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| ID | Type | Description | Link |
|---|---|---|---|
| 1R37CA240807-01A1 | U.S. NIH Grant/Contract | View source | |
| 131911 | Other Identifier | CINJ |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Memorial Sloan Kettering Cancer Center | OTHER |
| H. Lee Moffitt Cancer Center and Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright IDEAS-YA | Experimental | 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. |
|
| Enhanced Usual Care | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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, 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. | 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, 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. | 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katie Devine, PhD, MPH | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States | ||
| Rutgers Cancer Institute of New Jersey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42012831 | Derived | Devine KA, Barnett M, Donovan KA, Thompson LMA, Manne SL, Kearney J, Levonyan-Radloff K, Diaz DB, Anderson I, Li S, Ohman-Strickland P, Sahler OJZ. Bright IDEAS-YA Skills Training and Psychosocial Outcomes of Young Adults With Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2026 Apr 1;9(4):e267997. doi: 10.1001/jamanetworkopen.2026.7997. | |
| 40205419 | Derived | Bono MH, Reese S, Levonyan-Radloff K, Donovan KA, Sahler OJZ, Barnett ME, Collins M, Devine KA. "There's a lot of unknowns": a thematic analysis of the experiences of young adults with cancer who died during a psychosocial intervention trial. BMC Palliat Care. 2025 Apr 9;24(1):98. doi: 10.1186/s12904-025-01725-2. |
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A final de-identified data set will be made available to researchers with appropriate qualifications for research purposes upon request.
After conclusion of the study
Investigators with appropriate credentials
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Dates of recruitment: 2/10/2021- 3/12/24 Recruitment modes: in-person (in clinic), and remote (via email and phone).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baselined and Randomized |
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| Intervention |
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| FU Time 2 (3 months) |
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| FU Time 3 (6 months) Primary outcomes |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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, 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. | Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173) | Posted | Mean | 95% Confidence Interval | T-score points | From Baseline to Time 3 (about 6 months from baseline) |
|
From Baseline and Randomization, through FU Time 3 (6 months). Adverse event data collection is still ongoing and will be updated upon study completion, and additional adverse event data can be added when they become available.
Study team was notified by Epic or medical record (automatically)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death due to disease progression | General disorders | Non-systematic Assessment | Participants' death was due to their disease progression, which can be expected when working with patients with cancer. Death was unrelated to the study, which is evaluating a supportive care problem-solving intervention to reduce distress. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Katie Devine (PI) | Rutgers Cancer Institute | 7322357549 | katie.devine@rutgers.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 18, 2025 | Nov 11, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Jan 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| University of Rochester |
| OTHER |
This is a two-arm parallel randomized controlled trial (RCT) of the intervention versus enhanced usual psychosocial care.
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|
| 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). |
| 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). |
| 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 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. | Time 2 (about 3 months from baseline). |
| New Brunswick |
| New Jersey |
| 08901 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| 39111386 | Derived | Devine KA, Ohman-Strickland P, Barnett M, Donovan KA, Thompson LMA, Manne SL, Kearney J, Levonyan-Radloff K, Diaz D, Dugad S, Sahler OJZ. Protocol of a Multisite Randomized Controlled Trial of Bright IDEAS-Young Adults: Problem-Solving Skills Training to Reduce Distress among Young Adults with Cancer. Contemp Clin Trials. 2024 Oct;145:107656. doi: 10.1016/j.cct.2024.107656. Epub 2024 Aug 5. |
| 36367717 | Derived | 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. |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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.
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.
| OG001 | 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. |
|
|
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| Primary | 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, 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. | Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173) | Posted | Mean | 95% Confidence Interval | T-score points | From Baseline to Time 3 (about 6 months from baseline) |
|
|
|
|
| Primary | 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. | Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173). | Posted | Mean | 95% Confidence Interval | score on a scale | From Baseline to Time 3 (about 6 months from baseline) |
|
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|
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| Secondary | 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. | Not Posted | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Participants |
| Secondary | 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. | Not Posted | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Participants |
| Secondary | 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. | Not Posted | Baseline, Time 2 (about 3 months from baseline), Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Participants |
| Other Pre-specified | 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. | Not Posted | Baseline, Time 4 (about 12 months from baseline), Time 5 (about 24 months from baseline). | Participants |
| Other Pre-specified | 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. | Not Posted | 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 |
| Other Pre-specified | 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. | Not Posted | 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 |
| Other Pre-specified | 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. | Not Posted | 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 |
| Other Pre-specified | 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. | Not Posted | 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 |
| Other Pre-specified | 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 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. | Intervention Arm only | Posted | Mean | Standard Deviation | score on a scale | Time 2 (about 3 months from baseline). |
|
|
|
| 6 |
| 171 |
| 6 |
| 171 |
| 0 |
| 171 |
| EG001 | 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. | 3 | 173 | 3 | 173 | 0 | 173 |
|
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| Title | Measurements |
|---|---|
|
| Trainer: Competent |
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| Attitudes: Sessions' length |
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| Attitudes: Number of sessions |
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| I liked the BrightIDEAS program |
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| Perceived benefit: Effectiveness |
|
| Perceived benefit: Helpful |
|
| Would recommend to other YA |
|