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Behavioral Intervention

Problem-Solving Skills Training for Young Adult Cancer Patients

N/A

Recruiting

Led By Katie Devine, PhD, MPH

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cancer being treated with chemotherapy and/or radiation therapy and/or hematopoietic stem cell transplant

Within 4 months of first diagnosis of any cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

Study Summary

This trial will compare the effectiveness of an evidence-based problem-solving skills training program to enhanced usual care in young adult cancer patients.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves psychological support rather than medication, traditional side effects like you'd expect from drugs aren't relevant here. However, participants may experience emotional discomfort when discussing personal issues during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I was diagnosed with cancer less than 4 months ago.

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I am between 18 and 39 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

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

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

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

Other outcome measures

Comprehensive Score for Financial Toxicity (COST)

PROMIS Social Isolation - Short Form 4a

Satisfaction with intervention derived from the Multi-Dimensional Treatment Satisfaction Measure

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bright IDEAS-YAExperimental Treatment1 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 CareActive Control1 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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteOTHER

543 Previous Clinical Trials

135,151 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterOTHER

1,936 Previous Clinical Trials

588,537 Total Patients Enrolled

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

63,888 Total Patients Enrolled

Media Library

Bright IDEAS-YA (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04585269 — N/A

Cancer Research Study Groups: Bright IDEAS-YA, Enhanced Usual Care

Cancer Clinical Trial 2023: Bright IDEAS-YA Highlights & Side Effects. Trial Name: NCT04585269 — N/A

Bright IDEAS-YA (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04585269 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial have an age cutoff, and if so, what is the limit?

"This trial is meant for patients aged 18 to 39, however there are other trials in the registry that accommodate those under the age of majority and above retirement. Specifically 4 clinical studies target minors while 11 focus on seniors."

Answered by AI

Is this research project currently accepting volunteers?

"Affirmative. According to clinicaltrials.gov, this medical inquiry that was first posted on the 10th of February 2021 is still recruiting participants. A total of 344 patients from 3 specified sites are needed for full enrollment in the trial."

Answered by AI

What is the total size of the cohort being evaluated in this research?

"To commence the trial, 344 participants who are eligible and meet all of the required criteria must be recruited. These individuals can sign up at locations including Rutgers Cancer Institute of New jersey in New Brunswick, NJ or Memorial Sloan Kettering Cancer Center in NYC."

Answered by AI

What are the eligibility criteria for participating in this trial?

"This experiment is attempting to recruit 344 participants aged 18-39 who have recently been diagnosed with cancer. This trial necessitates that prospective members are within 4 months of diagnosis, undergoing treatment via chemotherapy/radiation therapy/stem cell transplantation, able to comprehend English language survey measures and do not possess any cognitive complications that would impede completion of the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bright IDEAS - Young Adults Problem-Solving Skills Training

Katie Devine, PhD, MPH 2021. "Bright IDEAS - Young Adults Problem-Solving Skills Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04585269.