Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2026-03-06 @ 6:39 PM
Study NCT ID:
NCT03016403
Status:
COMPLETED
Last Update Posted:
2021-03-19
First Post:
2016-12-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Evelinn.Borrayo@cuanschutz.edu', 'phone': '303-724-0884', 'title': 'Evelinn Borrayo, Associate Director', 'organization': 'Latino Research and Policy Center, University of Colorado Denver'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Between baseline through the six month follow-up. Adverse events can be reported by the study coordinators at anytime from baseline through completion of the 6 month follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 0, 'seriousNumAtRisk': 139, 'deathsNumAffected': 13, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 0, 'seriousNumAtRisk': 147, 'deathsNumAffected': 18, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 0, 'seriousNumAtRisk': 118, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 0, 'seriousNumAtRisk': 131, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'notes': 'Head-and-neck/lung cancer or complications related to the diagnoses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure with hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptoms of Depression-Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.75', 'ciLowerLimit': '0.52', 'ciUpperLimit': '2.98', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population- all participants who were randomized were included in this analysis. The reported means correspond to the observed means at 6 months.'}, {'type': 'PRIMARY', 'title': 'Symptoms of Anxiety-Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.'}, {'id': 'OG001', 'title': 'Stepped-Care Intervention', 'description': 'Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.\n\nStepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.0', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '13.9', 'spread': '6.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0243', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.46', 'ciLowerLimit': '0.19', 'ciUpperLimit': '2.73', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'PRIMARY', 'title': 'Change in Coping-Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.'}, {'id': 'OG001', 'title': 'Stepped-Care Intervention', 'description': 'Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.\n\nStepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '190', 'spread': '55', 'groupId': 'OG000'}, {'value': '207', 'spread': '54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0061', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.31', 'ciLowerLimit': '-26.23', 'ciUpperLimit': '-4.39', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'Linear mixed models (LMM) have been used with time and the interaction between time and group as fixed effects. A structure of random effects that includes random intercepts for patients was used. The study was powered for testing the hypothesis of no group differences in change over the four time points. A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of an interaction between time and intervention arm.'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'SECONDARY', 'title': 'Change in Coping-Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enhanced Usual Care', 'description': 'Enhanced Usual Care: Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.'}, {'id': 'OG001', 'title': 'Stepped-Care Intervention', 'description': 'Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.\n\nStepped-Care Intervention: The intervention delivered evidence-based CBT and stress management across eight counseling sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '192', 'spread': '52', 'groupId': 'OG000'}, {'value': '211', 'spread': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.73', 'ciLowerLimit': '-19.73', 'ciUpperLimit': '4.27', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'SECONDARY', 'title': 'Symptoms of Anxiety-Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'spread': '7', 'groupId': 'OG000'}, {'value': '14', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.052', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '3.05', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptoms of Depression-Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15.0', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.214', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.91', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '2.36', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life-Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'spread': '19', 'groupId': 'OG000'}, {'value': '80', 'spread': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0134', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.16', 'ciLowerLimit': '-7.45', 'ciUpperLimit': '-0.87', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population.'}, {'type': 'SECONDARY', 'title': 'Perceived Stress-Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '7', 'groupId': 'OG000'}, {'value': '13', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.42', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.61', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '2.12', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'intention to treat population'}, {'type': 'SECONDARY', 'title': 'Perceived Stress-Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'spread': '7', 'groupId': 'OG000'}, {'value': '11', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0269', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '0.2', 'ciUpperLimit': '3.34', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caregiving Burden-Caregivers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care'}, {'id': 'OG001', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'spread': '9', 'groupId': 'OG000'}, {'value': '9', 'spread': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.56', 'ciLowerLimit': '0.8', 'ciUpperLimit': '4.32', 'pValueComment': 'Since there are three primary outcomes (depression, anxiety and coping scores) in the study, the significance level was set a priori at 0.0167 (alpha = 0.05/3).', 'estimateComment': 'The estimate represents the difference in expected means at the 6-month time point between the intervention and usual care arms.', 'groupDescription': 'A linear mixed model (LMM) with random intercepts for both patients and clinics has been used, with adjustment for cancer type and cancer stage. The study was powered for testing the hypothesis of no group differences in change over the four time points (baseline, 6-weeks, 3-months and 6-months). A significant group by time interaction was hypothesized.