Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT02603367
Status:
COMPLETED
Last Update Posted:
2017-08-15
First Post:
2015-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D000067250', 'term': 'Psychiatric Rehabilitation'}, {'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006282', 'term': 'Health Personnel'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-11', 'studyFirstSubmitDate': '2015-11-10', 'studyFirstSubmitQcDate': '2015-11-10', 'lastUpdatePostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Attrition rate', 'timeFrame': 'Up to 18 months', 'description': 'An electronic recruitment database will be created to document accrual, attrition, and retention rates.'}, {'measure': 'Change in caregiver psychological distress, measured using the Distress Thermometer', 'timeFrame': 'Baseline to 1 month post-intervention', 'description': 'Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. The established instruments will be scored according to standard instructions, and appropriate descriptive statistics will be computed. Outcomes will be compared pre- and post-intervention without full effectiveness analysis, as this is a pilot study.'}, {'measure': 'Recruitment rate', 'timeFrame': 'Up to 18 months', 'description': 'An electronic recruitment database will be created to document accrual, attrition, and retention rates.'}, {'measure': 'Retention rate', 'timeFrame': 'Up to 18 months', 'description': 'An electronic recruitment database will be created to document accrual, attrition, and retention rates.'}, {'measure': 'Themes derived from qualitative content analysis', 'timeFrame': 'Up to 18 months', 'description': 'Qualitative review of recruitment procedures and evaluation of research nurse feedback about intervention calls will be conducted. Content analysis will be conducted on the transcribed qualitative data. A qualitative summary of themes derived from study documents will be used. The intervention will be refined based on study results, and improvements made for it to be suited to a larger randomized, controlled trial.'}], 'secondaryOutcomes': [{'measure': 'Change in caregiver communication confidence, measured using the Caregiver Communication Survey', 'timeFrame': 'Baseline to 1 month post-intervention', 'description': 'Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. The established instruments will be scored according to standard instructions, and appropriate descriptive statistics will be computed. Outcomes will be compared pre- and post-intervention without full effectiveness analysis, as this is a pilot study.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Caregiver']}, 'descriptionModule': {'briefSummary': "This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver intervention in improving communication and reducing distress in caregivers of patients with lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to difficulty communicating with family, friends, and healthcare providers, or feeling unable to communicate openly. A communication intervention that improves the caregiver's ability to communicate with patients and healthcare providers may help reduce caregivers' psychological distress and improve the health outcomes of patients.", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess the feasibility of the COMFORT Caregiver Intervention (CCI) for family caregivers.\n\nII. To explore common family caregiver communication concerns in oncology and their impact.\n\nIII. Estimate the effects of the CCI on family caregivers\' psychological distress (primary outcome) and caregiver confidence with communication (secondary outcome).\n\nOUTLINE:\n\nParticipants receive the printed communication tool "A Communication Guide for Caregivers," a guide developed from the COMFORT communication curriculum, a national training program for palliative care communication. After a 1 week period to review the material, participants undergo communication coaching with a research nurse by phone over approximately 1 hour.\n\nAfter completion of the study, caregivers are followed up at 1 month to complete questionnaires and rate their satisfaction with the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Family caregivers will need to be the primary family caregiver as identified by the lung cancer patient (ten caregivers from each of the following cancer care continuum points will be recruited)\n* English-speaking\n* Cancer care continuum points are defined as follows:\n\n * Diagnosis: A lung cancer patient who has received diagnosis within the last 45 days but has not yet started treatment\n * Treatment: A lung cancer patients who has started initial treatment (chemotherapy, radiation, surgery) for diagnosis within the last 30 days, is actively receiving treatment, and has a prognosis of more than one year\n * Survivorship: A lung cancer patient who has completed treatment and who is clinically disease free at the time of caregiver enrollment to study\n * End of Life: A lung cancer patient who is estimated to have 6 months or less to live\n* All subjects must have the ability to understand and the willingness to participate in the informed consent process\n\nExclusion Criteria:\n\n* Research participants who do not speak or read English\n* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study'}, 'identificationModule': {'nctId': 'NCT02603367', 'acronym': 'COMFORT', 'briefTitle': 'COMFORT Caregiver Intervention in Improving Communication and Reducing Distress in Caregivers of Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'The COMFORT Caregiver Intervention (CCI)', 'orgStudyIdInfo': {'id': '15359'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01858', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '15359', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Supportive care (COMFORT communication intervention)', 'description': 'Participants receive the printed communication tool "A Communication Guide for Caregivers," a guide developed from the COMFORT communication curriculum, a national training program for palliative care communication. After a 1 week period to review the material, participants undergo communication coaching with a research nurse by phone over approximately 1 hour.', 'interventionNames': ['Other: Communication Intervention', 'Other: Educational Intervention', 'Other: Psychosocial Support for Caregiver', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Communication Intervention', 'type': 'OTHER', 'description': 'Undergo communication coaching', 'armGroupLabels': ['Supportive care (COMFORT communication intervention)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention, Educational'], 'description': 'Receive COMFORT communication curriculum', 'armGroupLabels': ['Supportive care (COMFORT communication intervention)']}, {'name': 'Psychosocial Support for Caregiver', 'type': 'OTHER', 'description': 'Undergo communication coaching', 'armGroupLabels': ['Supportive care (COMFORT communication intervention)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Complete questionnaires', 'armGroupLabels': ['Supportive care (COMFORT communication intervention)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Elaine Wittenberg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}