Bright IDEAS - Young Adults Problem-Solving Skills Training
NCT ID: NCT04585269
Last Updated: 2025-11-25
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
NA
344 participants
INTERVENTIONAL
2021-02-10
2026-04-30
Brief Summary
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Detailed Description
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Up 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Bright IDEAS-YA
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.
Bright 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.
Enhanced Usual Care
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
No interventions assigned to this group
Interventions
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Bright 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.
Eligibility Criteria
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Inclusion Criteria
* Within 4 months of first diagnosis of any cancer
* Cancer being treated with chemotherapy and/or radiation therapy and/or hematopoietic stem cell transplant
* No documented or self-reported cognitive delay or impairment that would prevent completion of survey measures
* English-speaking
Exclusion Criteria
* Treatment involves surgery only
18 Years
39 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Memorial Sloan Kettering Cancer Center
OTHER
H. Lee Moffitt Cancer Center and Research Institute
OTHER
University of Rochester
OTHER
Rutgers, The State University of New Jersey
OTHER
Responsible Party
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Katie Devine, PhD, MPH
Associate Professor Pediatrics
Principal Investigators
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Katie Devine, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
Rutgers Cancer Institute of New Jersey
Locations
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H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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References
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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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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131911
Identifier Type: OTHER
Identifier Source: secondary_id
Pro2019002928
Identifier Type: -
Identifier Source: org_study_id
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