Problem-Solving Skills Training for Young Adult Cancer Patients

Not currently recruiting at 2 trial locations

Overseen By Rutgers ClinicalTrials.gov PRS Administrator

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Medical crisis, Surgery only, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Bright IDEAS-YA to determine if it helps young adults newly diagnosed with cancer manage their challenges more effectively. Bright IDEAS-YA includes six one-on-one sessions aimed at improving problem-solving skills. Researchers will compare this program to the usual care, which provides a list of helpful resources. The trial seeks young adults aged 18-39 who have been diagnosed with cancer within the last four months and are undergoing treatments such as chemotherapy or radiation. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance support for young adults with cancer.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a problem-solving program rather than changing your medical treatment.

What prior data suggests that the Bright IDEAS-YA program is safe for young adult cancer patients?

Research shows that the Bright IDEAS-YA program effectively supports young adults with cancer. Participants found the program easy to use and helpful. Studies have shown that this program, which includes six one-on-one sessions to aid in problem-solving, is well-liked and has no known physical side effects. As a supportive care program, not a medication or medical procedure, it has no reported negative effects. Overall, the program helps young adults manage stress and enhance their problem-solving skills, improving life during treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Bright IDEAS-YA intervention because it offers a unique approach to helping young adult cancer patients through problem-solving skills training. Unlike traditional treatments focused primarily on medical or psychological interventions, Bright IDEAS-YA involves six one-on-one sessions where a trainer guides patients to tackle their personal problems using a stepwise method and practical worksheets. This hands-on, personalized approach empowers patients to actively manage their challenges, potentially enhancing their overall well-being and quality of life during cancer treatment. Additionally, it aligns with standardized resources from the National Comprehensive Cancer Network, providing a solid foundation of support.

What evidence suggests that the Bright IDEAS-YA program is effective for young adult cancer patients?

Research has shown that Bright IDEAS-YA, which participants in this trial may receive, helps young adults with cancer feel less distressed, depressed, and anxious. Studies have found that patients using this problem-solving skills training report a better quality of life. They also improve their problem-solving abilities and experience fewer symptoms of depression and anxiety. The program includes six one-on-one sessions that teach patients a step-by-step method to handle their problems, which has proven helpful. Overall, Bright IDEAS-YA is a promising support program for young adult cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Katie Devine, PhD, MPH

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-39 who have been diagnosed with cancer within the last 4 months and are undergoing chemotherapy, radiation therapy, or stem cell transplant. They must be English-speaking without cognitive impairments that would affect survey completion. It's not for those treated by surgery only or in medical crisis/not receiving curative therapy.

Inclusion Criteria

I am currently receiving chemotherapy, radiation therapy, or a stem cell transplant for my cancer.

I was diagnosed with cancer less than 4 months ago.

No documented or self-reported cognitive delay or impairment that would prevent completion of survey measures

Exclusion Criteria

My doctor says my treatment isn't aimed at curing my disease.

My treatment plan includes only surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Bright IDEAS-YA intervention consisting of six 45-minute one-on-one sessions with a trainer

3 months

6 visits (in-person)

Follow-up

Participants are monitored for changes in psychosocial outcomes and problem-solving ability

24 months

4 visits (in-person) at 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Bright IDEAS-YA

Trial Overview The Bright IDEAS program is being tested to see if it helps young adult cancer patients better than usual care does. The program teaches problem-solving skills as a form of supportive care to manage the challenges of their diagnosis and treatment.

How Is the Trial Designed?

Group I: Bright IDEAS-YA Experimental Treatment 1 Intervention

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.

Group II: Enhanced Usual Care Active Control 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

H. Lee Moffitt Cancer Center and Research Institute

Collaborator

Trials

576

Recruited

145,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The Bright IDEAS (BI) problem-solving skills training has been shown to effectively reduce distress in caregivers of children newly diagnosed with cancer, based on data from over 1400 caregivers in four multisite randomized clinical trials.

The training program successfully educated 209 psychosocial professionals across 134 sites, who have since provided BI to 545 individuals, although further efforts are needed to integrate BI into routine pediatric oncology care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of an evidence-based behavioral intervention to alleviate distress in caregivers of children recently diagnosed with cancer: Bright IDEAS. Voll, M., Fairclough, DL., Morrato, EH., et al.[2023]

The Bright IDEAS problem-solving skills training (BI) was successfully adapted for caregivers of children with sickle cell disease, achieving a high recruitment rate of 94% (72 participants) and a reasonable retention rate of 49%, with 35 caregivers completing the program.

