Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04585269
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2020-10-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bright IDEAS - Young Adults Problem-Solving Skills Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'katie.devine@rutgers.edu', 'phone': '7322357549', 'title': 'Dr. Katie Devine (PI)', 'organization': 'Rutgers Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline and Randomization, through FU Time 3 (6 months). Adverse event data collection is still ongoing and will be updated upon study completion, and additional adverse event data can be added when they become available.', 'description': 'Study team was notified by Epic or medical record (automatically)', 'eventGroups': [{'id': 'EG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.', 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 0, 'seriousNumAtRisk': 171, 'deathsNumAffected': 6, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 0, 'seriousNumAtRisk': 173, 'deathsNumAffected': 3, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Death due to disease progression', 'notes': "Participants' death was due to their disease progression, which can be expected when working with patients with cancer. Death was unrelated to the study, which is evaluating a supportive care problem-solving intervention to reduce distress.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 173, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.92', 'groupId': 'OG000', 'lowerLimit': '-4.14', 'upperLimit': '-1.69'}, {'value': '0.31', 'groupId': 'OG001', 'lowerLimit': '-0.86', 'upperLimit': '1.49'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.23', 'ciLowerLimit': '-4.93', 'ciUpperLimit': '-1.53', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Testing for a difference between arms'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.', 'unitOfMeasure': 'T-score points', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)'}, {'type': 'PRIMARY', 'title': 'Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.21', 'groupId': 'OG000', 'lowerLimit': '-3.38', 'upperLimit': '-1.04'}, {'value': '0.22', 'groupId': 'OG001', 'lowerLimit': '-0.90', 'upperLimit': '1.34'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.43', 'ciLowerLimit': '-4.05', 'ciUpperLimit': '-0.81', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Testing for a difference between arms'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.', 'unitOfMeasure': 'T-score points', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)'}, {'type': 'PRIMARY', 'title': 'Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}, {'id': 'OG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.06', 'groupId': 'OG000', 'lowerLimit': '3.85', 'upperLimit': '8.27'}, {'value': '2.66', 'groupId': 'OG001', 'lowerLimit': '0.55', 'upperLimit': '4.78'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.40', 'ciLowerLimit': '0.34', 'ciUpperLimit': '6.45', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Testing for a difference between arms'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173).'}, {'type': 'SECONDARY', 'title': 'Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Functional Assessment of Cancer Therapy - General (FACT-G v4)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Comprehensive Score for Financial Toxicity (COST)', 'timeFrame': 'Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Those who indicate financial responsibility will respond to the full 11-item scale of financial toxicity associated with cancer treatment. Respondents rate each item on a 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days. The measure yields a total summary score, with higher scores indicating greater financial strain.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Unmet Needs and Concerns Measured by the Adolescent and Young Adult Oncology Screening Tool (Adapted Version - Young Adults)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Participants first rate their distress on a 0-10 scale. Higher score indicates higher distress. Next, they are asked to check off areas of concern from the past week, including practical (e.g., housing arrangements, work, bills, transportation), family (e.g., parents, siblings, partner), emotional (e.g., sadness, isolation, guilt), social (e.g., isolation from friends, missing important events), physical (e.g., body image, sexual concerns, sleeping difficulty), and informational (e.g., understanding information, feeling involved in decision-making) needs. A total score from 0 to 51 is calculated.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This 25-item self-report measure of five theoretically-important constructs of everyday problem-solving, including positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style. Respondents answer each item on 5-point Likert scale from 0 (not at all true of me) to 4 (extremely true of me). Summary scores ranging from 0-20 are computed for each subscale, as well as an overall score. A higher Total score indicates better problem-solving ability.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'PROMIS Social Isolation - Short Form 4a', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This four-item measure assesses perceptions of social isolation on a 5-point scale from 1 (never) to 5 (always) in the past 7days. Higher scores indicating higher levels of perceived isolation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Support Services Received', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Participants will check whether they have used or received services in the following categories: psychosocial support, informational and practical support, fertility or sexual health, physical/wellness services and integrative medicine services.