Bright IDEAS - Young Adults Problem-Solving Skills Training

Study Overview
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Brief Summary
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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.

Detailed Description
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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 and 12 months). The extent to which changes in aspects of problem-solving ability mediate the intervention effects will be examined.

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

Conditions
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Cancer Patients, Young Adult, Supportive Care

Intervention / Treatment
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* Behavioral: Bright IDEAS-YA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Medical crisis or not receiving curative therapy per physician/treatment team report Treatment involves surgery only

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright IDEAS-YA<br>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<br>* 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.<br>|
| No Intervention: Enhanced Usual Care<br>Participants 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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline) | 
| 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. | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline) | 
| 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. | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Young Adults, Cancer, Supportive Care