Caregivers who completed the BI program reported significant improvements in their problem-solving skills immediately after and three months post-intervention, while initial levels of distress were low and remained stable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright IDEAS problem-solving skills training for caregivers of children with sickle cell disease: A two-site pilot feasibility trial. Young, M., Voll, M., Noll, RB., et al.[2023]

The PRISM intervention significantly improved coping skills related to benefit finding and hopeful thinking in adolescents and young adults with cancer, with moderate-to-large effect sizes observed in a study of 92 participants.

Despite the positive effects on benefit finding and hope, PRISM did not show a significant impact on goal setting, suggesting that while it enhances certain coping strategies, further development may be needed to address goal-setting skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hope and benefit finding: Results from the PRISM randomized controlled trial. Rosenberg, AR., Bradford, MC., Barton, KS., et al.[2020]

The Bright IDEAS-YA intervention, adapted for young adults with cancer, showed good feasibility with 67.8% enrollment and 80.0% retention rates, indicating it is acceptable for this population.

Participants reported improvements in problem-solving skills and reductions in symptoms of depression and anxiety after completing the intervention, suggesting it may effectively address their unique emotional and social needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Bright IDEAS-Young Adults: A Problem-Solving Skills Training Intervention. Viola, AS., Kwok, G., Levonyan-Radloff, K., et al.[2023]

The Bright IDEAS problem-solving skills training (PSST) intervention significantly reduces anxiety, depression, and post-traumatic stress symptoms in mothers of children recently diagnosed with cancer, with lasting benefits observed at a 3-month follow-up after the intervention.

In contrast to the nondirective support (NDS) intervention, which only provided temporary benefits during the sessions, PSST led to continued improvements in emotional well-being, highlighting the importance of teaching coping skills for long-term family resilience during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Specificity of problem-solving skills training in mothers of children newly diagnosed with cancer: results of a multisite randomized clinical trial. Sahler, OJ., Dolgin, MJ., Phipps, S., et al.[2022]

In a study of 154 mothers participating in the Bright IDEAS problem-solving skills training program, 33% showed significant improvement in problem-solving skills immediately after treatment, with this rate increasing to 39% at follow-up.

Lower baseline problem-solving skills were a strong predictor of greater improvement, suggesting that targeting individuals with poorer skills may enhance the effectiveness of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. Dolgin, MJ., Devine, KA., Tzur-Bitan, D., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.12005

Results of a multisite randomized trial of Bright IDEAS ... This randomized trial evaluated the efficacy of Bright IDEAS-YA, a problem-solving skills training intervention, on reducing distress and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9264826/

Feasibility and Acceptability of Bright IDEAS-Young Adults In conclusion, the Bright IDEAS-YA intervention was both feasible and acceptable to young adults diagnosed with cancer. In addition, our results ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1551714424002398

Problem-Solving Skills Training to Reduce Distress among ... This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer.

4. hematologyadvisor.com hematologyadvisor.com/reports/cancer-bright-ideas-young-adult-reduces-depression-anxiety-treatment-risk/

Bright IDEAS-YA Reduces Depression and Anxiety Among ... Bright IDEAS-YA is an efficacious intervention to reduce distress and anxiety and improve quality of life among young adults recently diagnosed with cancer.

5. reporter.nih.gov reporter.nih.gov/project-details/10954568

Bright IDEAS-Young Adults: Problem-Solving Skills Training to ... Patients who received Bright IDEAS-YA showed improvements in problem-solving ability and reductions in symptoms of depression and anxiety.

6. trialx.com trialx.com/clinical-trials/listings/256993/bright-ideas-young-adults-problem-solving-skills-training/

Bright IDEAS - Young Adults Problem-Solving Skills Training Up to 344 young adult patients newly diagnosed with cancer will be recruited to participate in this multi-site randomized controlled trial, ...

7. researchwithrutgers.com researchwithrutgers.com/en/publications/stop-and-think-a-case-study-illustrating-the-implementation-of-br/

A Case Study Illustrating the Implementation of Bright IDEAS ... This case study demonstrates the young adult adaptation of Bright IDEAS – Bright IDEAS-YA – being delivered to a young adult cancer patient via telehealth.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38491206/

A Case Study Illustrating the Implementation of Bright IDEAS ... This case study demonstrates the young adult adaptation of Bright IDEAS - Bright IDEAS-YA - being delivered to a young adult cancer patient via telehealth.

9. mdpi.com mdpi.com/2072-6694/14/13/3124

Feasibility and Acceptability of Bright IDEAS-Young Adults In conclusion, the Bright IDEAS-YA intervention was both feasible and acceptable to young adults diagnosed with cancer. In addition, our results indicate that ...