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}], 'classes': [{'title': 'Utility: User manual', 'categories': [{'measurements': [{'value': '4.02', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Utility: Worksheets', 'categories': [{'measurements': [{'value': '4.00', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Trainer: Warm and supportive', 'categories': [{'measurements': [{'value': '4.74', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Trainer: Competent', 'categories': [{'measurements': [{'value': '4.70', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': "Attitudes: Sessions' length", 'categories': [{'measurements': [{'value': '4.37', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Attitudes: Number of sessions', 'categories': [{'measurements': [{'value': '4.12', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'I liked the BrightIDEAS program', 'categories': [{'measurements': [{'value': '4.37', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Perceived benefit: Effectiveness', 'categories': [{'measurements': [{'value': '4.26', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Perceived benefit: Helpful', 'categories': [{'measurements': [{'value': '4.08', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Would recommend to other YA', 'categories': [{'measurements': [{'value': '4.16', 'spread': '0.96', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time 2 (about 3 months from baseline).', 'description': 'Ten-item scale assesses utility of intervention-specific components (e.g., the user manual, worksheets), attitude towards the intervention, trainer competence, and perceived benefit attributable to the intervention. Participants will answer on a 5 point scale, from 1 (strongly disagree) to 5 (strongly agree) with higher scores indicating higher satisfaction. This measure will be administered at post-intervention to intervention arm only.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intervention Arm only'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}, {'id': 'FG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}], 'periods': [{'title': 'Baselined and Randomized', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Intervention', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to schedule', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Started but did not finish (<4 sessions)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'FU Time 2 (3 months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '142'}, {'groupId': 'FG001', 'numSubjects': '154'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'FU Time 3 (6 months) Primary outcomes', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Dates of recruitment: 2/10/2021- 3/12/24 Recruitment modes: in-person (in clinic), and remote (via email and phone).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.\n\nBright IDEAS-YA: Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.'}, {'id': 'BG001', 'title': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30.00', 'spread': '6.62', 'groupId': 'BG000'}, {'value': '30.58', 'spread': '5.98', 'groupId': 'BG001'}, {'value': '30.3', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '215', 'groupId': 'BG002'}]}]}, {'title': 'Non-Binary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '134', 'groupId': 'BG000'}, {'value': '146', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '222', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '173', 'groupId': 'BG001'}, {'value': '344', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-18', 'size': 290590, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-11-11T11:30', 'hasProtocol': True}, {'date': '2022-08-08', 'size': 226435, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-25T18:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 344}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-12', 'studyFirstSubmitDate': '2020-10-05', 'resultsFirstSubmitDate': '2025-09-25', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-12', 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comprehensive Score for Financial Toxicity (COST)', 'timeFrame': 'Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Those who indicate financial responsibility will respond to the full 11-item scale of financial toxicity associated with cancer treatment. Respondents rate each item on a 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days. The measure yields a total summary score, with higher scores indicating greater financial strain.'}, {'measure': 'Unmet Needs and Concerns Measured by the Adolescent and Young Adult Oncology Screening Tool (Adapted Version - Young Adults)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Participants first rate their distress on a 0-10 scale. Higher score indicates higher distress. Next, they are asked to check off areas of concern from the past week, including practical (e.g., housing arrangements, work, bills, transportation), family (e.g., parents, siblings, partner), emotional (e.g., sadness, isolation, guilt), social (e.g., isolation from friends, missing important events), physical (e.g., body image, sexual concerns, sleeping difficulty), and informational (e.g., understanding information, feeling involved in decision-making) needs. A total score from 0 to 51 is calculated.'}, {'measure': 'Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This 25-item self-report measure of five theoretically-important constructs of everyday problem-solving, including positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style. Respondents answer each item on 5-point Likert scale from 0 (not at all true of me) to 4 (extremely true of me). Summary scores ranging from 0-20 are computed for each subscale, as well as an overall score. A higher Total score indicates better problem-solving ability.'}, {'measure': 'PROMIS Social Isolation - Short Form 4a', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This four-item measure assesses perceptions of social isolation on a 5-point scale from 1 (never) to 5 (always) in the past 7days. Higher scores indicating higher levels of perceived isolation.'}, {'measure': 'Support Services Received', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 3 (about 6 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Participants will check whether they have used or received services in the following categories: psychosocial support, informational and practical support, fertility or sexual health, physical/wellness services and integrative medicine services.'}, {'measure': 'Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure', 'timeFrame': 'Time 2 (about 3 months from baseline).', 'description': 'Ten-item scale assesses utility of intervention-specific components (e.g., the user manual, worksheets), attitude towards the intervention, trainer competence, and perceived benefit attributable to the intervention. Participants will answer on a 5 point scale, from 1 (strongly disagree) to 5 (strongly agree) with higher scores indicating higher satisfaction. This measure will be administered at post-intervention to intervention arm only.'