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Completed

NCT Number: NCT04585269

Bright IDEAS - Young Adults Problem-Solving Skills Training

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bright IDEAS-YA

Behavioral

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.

Primary outcomes

  1. 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)

    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.

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

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

    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.

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

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

    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.

Secondary outcomes

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

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

    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.

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

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

    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.

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

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

    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.

Other outcomes

  1. Comprehensive Score for Financial Toxicity (COST)

    Time frame: Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).

    Those who indicate financial responsibility will respond to the full 11-item scale of financial toxicity associated with cancer treatment. Respondents rate each item on a 5-point Likert scale from 0 (not at all) to 4 (very much) in the past 7 days. The measure yields a total summary score, with higher scores indicating greater financial strain.

  2. Unmet Needs and Concerns Measured by the Adolescent and Young Adult Oncology Screening Tool (Adapted Version - Young Adults)

    Time frame: 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).

    Participants first rate their distress on a 0-10 scale. Higher score indicates higher distress. Next, they are asked to check off areas of concern from the past week, including practical (e.g., housing arrangements, work, bills, transportation), family (e.g., parents, siblings, partner), emotional (e.g., sadness, isolation, guilt), social (e.g., isolation from friends, missing important events), physical (e.g., body image, sexual concerns, sleeping difficulty), and informational (e.g., understanding information, feeling involved in decision-making) needs. A total score from 0 to 51 is calculated.

  3. Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)

    Time frame: 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 25-item self-report measure of five theoretically-important constructs of everyday problem-solving, including positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style. Respondents answer each item on 5-point Likert scale from 0 (not at all true of me) to 4 (extremely true of me). Summary scores ranging from 0-20 are computed for each subscale, as well as an overall score. A higher Total score indicates better problem-solving ability.

  4. PROMIS Social Isolation - Short Form 4a

    Time frame: 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 four-item measure assesses perceptions of social isolation on a 5-point scale from 1 (never) to 5 (always) in the past 7days. Higher scores indicating higher levels of perceived isolation.

  5. Support Services Received

    Time frame: 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).

    Participants will check whether they have used or received services in the following categories: psychosocial support, informational and practical support, fertility or sexual health, physical/wellness services and integrative medicine services.

  6. Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure

    Time frame: Time 2 (about 3 months from baseline).

    Ten-item scale assesses utility of intervention-specific components (e.g., the user manual, worksheets), attitude towards the intervention, trainer competence, and perceived benefit attributable to the intervention. Participants will answer on a 5 point scale, from 1 (strongly disagree) to 5 (strongly agree) with higher scores indicating higher satisfaction. This measure will be administered at post-intervention to intervention arm only.

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute
  • Memorial Sloan Kettering Cancer Center
  • National Cancer Institute (NCI)
  • University of Rochester

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Oct 14, 2020
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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