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The pvalue corresponds to the hypothesis of the interaction effect between time and group (intervention arm).'}], 'paramType': 'MEAN', 'timeFrame': '6-months', 'description': 'Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care'}, {'id': 'FG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention'}, {'id': 'FG002', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized into Enhanced Usual Care'}, {'id': 'FG003', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '139'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '34'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '24'}]}]}, {'title': '6-week Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Anyone who had at least 1 follow-up after baseline.', 'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '120'}, {'groupId': 'FG002', 'numSubjects': '107'}, {'groupId': 'FG003', 'numSubjects': '97'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': '3-month Follow-up and 6-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '107'}, {'groupId': 'FG002', 'numSubjects': '103'}, {'groupId': 'FG003', 'numSubjects': '88'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '96'}, {'groupId': 'FG002', 'numSubjects': '95'}, {'groupId': 'FG003', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Both patients and caregivers were recruited for this study. Primary outcomes data were focused on patients. Caregiver data were included as secondary analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients in Enhanced Usual Care', 'description': 'Patients who were randomized to Enhanced Usual Care'}, {'id': 'BG001', 'title': 'Patients in Stepped Care Intervention', 'description': 'Patients who were randomized to the Stepped Care Intervention'}, {'id': 'BG002', 'title': 'Caregivers in Enhanced Usual Care', 'description': 'Caregivers who were randomized to Enhanced Usual Care'}, {'id': 'BG003', 'title': 'Caregivers in Stepped Care Intervention', 'description': 'Caregivers who were randomized to the Stepped Care Intervention'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Under 18', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '18 to 65', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '267', 'groupId': 'BG004'}]}, {'title': 'Above 65', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Report', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}, {'value': '310', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '225', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}, {'value': '126', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}, {'value': '408', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '107', 'groupId': 'BG003'}, {'value': '451', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Language Preference', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'English', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '494', 'groupId': 'BG004'}]}, {'title': 'Spanish', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '41', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Head and neck cancer', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '120', 'groupId': 'BG004'}]}, {'title': 'Lung cancer', 'measurements': [{'value': '79', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '166', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Diagnosis data were not collected from caregivers.'}, {'title': 'Cancer Stage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '286', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Stage 0, I, & II', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '132', 'groupId': 'BG004'}]}, {'title': 'Stage III & IV', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '151', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Cancer Stage were clinically diagnosed by medical oncologists at each site and were self-reported by patients in the baseline survey. The cancer stages varied between stage 0, I, II, III, and IV with IV being the most advanced.', 'unitOfMeasure': 'Participants', 'populationDescription': 'No cancer stage was collected from the caregivers.'}, {'title': 'Step at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '535', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Step 1 & 2', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '415', 'groupId': 'BG004'}]}, {'title': 'Step 3 & 4', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}, {'value': '119', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The treatment steps that participants were assigned to, based on their personal level of distress included:\n\nStep 1: Watchful Waiting Step 2: Self-Help Guide Step 3: Coping Skills Training Step 4: Cognitive-Behavioral Therapy', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-11-30', 'size': 1096590, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-30T17:37', 'hasProtocol': True}, {'date': '2018-11-30', 'size': 137367, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-10-30T17:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 535}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-24', 'studyFirstSubmitDate': '2016-12-27', 'resultsFirstSubmitDate': '2020-11-02', 'studyFirstSubmitQcDate': '2017-01-06', 'lastUpdatePostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-24', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of Depression-Patients', 'timeFrame': '6-months', 'description': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.'}, {'measure': 'Symptoms of Anxiety-Patients', 'timeFrame': '6-months', 'description': 'Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.'}, {'measure': 'Change in Coping-Patients', 'timeFrame': '6-months', 'description': 'Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.'}], 'secondaryOutcomes': [{'measure': 'Change in Coping-Caregivers', 'timeFrame': '6-months', 'description': 'Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.'}, {'measure': 'Symptoms of Anxiety-Caregivers', 'timeFrame': '6-months', 'description': 'PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.'