to conduct limited self-care in bed or chair more than 50% of waking hours)\n6. Has low Spiritual Well-Being score of 35 or less on the FACIT-Sp\n7. Subject makes 2 or fewer errors on the Callahan 6-item cognitive screener administered during screening\n\nExclusion Criteria:\n\n1. Subject makes 3 or more errors on the Callahan 6-item cognitive screener administered during screening, or exhibits significant psychiatric or cognitive impairment (e.g., dementia/delirium, intellectual disability, active psychosis) that in the judgment of the research team would preclude providing informed consent and study participation\n2. Currently receiving hospice care Note: subjects who enroll in hospice during the trial will have the option of continuing trial participation\n3. Have had a visit with a healthcare chaplain within the past 3 months'}, 'identificationModule': {'nctId': 'NCT07176559', 'acronym': 'PRaCTIS', 'briefTitle': 'Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Pilot Randomized Clinical Trial of Informational Support Versus Spiritual Care', 'orgStudyIdInfo': {'id': 'IUSCCC-0936'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chaplain Intervention Group', 'description': 'Eligible and consented participants that are randomized to the Chaplain Intervention Group will receive a total of 4 visits with a board-certified or board-eligible chaplain. These visits will occur weekly for approximately 4 weeks either in person, by telephone, or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.', 'interventionNames': ['Behavioral: Chaplain Intervention Group']}, {'type': 'NO_INTERVENTION', 'label': 'Attention Control Group', 'description': 'Eligible and consented patients randomized to the Attention Control group will receive 4 visits with a trained social worker. The visits will be conducted weekly for approximately 4 weeks. Each visit will take place for approximately 30 minutes.'}], 'interventions': [{'name': 'Chaplain Intervention Group', 'type': 'BEHAVIORAL', 'description': 'Eligible and consented participants that are randomized to the Chaplain Intervention Group will receive a total of 4 visits with a board-certified or board-eligible chaplain. These visits will occur weekly for approximately 4 weeks either in person, by telephone, or through a HIPAA compliant video platform. The visits will last an average of 30 minutes each.', 'armGroupLabels': ['Chaplain Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelley E Varner-Perez, MPH, MDiv, CPH, BCC', 'role': 'CONTACT', 'email': 'svarnerp@iu.edu', 'phone': '317-874-6984'}, {'name': 'Alexia M Torke, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Indiana University Melvin & Bren Simon Comprehensive Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shelley E Varner-Perez, MPH, MDiv, CPH, BCC', 'role': 'CONTACT', 'email': 'svarnerp@iu.edu', 'phone': '317-874-6984'}, {'name': 'Alexia M Torke, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sidney and Lois Eskenazi Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'centralContacts': [{'name': 'Shelley E Varner-Perez, MPH, MDiv, CPH, BCC', 'role': 'CONTACT', 'email': 'svarnerp@iu.edu', 'phone': '317-874-6984'}], 'overallOfficials': [{'name': 'Alexia M Torke, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Walther Cancer Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine and Section Chief, Palliative Medicine', 'investigatorFullName': 'Alexia M. Torke', 'investigatorAffiliation': 'Indiana University'}}}}