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Cancer PatientsNCT04585269

Bright IDEAS - Young Adults Problem-Solving Skills Training

A study testing Bright IDEAS-YA in people with Cancer Patients and Young Adult, run by Rutgers, The State University of New Jersey at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Cancer Patients, Young Adult, Supportive Care
What is being tested?
Bright IDEAS-YA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
344 participants
Where
3 sitesUnited States
Study dates
10 Feb 2021to 29 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress Among Young Adults With Cancer

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.

Read the detailed description

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.

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.

Being tested
Bright IDEAS-YA
Keywords
Young Adults, Cancer, Supportive Care
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bright IDEAS-YABehavioural

    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.

Study groups in NCT04585269
Study groupRoleWhat they receive
Bright IDEAS-YAExperimentalIntervention 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.
Receives: Behavioral: Bright IDEAS-YA
Enhanced Usual CareNo interventionParticipants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (3)
  1. 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.

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

  2. 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.

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start10 Feb 2021
  3. Primary completion29 Sep 2024
  4. Study completion29 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.
Masking
None (open label)
Enrolment
344 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585269
Sponsor's protocol ID
Pro2019002928
Other IDs
1R37CA240807-01A1, 131911
Status last verified
Apr 2026
First submitted
5 Oct 2020
Last updated
20 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A final de-identified data set will be made available to researchers with appropriate qualifications for research purposes upon request.

Publications

  • Devine KA, Barnett M, Donovan KA, Thompson LMA, Manne SL, Kearney J, Levonyan-Radloff K, Diaz DB, Anderson I, Li S, Ohman-Strickland P, Sahler OJZ. Bright IDEAS-YA Skills Training and Psychosocial Outcomes of Young Adults With Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e267997. doi: 10.1001/jamanetworkopen.2026.7997.

    PubMed 42012831
  • 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.

    PubMed 40205419
  • 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.

    PubMed 39111386
  • 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.

    PubMed 36367717

Questions about this trial

What is this clinical trial studying?

A study testing Bright IDEAS-YA in people with Cancer Patients and Young Adult, run by Rutgers, The State University of New Jersey at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a) (time frame: From Baseline to Time 3 (about 6 months from baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04585269, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.

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