Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 6:57 AM
Study NCT ID:
NCT00784095
Status:
COMPLETED
Last Update Posted:
2016-03-22
First Post:
2008-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outlook Quality of Life Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'karen.steinhauser@va.gov', 'phone': '9196682148', 'title': 'Dr. Karen Steinhauser', 'organization': 'VA Health Services Research and Development'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Therefore, due to the small sample size, finding are met with caution. Subjects were not randomized by any condition. As a result, those in the Control arm were more functionally able than the other two arms at baseline.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.\n\nAttention Control: Subjects listened to a non-guided relaxation CD.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'seriousEvents': [{'term': 'Death', 'notes': 'All patients in the trial were had advanced life-limiting illness. This was deemed not to be an unexpected event.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Life - Preparation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'OG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") will be exposed to no intervention or attention control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '14.4', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '16.0', 'spread': '3.7', 'groupId': 'OG001'}, {'value': '15.4', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': '6 week follow up', 'categories': [{'measurements': [{'value': '15.2', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '14.8', 'spread': '5.1', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '3.9', 'groupId': 'OG002'}]}]}, {'title': '8 week follow up', 'categories': [{'measurements': [{'value': '16.3', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '16.1', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '14.5', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '.047', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.9', 'ciLowerLimit': '.04', 'ciUpperLimit': '5.7', 'groupDescription': 'Intervention (Preparation and Completion) versus True Control at 8 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '4.7', 'groupDescription': 'Intervention (Preparation and Completion) versus Attention Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'OG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.3', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '21.0', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '29.7', 'spread': '6.4', 'groupId': 'OG002'}]}]}, {'title': '6 week follow up', 'categories': [{'measurements': [{'value': '23', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '24', 'spread': '8.1', 'groupId': 'OG001'}, {'value': '30.6', 'spread': '8.2', 'groupId': 'OG002'}]}]}, {'title': '8 week follow up', 'categories': [{'measurements': [{'value': '23.1', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '21.8', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '29.8', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '5.6', 'groupDescription': 'Intervention (Preparation and Completion) versus True Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-5.6', 'ciUpperLimit': '3.3', 'groupDescription': 'Intervention (Preparation and Completion) versus Attention Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 8 week follow ups', 'description': 'Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiology Studies - Depression Scale (CES-D)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'OG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.0', 'spread': '5.0', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '13.4', 'spread': '6.6', 'groupId': 'OG002'}]}]}, {'title': '6 week follow up', 'categories': [{'measurements': [{'value': '12.4', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '7.7', 'groupId': 'OG001'}, {'value': '12.3', 'spread': '6.8', 'groupId': 'OG002'}]}]}, {'title': '8 week follow up', 'categories': [{'measurements': [{'value': '9.4', 'spread': '4.2', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '12.1', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.6', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '2.9', 'groupDescription': 'Intervention (Preparation and Completion) versus True Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.6', 'ciLowerLimit': '-8.2', 'ciUpperLimit': '1.0', 'groupDescription': 'Intervention (Preparation and Completion) versus Attention Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'POMS Anxiety Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'OG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.0', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': '6 week follow up', 'categories': [{'measurements': [{'value': '5.1', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '4.0', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '4.4', 'groupId': 'OG002'}]}]}, {'title': '8 week follow up', 'categories': [{'measurements': [{'value': '4.6', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '4.8', 'spread': '5.4', 'groupId': 'OG001'}, {'value': '5.3', 'spread': '4.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.6', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '3.4', 'groupDescription': 'Intervention (Preparation and Completion) versus True Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '3.0', 'groupDescription': 'Intervention versus Attention Control at 8 weeks.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 8 week follow ups', 'description': 'The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'QUAL-E Completion Sub-scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'OG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'OG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '22.4', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '24.5', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '22.5', 'spread': '6.9', 'groupId': 'OG002'}]}]}, {'title': '6 week follow up', 'categories': [{'measurements': [{'value': '22.6', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '23.1', 'spread': '6.1', 'groupId': 'OG002'}]}]}, {'title': '8 week follow up', 'categories': [{'measurements': [{'value': '23.4', 'spread': '5.6', 'groupId': 'OG000'}, {'value': '24.1', 'spread': '5.9', 'groupId': 'OG001'}, {'value': '24.4', 'spread': '7.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.6', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '3.7', 'groupDescription': 'Intervention (Preparation and Completion) versus True Control at 8 weeks', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-1.9', 'ciUpperLimit': '6.7', 'groupDescription': 'Intervention (Preparation and Completion) versus Attention Control at 8 weeks.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'FG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'FG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") will be exposed to no intervention or attention control.