Trial Outcomes & Findings for Bright IDEAS - Young Adults Problem-Solving Skills Training (NCT NCT04585269)
NCT ID: NCT04585269
Last Updated: 2025-11-25
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
344 participants
From Baseline to Time 3 (about 6 months from baseline)
2025-11-25
Participant Flow
Dates of recruitment: 2/10/2021- 3/12/24 Recruitment modes: in-person (in clinic), and remote (via email and phone).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Baselined and Randomized
STARTED
|
173
|
171
|
|
Baselined and Randomized
COMPLETED
|
173
|
171
|
|
Baselined and Randomized
NOT COMPLETED
|
0
|
0
|
|
Intervention
STARTED
|
173
|
171
|
|
Intervention
COMPLETED
|
173
|
123
|
|
Intervention
NOT COMPLETED
|
0
|
48
|
|
FU Time 2 (3 months)
STARTED
|
173
|
162
|
|
FU Time 2 (3 months)
COMPLETED
|
154
|
142
|
|
FU Time 2 (3 months)
NOT COMPLETED
|
19
|
20
|
|
FU Time 3 (6 months) Primary outcomes
STARTED
|
171
|
156
|
|
FU Time 3 (6 months) Primary outcomes
COMPLETED
|
146
|
134
|
|
FU Time 3 (6 months) Primary outcomes
NOT COMPLETED
|
25
|
22
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Intervention
Withdrawal by Subject
|
0
|
9
|
|
Intervention
Unable to schedule
|
0
|
15
|
|
Intervention
Started but did not finish (<4 sessions)
|
0
|
24
|
|
FU Time 2 (3 months)
Death
|
2
|
2
|
|
FU Time 2 (3 months)
Lost to Follow-up
|
17
|
14
|
|
FU Time 2 (3 months)
Withdrawal by Subject
|
0
|
4
|
|
FU Time 3 (6 months) Primary outcomes
Death
|
1
|
4
|
|
FU Time 3 (6 months) Primary outcomes
Lost to Follow-up
|
24
|
16
|
|
FU Time 3 (6 months) Primary outcomes
Physician Decision
|
0
|
2
|
Baseline Characteristics
Bright IDEAS - Young Adults Problem-Solving Skills Training
Baseline characteristics by cohort
| Measure |
Bright IDEAS-YA
n=171 Participants
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.
|
Enhanced Usual Care
n=173 Participants
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
|
Total
n=344 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.00 years
STANDARD_DEVIATION 6.62 • n=45 Participants
|
30.58 years
STANDARD_DEVIATION 5.98 • n=12929 Participants
|
30.3 years
STANDARD_DEVIATION 6.3 • n=6349 Participants
|
|
Sex/Gender, Customized
Male
|
60 Participants
n=45 Participants
|
68 Participants
n=12929 Participants
|
128 Participants
n=6349 Participants
|
|
Sex/Gender, Customized
Female
|
111 Participants
n=45 Participants
|
104 Participants
n=12929 Participants
|
215 Participants
n=6349 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=45 Participants
|
27 Participants
n=12929 Participants
|
64 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
134 Participants
n=45 Participants
|
146 Participants
n=12929 Participants
|
280 Participants
n=6349 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
0 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=45 Participants
|
0 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=45 Participants
|
20 Participants
n=12929 Participants
|
43 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=45 Participants
|
1 Participants
n=12929 Participants
|
1 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=45 Participants
|
17 Participants
n=12929 Participants
|
38 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
White
|
105 Participants
n=45 Participants
|
117 Participants
n=12929 Participants
|
222 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=45 Participants
|
7 Participants
n=12929 Participants
|
13 Participants
n=6349 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=45 Participants
|
11 Participants
n=12929 Participants
|
26 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
171 Participants
n=45 Participants
|
173 Participants
n=12929 Participants
|
344 Participants
n=6349 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Time 3 (about 6 months from baseline)Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)
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.
Outcome measures
| Measure |
Bright IDEAS-YA
n=171 Participants
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.
|
Enhanced Usual Care
n=173 Participants
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
|
|---|---|---|
|
Change in Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8a)
|
-2.92 T-score points
Interval -4.14 to -1.69
|
0.31 T-score points
Interval -0.86 to 1.49
|
PRIMARY outcome
Timeframe: From Baseline to Time 3 (about 6 months from baseline)Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173)
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.
Outcome measures
| Measure |
Bright IDEAS-YA
n=171 Participants
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.
|
Enhanced Usual Care
n=173 Participants
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
|
|---|---|---|
|
Change in Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
|
-2.21 T-score points
Interval -3.38 to -1.04
|
0.22 T-score points
Interval -0.9 to 1.34
|
PRIMARY outcome
Timeframe: From Baseline to Time 3 (about 6 months from baseline)Population: Intent-to-treat analyses included all randomized participants (Intervention n = 171; Control n = 173).
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.
Outcome measures
| Measure |
Bright IDEAS-YA
n=171 Participants
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.
|
Enhanced Usual Care
n=173 Participants
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
|
|---|---|---|
|
Change in Functional Assessment of Cancer Therapy - General (FACT-G v4)
|
6.06 score on a scale
Interval 3.85 to 8.27
|
2.66 score on a scale
Interval 0.55 to 4.78
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
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).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
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).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
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).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
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).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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time 2 (about 3 months from baseline).Population: Intervention Arm only
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.
Outcome measures
| Measure |
Bright IDEAS-YA
n=171 Participants
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.
|
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.
|
|---|---|---|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Perceived benefit: Helpful
|
4.08 score on a scale
Standard Deviation 0.85
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Utility: User manual
|
4.02 score on a scale
Standard Deviation 0.79
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Utility: Worksheets
|
4.00 score on a scale
Standard Deviation 0.82
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Trainer: Warm and supportive
|
4.74 score on a scale
Standard Deviation 0.63
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Trainer: Competent
|
4.70 score on a scale
Standard Deviation 0.63
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Attitudes: Sessions' length
|
4.37 score on a scale
Standard Deviation 0.75
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Attitudes: Number of sessions
|
4.12 score on a scale
Standard Deviation 0.90
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
I liked the BrightIDEAS program
|
4.37 score on a scale
Standard Deviation 0.67
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Perceived benefit: Effectiveness
|
4.26 score on a scale
Standard Deviation 0.73
|
—
|
|
Satisfaction With Intervention Derived From the Multi-Dimensional Treatment Satisfaction Measure
Would recommend to other YA
|
4.16 score on a scale
Standard Deviation 0.96
|
—
|
Adverse Events
Bright IDEAS-YA
Enhanced Usual Care
Serious adverse events
| Measure |
Bright IDEAS-YA
n=171 participants at risk
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.
|
Enhanced Usual Care
n=173 participants at risk
Participants in this arm will receive a standardized list of resources from the National Comprehensive Cancer network (NCCN) adolescent and young adult patient guidelines.
|
|---|---|---|
|
General disorders
Death due to disease progression
|
3.5%
6/171 • Number of events 6 • 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)
|
1.7%
3/173 • Number of events 3 • 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)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place