Bright IDEAS - Young Adults Problem-Solving Skills Training

NCT04585269 | Active Not Recruiting Results DMC

• 3 other identifiers: Pro20190029281R37CA240807-01A1131911
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cancer Patients; Young Adult; Supportive Care

Keywords

Young Adults; Cancer; Supportive Care

Outcome Measures

Primary Outcomes (3)

• Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)

  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.

  From Baseline to Time 3 (about 6 months from baseline)

• Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)

  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.

  From Baseline to Time 3 (about 6 months from baseline)

• Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)

  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.

  From Baseline to Time 3 (about 6 months from baseline)

Secondary Outcomes (3)

• Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)

  Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).

• Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)

  Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).

• Functional Assessment of Cancer Therapy - General (FACT-G v4)

  Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).

Other Outcomes (6)

• Comprehensive Score for Financial Toxicity (COST)

  Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).

• Unmet Needs and Concerns Measured by the Adolescent and Young Adult Oncology Screening Tool (Adapted Version - Young Adults)

  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).

• Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)

  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).

Study Arms (2)

Bright IDEAS-YA

EXPERIMENTAL

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.

Behavioral: Bright IDEAS-YA

Enhanced Usual Care

NO INTERVENTION

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

Bright IDEAS-YA BEHAVIORAL

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.

Bright IDEAS-YA

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Current age 18-39
• 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

You may not qualify if:

• Medical crisis or not receiving curative therapy per physician/treatment team report
• Treatment involves surgery only

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator
• University of Rochester: collaborator

Study Sites (3)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (3)

• 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: 40205419 DERIVED

• 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: 39111386 DERIVED

• 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.

  PMID: 36367717 DERIVED

MeSH Terms

Conditions

Neoplasms

Results Point of Contact

• Title: Dr. Katie Devine (PI)
• Organization: Rutgers Cancer Institute

katie.devine@rutgers.edu

7322357549

Study Officials

• Katie Devine, PhD, MPH

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Pediatrics

Model Details: This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: February 10, 2021
• Primary Completion: September 29, 2024
• Study Completion: April 1, 2026
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After conclusion of the study
• Access Criteria: Investigators with appropriate credentials

Locations

US (3)