}, {'measure': 'Symptoms of Depression-Caregivers', 'timeFrame': '6-months', 'description': 'PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.\n\nThe number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively.'}, {'measure': 'Health-Related Quality of Life-Patients', 'timeFrame': '6-months', 'description': 'FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.'}, {'measure': 'Perceived Stress-Patients', 'timeFrame': '6-months', 'description': 'Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.'}, {'measure': 'Perceived Stress-Caregivers', 'timeFrame': '6-months', 'description': 'Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.'}, {'measure': 'Caregiving Burden-Caregivers', 'timeFrame': '6-months', 'description': 'Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer, Lung', 'Cancer, Head and Neck']}, 'referencesModule': {'references': [{'pmid': '37772984', 'type': 'DERIVED', 'citation': 'Borrayo EA, Juarez-Colunga E, Kilbourn K, Waxmonsky J, Jacobson M, Okuyama S, Swaney R, Wamboldt FS, Karam S, Lopez Alvarez S, Jin X, Nguyen J. Stepped-care to improve mental health outcomes among underserved patients with lung and head and neck cancer. Psychooncology. 2023 Nov;32(11):1718-1726. doi: 10.1002/pon.6223. Epub 2023 Sep 29.'}]}, 'descriptionModule': {'briefSummary': 'Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally encounter significant disparities in accessing care for their mental health needs while undergoing toxic treatments that provide considerable physical and emotional stress. Thus, the investigators propose to adapt evidence-based strategies to a stepped-care intervention model to address the mental health needs of under-served lung cancer (LC) and head and neck cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g., mild, moderate, or severe symptoms of depression and anxiety).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '1. LC and HNC patients:\n\n Inclusion Criteria:\n * Newly diagnosed LC and/or HNC (within a month of recruitment date from the date of 1st visit oncology, Ear Nose and Throat (ENT), or radiation clinic visit/consultation upon pathologic tissue diagnosis;\n * LC and/or HNC patients at any stage of diagnosis (Stages 0-IV);\n * Over 18 years old;\n * English and/or Spanish speaking;\n * Medically underserved, as defined by at least one or several of the following:\n\n 1. Low-income: Below 400% of the 2016 Federal poverty levels;\n 2. Uninsured: No health insurance (public or private insurance);\n 3. Underinsured: e.g.: Public insurance (Medicaid, Medicare exclusive, VA); and/or 10% of annual income on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty levels.\n\n Exclusion Criteria:\n * Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish;\n * Those who refuse treatment at one of three hospital sites;\n * Decisionally-challenged adults with cognitive or personality impairment;\n * Suicidal ideation, or\n * Intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study;\n * Individuals from vulnerable populations (e.g., inmates or individuals on probation,\n * homeless,\n * pregnant women, and\n * those with auditory impairment.\n\n Note: Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.\n2. Caregivers of LC and/or HNC patients\n\nInclusion Criteria:\n\n* Primary caregiver of a newly diagnosed LC and/or HNC patient (per criteria for patients);\n* Over 18 years old;\n* English and/or Spanish speaking;\n* Medically underserved, as defined by at least one or several of the following:\n\n 1. Low-income: Below 400% of the 2016 Federal poverty levels;\n 2. Uninsured: No health insurance (public or private insurance);\n 3. Underinsured:\n* (c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA);\n* (c.2) 10% of annual income spent on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty level.\n\nExclusion criteria:\n\n* Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \\[at the discretion of the Site Coordinators upon recruitment\\];\n* Caregivers of patients who refuse treatment at one of three hospital sites.\n* Decisionally challenged adults with:\n\n 1. cognitive or personality impairment,\n 2. suicidal ideation, or\n 3. intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study \\[at the discretion of the Site Coordinators upon recruitment or the Counselor during the intervention\\];\n* Individuals from:\n\n 1. vulnerable populations (e.g., inmates or individuals on probation, homeless,\n 2. pregnant women, and\n 3. those with auditory impairment \\[at the discretion of the Site Coordinators upon recruitment\\]).\n 4. Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.'}, 'identificationModule': {'nctId': 'NCT03016403', 'briefTitle': 'A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers', 'orgStudyIdInfo': {'id': '16-2621.cc'}, 'secondaryIdInfos': [{'id': 'AD-1511-33395', 'type': 'OTHER_GRANT', 'domain': 'PCORI'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stepped-Care Intervention', 'description': 'Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.', 'interventionNames': ['Behavioral: Stepped-Care Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': "Denver Health, St. Mary's and St. Joseph's hospitals provide supportive mental health care for patients such as printed materials, support groups, crisis counseling, and specialized care (e.g., psychiatric medication). Because the amount of usual mental health care that each patient receives varies at each site, the investigators will standardize and monitor the usual care arm across the three sites with an enhanced usual care condition.", 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'Stepped-Care Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention delivered evidence-based CBT and stress management across eight counseling sessions.', 'armGroupLabels': ['Stepped-Care Intervention']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'otherNames': ['Standard of Care'], 'description': 'Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Saint Joseph Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '81502', 'city': 'Grand Junction', 'state': 'Colorado', 'country': 'United States', 'facility': "Saint Mary's Hospital and Regional Medical Center", 'geoPoint': {'lat': 39.06387, 'lon': -108.55065}}], 'overallOfficials': [{'name': 'Evelinn A Borrayo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}