}], 'primaryOutcomes': [{'measure': 'Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.'}, {'measure': 'Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10, with higher scores indicating higher symptoms. The change in T-score points from baseline to 6 months will be examined, with positive scores indicating increasing symptoms and negative scores indicating decreasing symptoms.'}, {'measure': 'Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)', 'timeFrame': 'From Baseline to Time 3 (about 6 months from baseline)', 'description': 'This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.'}], 'secondaryOutcomes': [{'measure': 'Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.'}, {'measure': 'Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.'}, {'measure': 'Functional Assessment of Cancer Therapy - General (FACT-G v4)', 'timeFrame': 'Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).', 'description': 'This 27-item measures health-related quality of life and yields an overall General Total score and four subscales: Physical Well-Being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB). Respondents rate each item on 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days, where higher numbers indicate higher health state. Each scale is a summary of responses, ranging from 0 to 28 for PWB, SWB, and FWB, 0 to 24 for EWB, and 0 to 108 for General Total.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Young Adults', 'Cancer', 'Supportive Care'], 'conditions': ['Cancer Patients', 'Young Adult', 'Supportive Care']}, 'referencesModule': {'references': [{'pmid': '40205419', 'type': 'DERIVED', 'citation': 'Bono MH, Reese S, Levonyan-Radloff K, Donovan KA, Sahler OJZ, Barnett ME, Collins M, Devine KA. "There\'s a lot of unknowns": a thematic analysis of the experiences of young adults with cancer who died during a psychosocial intervention trial. BMC Palliat Care. 2025 Apr 9;24(1):98. doi: 10.1186/s12904-025-01725-2.'}, {'pmid': '39111386', 'type': 'DERIVED', 'citation': 'Devine KA, Ohman-Strickland P, Barnett M, Donovan KA, Thompson LMA, Manne SL, Kearney J, Levonyan-Radloff K, Diaz D, Dugad S, Sahler OJZ. Protocol of a Multisite Randomized Controlled Trial of Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress among Young Adults with Cancer. Contemp Clin Trials. 2024 Oct;145:107656. doi: 10.1016/j.cct.2024.107656. Epub 2024 Aug 5.'}, {'pmid': '36367717', 'type': 'DERIVED', 'citation': 'Kwok G, Reese S, Dugad S, Donovan KA, Tsui J, Sahler OJZ, Levonyan-Radloff K, Barnett ME, Manne S, Ohman-Strickland P, Devine KA. Factors Associated with COVID-19 Vaccine Uptake Among Adolescents and Young Adults Recently Diagnosed with Cancer. J Adolesc Young Adult Oncol. 2024 Apr;13(2):352-357. doi: 10.1089/jayao.2022.0113. Epub 2022 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to evaluate efficacy of Bright IDEAS, an evidence-based problem-solving skills training (PSST) program, as a supportive care intervention for young adult (YA) cancer patients compared with enhanced usual psychosocial care with 344 young adult patients newly diagnosed with cancer.', 'detailedDescription': 'Bright IDEAS-YA is a personalized approach to increase problem-solving ability by fostering positive appraisal of problems as solvable challenges that can be overcome and enhancing rational problem-solving skills to systematically work through any problem. Bright IDEAS-YA intervention consists of six 45-minute one-on-one sessions with a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.\n\nUp to 344 young adult patients newly diagnosed with cancer will be recruited to participate in this multi-site randomized controlled trial, where the Bright IDEAS-YA intervention will be compared with enhanced usual psychosocial care. Efficacy will be evaluated by examining changes in psychosocial outcomes from baseline to post-intervention (3 months) and follow-up (6, 12 and 24 months). The extent to which changes in aspects of problem-solving ability mediate the intervention effects will be examined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Current age 18-39\n* Within 4 months of first diagnosis of any cancer\n* Cancer being treated with chemotherapy and/or radiation therapy and/or hematopoietic stem cell transplant\n* No documented or self-reported cognitive delay or impairment that would prevent completion of survey measures\n* English-speaking\n\nExclusion Criteria:\n\n* Medical crisis or not receiving curative therapy per physician/treatment team report\n* Treatment involves surgery only'}, 'identificationModule': {'nctId': 'NCT04585269', 'briefTitle': 'Bright IDEAS - Young Adults Problem-Solving Skills Training', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress Among Young Adults With Cancer', 'orgStudyIdInfo': {'id': 'Pro2019002928'}, 'secondaryIdInfos': [{'id': '1R37CA240807-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R37CA240807-01A1', 'type': 'NIH'}, {'id': '131911', 'type': 'OTHER', 'domain': 'CINJ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bright IDEAS-YA', 'description': 'Intervention consists of six 45-minute one-on-one sessions between a patient and a trainer, who teaches the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach and worksheets. In addition, participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer Network (NCCN) adolescent and young adult patient guidelines.', 'interventionNames': ['Behavioral: Bright IDEAS-YA']}, {'type': 'NO_INTERVENTION', 'label': 'Enhanced Usual Care', 'description': 'Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.'}], 'interventions': [{'name': 'Bright IDEAS-YA', 'type': 'BEHAVIORAL', 'description': 'Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.', 'armGroupLabels': ['Bright IDEAS-YA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Katie Devine, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'After conclusion of the study', 'ipdSharing': 'YES', 'description': 'A final de-identified data set will be made available to researchers with appropriate qualifications for research purposes upon request.', 'accessCriteria': 'Investigators with appropriate credentials'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, {'name': 'University of Rochester', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Pediatrics', 'investigatorFullName': 'Katie Devine, PhD, MPH', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}