Problem-Solving Skills Training for Young Adult Cancer Patients

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

344 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Bright IDEAS-YA for young adult cancer patients?

Bright IDEAS has been shown to improve problem-solving skills and reduce distress in caregivers of children with cancer, suggesting it could help young adult cancer patients cope better with their challenges. ^{1 2 3 4 5}

How is the Bright IDEAS-YA treatment different from other treatments for young adult cancer patients?

Bright IDEAS-YA is unique because it focuses on teaching problem-solving skills to help young adult cancer patients cope with their emotional, social, and practical challenges, unlike other treatments that may not specifically address these needs. This approach has been adapted from a successful program used with caregivers of children with cancer, showing its potential to reduce distress and improve coping skills. ^{1 5 6 7 8}

Research Team

Katie Devine, PhD, MPH

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

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.

I am between 18 and 39 years old.

Exclusion Criteria

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

My treatment plan includes only surgery.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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 (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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Bright IDEAS-Young Adults: A Problem-Solving Skills Training Intervention. [2023]

2. Pakistan pubmed.ncbi.nlm.nih.gov

Perception of problem solving skills in cancer patients according to certain variables and control focus. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Hope and benefit finding: Results from the PRISM randomized controlled trial. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Problem-solving skills training in adult cancer survivors: Bright IDEAS-AC pilot study. [2023]

5. United States 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. [2023]

6. United States 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. [2023]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Responsivity to Problem-Solving Skills Training in Mothers of Children With Cancer. [2021]