Bright IDEAS - Young Adults Problem-Solving Skills Training

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Patients; Supportive Care; Young Adult
• Intervention / Treatment: Behavioral: Bright IDEAS-YA

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rutgers ClinicalTrials.gov PRS Administrator; Phone Number: 973-972-1149; Email: chennr@ored.rutgers.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • H. Lee Moffitt Cancer Center and Research Institute
      • Contact: Diana Diaz; Phone Number: 813-745-1057; Email: Diana.Diaz@moffitt.org
      • Contact: Lora M Thompson, PhD; Phone Number: 813-745-1418; Email: Lora.Thompson@moffitt.org
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Rutgers Cancer Institute of New Jersey
      • Contact: Katie Devine, PhD, MPH; Phone Number: 732-235-7549; Email: Katie.devine@rutgers.edu
      • Contact: Kristine Levonyan-Radloff; Phone Number: 732-509-6150; Email: kl747@cinj.rutgers.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Marie Barnett, PhD; Phone Number: 646-608-8206; Email: barnettm@mskcc.org
      • Contact: Julia Kearney, MD; Phone Number: 646-888-0028; Email: kearneyj@mskcc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bright IDEAS-YA; 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; 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.
No Intervention: Enhanced Usual Care; 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?

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), Time 5 (about 24 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), Time 5 (about 24 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), Time 5 (about 24 months from baseline).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with intervention derived from the Multi-Dimensional Treatment Satisfaction Measure	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 0 (strongly disagree) to 4 (strongly agree) with higher scores indicating higher satisfaction. This measure will be administered at post-intervention to intervention arm only.	Time 2 (about 3 months from baseline).
Comprehensive Score for Financial Toxicity (COST)	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.	Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Unmet needs and concerns measured by the Adolescent and Young Adult Oncology Screening Tool (adapted version - young adults)	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.	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).
Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)	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.	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).
PROMIS Social Isolation - Short Form 4a	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.	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).
Support Services Received	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.	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).

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: National Cancer Institute (NCI); Memorial Sloan Kettering Cancer Center; University of Rochester; H. Lee Moffitt Cancer Center and Research Institute
• Investigators: Principal Investigator: Katie Devine, PhD, MPH, Rutgers Cancer Institute of New Jersey

Publications and helpful links

General Publications

• Kwok G, Reese S, Dugad S, Donovan KA, Tsui J, Sahler OJZ, Levonyan-Radloff K, Barnett ME, Manne S, Ohman-Strickland P, Devine KA. Factors Associated with COVID-19 Vaccine Uptake Among Adolescents and Young Adults Recently Diagnosed with Cancer. J Adolesc Young Adult Oncol. 2022 Nov 11. doi: 10.1089/jayao.2022.0113. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cancer; Supportive Care; Young Adults
• Other Study ID Numbers: Pro2019002928; 1R37CA240807-01A1 (U.S. NIH Grant/Contract); 131911 (Other Identifier: CINJ)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A final de-identified data set will be made available to researchers with appropriate qualifications for research purposes upon request.
• IPD Sharing Time Frame: After conclusion of the study
• IPD Sharing Access Criteria: Investigators with appropriate credentials
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No