Clinical trial NCT04585269: Bright IDEAS - Young Adults Problem-Solving Skills Training
Official title: Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress Among Young Adults With Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Patients
Young Adult
Supportive Care
Keywords: Young Adults
Cancer
Supportive Care
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Memorial Sloan Kettering Cancer Center
name: H. Lee Moffitt Cancer Center and Research Institute
name: University of Rochester
First posted: 2020-10-14
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)
timeFrame: From Baseline to Time 3 (about 6 months from baseline)
measure: Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
timeFrame: From Baseline to Time 3 (about 6 months from baseline)
measure: Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)
timeFrame: From Baseline to Time 3 (about 6 months from baseline)
Secondary outcomes:
measure: Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)
timeFrame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
measure: Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
timeFrame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
measure: Functional Assessment of Cancer Therapy - General (FACT-G v4)
timeFrame: Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
Other outcomes:
measure: Comprehensive Score for Financial Toxicity (COST)
timeFrame: Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline).
measure: Unmet needs and concerns measured by the Adolescent and Young Adult Oncology Screening Tool (adapted version - young adults)
timeFrame: 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).
measure: Social Problem-Solving Inventory-Revised Short Form (SPSI-R:S)
timeFrame: 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).
measure: PROMIS Social Isolation - Short Form 4a
timeFrame: 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).
measure: Support Services Received
timeFrame: 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).
measure: Satisfaction with intervention derived from the Multi-Dimensional Treatment Satisfaction Measure
timeFrame: Time 2 (about 3 months from baseline).
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Katie Devine, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Apr;13(2):352-357. doi: 10.1089/jayao.2022.0113. Epub 2022 Nov 11.