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment")will meet with the facilitator three times for a period of forty-five minutes to one our. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.\n\nLife completion and preparation: Subjects will discuss life review, issues of forgiveness and heritage and legacy.'}, {'id': 'BG001', 'title': 'Attention Control', 'description': 'The subjects in the second group ("attention control") will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.\n\nAttention Control: Subjects will listen to a non-guided relaxation CD.'}, {'id': 'BG002', 'title': 'True Control', 'description': 'Subjects in the third group ("true control") will be exposed to no intervention or attention control.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': '10', 'groupId': 'BG000'}, {'value': '68', 'spread': '10', 'groupId': 'BG001'}, {'value': '69', 'spread': '14', 'groupId': 'BG002'}, {'value': '67', 'spread': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '35', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-11', 'studyFirstSubmitDate': '2008-10-30', 'resultsFirstSubmitDate': '2014-10-03', 'studyFirstSubmitQcDate': '2008-10-30', 'lastUpdatePostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-03-11', 'studyFirstPostDateStruct': {'date': '2008-11-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life - Preparation', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'Quality Of Life At The End Of Life (the QUAL-E 2009) is a 31 item measure of quality of life at the end of life assessing five domains: life completion, relationship with health care providers, preparation for death, physical symptoms and affective social support. The 4-item preparation sub-scale is a primary outcomes measure with each item scaled from 1 to 5 with a minimum of 5, maximum of 20 score with higher scores indicating better preparation.'}, {'measure': 'QUAL-E Completion Sub-scale', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'A sub-scale of the QUAL-E quality of life at the end of life measures. The scale range was 5-35 with higher scores indicating more positive sense of completion.'}], 'secondaryOutcomes': [{'measure': 'Functional Status ADL', 'timeFrame': 'Baseline, 6 and 8 week follow ups', 'description': 'Rosow-Breslau Activities of Daily Living scale range 17-51 with higher scores indicating greater ability.'}, {'measure': 'Center for Epidemiology Studies - Depression Scale (CES-D)', 'timeFrame': 'Baseline, 6 and 8 week follow up', 'description': 'Center for Epidemiology Studies - Depression Scale (CES-D) is a 10-item measure of depression. Items are rated on a 4 point likert scale with total scores ranging from 0-30. Higher scores indicate greater depressive symptoms.'}, {'measure': 'POMS Anxiety Sub-scale', 'timeFrame': 'Baseline, 6 and 8 week follow ups', 'description': 'The anxiety sub-scale from the modified Brief Profile of Mood States (POMS) is a 5-item measure of psychological distress.Items are on a 5-point likert scale with scoring ranging from 5-25. Higher scores indicate greater anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality of life'], 'conditions': ['Cancer', 'Congestive Heart Failure', 'Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '24803020', 'type': 'BACKGROUND', 'citation': 'Sautter JM, Tulsky JA, Johnson KS, Olsen MK, Burton-Chase AM, Lindquist JH, Zimmerman S, Steinhauser KE. Caregiver experience during advanced chronic illness and last year of life. J Am Geriatr Soc. 2014 Jun;62(6):1082-90. doi: 10.1111/jgs.12841. Epub 2014 May 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether discussions of life story, forgiveness, and future goals improve quality of life for patients with serious illness.', 'detailedDescription': 'This is a pilot randomized control trial to evaluate the feasibility of the Outlook intervention. 36 veterans with advanced cancer, congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) will be randomly assigned to one of three intervention groups and complete a brief battery of pre-test measures. Subjects in the first group ("treatment") will meet with a facilitator three times for a period of 45 min-1 hour. In the first session, subjects will be asked to discuss issues related to life review. In the second session, participants will be asked to speak in more depth about issues such as regret, forgiveness and things left undone, In the final session, subjects will focus on heritage and legacy. The subjects in the second group ("attention control") will meet with a facilitator three times for a period of 45 min- 1 hour and listen to a non-guided relaxation compact disk (CD). The third group of participants ("true control") will be exposed to no intervention or attention control. One week and two weeks later, participants in all groups will receive post-test measures administered by a blinded interviewer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with advanced cancer, CHF or COPD.\n\nExclusion Criteria:\n\nCognitive impairment, inability to speak, non-English speaking'}, 'identificationModule': {'nctId': 'NCT00784095', 'briefTitle': 'Outlook Quality of Life Intervention', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': 'Outlook: An Intervention to Improve Quality of Life in Serious Illness', 'orgStudyIdInfo': {'id': 'IAD 07-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Preparation and Completion', 'description': 'Subjects in the first group ("treatment") met with the facilitator three times for a period of forty-five minutes to one hour to discuss issues of life completion and preparation. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects discussed issues of heritage and legacy.', 'interventionNames': ['Other: Life completion and preparation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention Control', 'description': 'The subjects in the second group ("attention control") met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.', 'interventionNames': ['Other: Attention Control']}, {'type': 'NO_INTERVENTION', 'label': 'True Control', 'description': 'Subjects in the third group ("true control") were exposed to no intervention or attention control.'}], 'interventions': [{'name': 'Life completion and preparation', 'type': 'OTHER', 'description': 'Subjects will discuss life review, issues of forgiveness and heritage and legacy.', 'armGroupLabels': ['Preparation and Completion']}, {'name': 'Attention Control', 'type': 'OTHER', 'description': 'Subjects will listen to a non-guided relaxation CD.', 'armGroupLabels': ['Attention Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham VA Medical Center HSR&D COE', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Karen E. Steinhauser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Durham VA Medical Center HSR&D COE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}